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Orthopedic reviews open access journal - eISSN 2035-8164 ı ISSN 2035-8237 ı www.pagepress.org/or
Orthopedic Reviews 2016; volume 8:6256

Treatment of osteoarthritis                         erature is the dual hinge push brace, followed
                                                    by the single hinge pull.                            Correspondence: Steven Phillips, Global
of the knee with bracing:                              While a large increase in the number of           Research Solutions, Inc., 3228 South Service
a scoping review                                    studies evaluating the treatment of knee             Road, Suite 206, Burlington, ON, L7N 3H8
                                                                                                         Canada.
                                                    osteoarthritis with bracing has occurred in the
                                                                                                         E-mail: phillips.steve.a@gmail.com
Steven Phillips,1 Chuan Silvia Li,1,2               past 5 years, there is a lack of high quality
Mark Phillips,1 Markus Bischoff,3                   studies evaluating the efficacy of the tech-         Key words: Knee bracing; osteoarthritis; litera-
Pervez Ali,4,5 Jas Chahal,6 Matthew                 nique, as well as a lack of studies comparing        ture review.
Snider,3,7 Mohit Bhandari8                          bracing types and models.
                                                                                                         Acknowledgements: the authors would like to
1
 Global Research Solutions Inc.,                                                                         thank Sofia Bzovsky, Olivia Yu, and Sarah Gilbert
                                                                                                         for their assistance in data collection.
Burlington, ON; 2Department of Clinical
Epidemiology and Biostatistics, McMaster            Introduction                                         Contributions: the authors contributed equally.
University, Hamilton, ON; 3Division of
Orthopedic Surgery, McMaster                           As one of the leading causes of disability,       Conflict of interest: SP, MP and CSL are employ-
University, Hamilton, ON; 4The                                                                           ees of Global Research Solutions. Dr. Cahal, Dr.
                                                    knee osteoarthritis (OA) results in a substan-
                                                                                                         Ali, Dr. Bischoff and Dr. Snider report no conflicts
Scarborough Hospital, Toronto, ON;                  tial decrease in quality of life from people suf-    of interest. Dr. Bhandari reports personal fees
5Department of Surgery, University of
                                                    fering from the disease, as well as a large eco-     from Smith & Nephew, Stryker, Amgen, Zimmer,
Toronto, ON; 6Toronto Western Hospital              nomic burden on society.1,2 There are numer-         Moximed, Bioventus, Merck, Eli Lilly, Sanofi,
and Women’s College Hospital, University            ous treatment methods available for knee OA          Ferring, Conmed, grants from Smith & Nephew,
of Toronto Orthopedic Sports Medicine               including conservative treatment for milder          DePuy, Eli Lily, Bioventus, Stryker, Zimmer,
                                                                                                         Amgen, outside the submitted work.
Program (UTOSM), Toronto, ON; 7Grand                OA and operative management for severe OA.
River Hospital, Kitchener, ON; 8Division            Current clinical guidelines recommend the            Funding: the work was supported by a grant from
of Orthopedic Surgery, Centre for                   use of conservative treatment options to allevi-     Össur (Reykjavik, Island).
Evidence-Based Orthopedics, McMaster                ate OA related symptoms in order to postpone
University, Hamilton, ON, Canada                    total knee arthroplasty.3                            Received for publication: 14 October 2015.
                                                       Knee bracing offers a conservative, non-          Accepted for publication: 20 October 2015.
                                                    invasive treatment option to alleviate the
                                                                                                         This work is licensed under a Creative Commons
                                                    symptoms of knee OA by decreasing biome-             Attribution NonCommercial 4.0 License (CC BY-
                                                    chanical loads on the knee.4,5 Numerous differ-      NC 4.0).
Abstract                                            ent braces have been developed, evaluated,
                                                    and manufactured.6 These braces are designed         ©Copyright S. Phillips et al., 2016
   Knee osteoarthritis is a leading cause of dis-   to decrease loads within the knee, and accom-        Licensee PAGEPress, Italy
                                                                                                         Orthopedic Reviews 2016;8:6256
ability around the world. Knee bracing pro-         plish so by using various hinge types (single
                                                                                                         doi:10.4081/or.2016.6256
vides a conservative management option for          hinge or dual hinge) as well as decreasing the
symptom relief. A variety of different bracing      load in either the medial or lateral compart-
types, manufacturers and products are cur-          ments of the knee by applying a valgus or varus
rently available on the market. The goal of this    external force to the knee, respectively. The
study is to examine the current state of the lit-   application of this force can be applied either
erature regarding the treatment of knee             by the brace pushing (push brace) or pulling
                                                                                                        Materials and Methods
osteoarthritis with unloader bracing, specifi-      (pull brace) on the knee in order to apply the
cally examining the representation of specific      required force to decrease the load on the tar-     Scoping review methodology
brace types, manufacturers and models within        get compartment of the knee joint.
the literature.                                                                                         overview
                                                       Several systematic review have been pub-
   A scoping review technique was used                                                                     A scoping review is a literature review
                                                    lished evaluating the efficacy of knee bracing
because of its ability to evaluate research                                                             method allowing researchers to summarize a
                                                    in the treatment of knee OA, and a recent liter-
activity within an area of study and identify                                                           range of evidence in order to describe the
                                                    ature review summarized the literature
gaps within the literature. A thorough search                                                           breadth and depth of a field.8 Unlike systematic
                                                    regarding specific brace models.6-8 Although
of the MEDLINE database was conducted for                                                               reviews which address the current literature
                                                    these reviews evaluate and summarize the
articles where a knee brace model was identi-                                                           on a narrow focus, a scoping review addresses
                                                    efficacy of bracing, an examination of trends
fied, and we identified characteristics of the                                                          broader research questions where an abun-
studies to evaluate important information           within the literature regarding brace types and
                                                    manufacturers has not been conducted.               dance of interventions or study designs may be
about the body of literature related to knee                                                            relevant.9 The literature involving the treat-
bracing for the treatment of osteoarthritis.        Therefore, the goal of this scoping review is to
                                                    summarize the state of literature on the use of     ment on knee OA with bracing covers a wide
   Fifty eligible studies were identified. The
                                                    knee braces for the treatment of knee OA. The       variety of bracing types and study designs.
majority of studies have been published in the
United States, and a large increase in the          objectives of this review are: i) to summarize      With little known about the types of literature,
number of publications in this field was seen       the body of literature and examine trends in        or the representation of specific products with-
between 2010-2014. The most prominent study         the treatment of knee OA with bracing and ii)       in the current literature, performing a scoping
type was prospective comparative studies            to determine the representation of different        review to map the extent, range, and nature of
(44%), however there is a lack of randomized        knee bracing manufacturers, models and              available research was the most appropriate
controlled trials (6%) within the literature.       hinge types within the current literature.          synthesis methodology.
The most prominent hinge type within the lit-

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Review

Literature search                                                                                         which 32 studies were duplicates, which left
   A literature search was conducted on knee        Results                                               331 articles for consideration for inclusion in
bracing for the treatment of OA. Using a combi-                                                           this review. We excluded 281 studies due to:
nation of keywords and medical subject heading      Citation retrieval                                    being animal studies (3), not written in
(mesh) terms related to knee OA and bracing,                                                              English (17), were not relevant to bracing
                                                      The search strategy and supplemental
we performed a detailed search of MEDLINE                                                                 (69), did not focus on knee OA (76), the brace
                                                    search identified a total of 363 articles, of
(Table 1). The search was performed in July,
2014. The search was limited to articles pub-
lished up to July, 2014 and to studies published
in English. After the search, a supplemental        Table 1. Search strategy.
search was performed in order to look for any
                                                             Searches                                                             Results
additional articles related to the topic by exam-
ining articles referenced within the articles       1        Braces/or unloader knee brace.mp.                                       4434
retrieved from the initial literature search.       2        Knee brace.mp.                                                           241
                                                    3        Knee osteoarthritis.mp. or osteoarthritis, knee/                       12,050
Study selection
                                                    4        Osteoarthritis.mp. or osteoarthritis/                                  56,155
   Titles and abstracts from the literature
search were compiled and reviewed for eligi-        5        (Osteoarthritis or osteoarthritic).mp. or osteoarthritis/              57,016
bility. Studies were included if they focused on    6        (Brace* or bracing).mp.                                                 8606
the treatment of knee OA using bracing.             7        1 or 2 or 6                                                             8606
Studies included were meta-analyses, system-        8        3 or 4 or 5                                                            57,016
atic reviews, randomized controlled trials, sur-    9        7 and 8                                                                  252
veys, prospective and retrospective compara-
tive studies, case series and conference
abstracts. We excluded basic science and bio-
mechanical research and studies where the
brace brand was not specified (Figure 1).
Studies that were not published in English and
studies that could not be retrieved were also
excluded.

Data abstraction
  Important characteristics from each includ-
ed study were abstracted to understand the
characteristics of the literature. These vari-
ables included the year of publication, the geo-
graphic region where the study was conducted,
study design, study perspective, outcomes
assessed, and the model and manufacturer of
the brace examined.

Data analysis
   Descriptive statistics were used to summa-
rize all data. Counts, proportions and percent-
ages were used to describe all data. Knee brace
manufacturers and models within the litera-
ture were represented by the number of arti-
cles that each manufacturer/model was exam-
ined in. A manufacturer can only be referenced
once in each article, however within a given
article a manufacturer may have several mod-
els referenced.
   Studies were classified by level of evidence.
Level I evidence is high quality randomized
controlled trials and systematic reviews of ran-
domized controlled trials. Level II evidence
includes lower quality randomized controlled
trials, prospective comparative studies, and
systematic reviews of level II evidence. Level
III evidence consists of retrospective compara-
tive studies and level IV evidence includes case
studies. Level V evidence consists of opinion
                                                    Figure 1. Literature search results.
pieces.10,11

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brand was not specified (88), the article could
not be located (11), and biomechanical studies
(17). Therefore, 50 studies involving the use of
bracing for the treatment of knee OA were
included in this scoping review (Figure 1).

Study design and characteristics
   The majority of studies were conducted in
the United States (58%), with fewer studies
conducted in Canada (8%) and the United
Kingdom (8%) (Figure 2A). While the earliest
article involving bracing for the treatment of
knee OA where a brand was specified was pub-
lished in 1986, half (50%) of all publications
have been published between 2010 and 2014
(Figure 2B). The most prevalent type of study
were prospective comparative studies (44%),
followed by prospective case series (20%) and
narrative reviews (12%) (Figure 2C). These
studies were predominantly level II (44%) evi-
dence and level IV (28%) evidence. Very few
level I studies were identified (6%) (Figure
2D). The majority of the published articles
demonstrated a positive effect of bracing
(92%), with 3 articles (6.0%) showing no
effect of bracing, and only one study (2.0%)
claiming a negative effect of bracing.
Comparison of bracing manufacturers
and models
   When comparing all brace manufacturers,
ÖssurTM (Reykjavík, Island) had the most mod-
els evaluated in the published literature (8),
followed by DonJoy (DJO, Vista, CA, USA; 7
                                                   Figure 2. Study characteristics: A) location of studies; B) year of publication; C) study
models), Breg Inc.TM (Carlsbad, CA, USA; 5         design; D) level of evidence (N=50).
models), and BledsoeTM (Carlsbad, CA, USA; 4
models) (Table 2).
   Similarly, the most commonly evaluated
brace manufacturer was Össur (27 articles),
followed by DonJoy (17 articles), and Breg (11
articles) (Table 2). Across the 14 manufactur-
ers, 36 models were examined in the litera-
ture, of which the models evaluated most fre-
quently were the OAdjuster (DonJoy; 13 arti-
cles), the Generation II (Össur; 10 articles),
Unloader (Össur; 9 articles), OAsys (Össur; 8
articles), Unloader ADJ (Össur; 8 articles), and
OA Defiance (DonJoy; 7 articles) (Table 2).
Between the years of 2010-2014, Össur braces
were most commonly evaluated in the litera-
ture (11 articles), followed by DonJoy (10 arti-
cles) and Breg (6 articles) (Figure 3).
   Two manufacturers had level I studies with-
in the literature; Össur (2 studies) and
Cropper Medical Inc. (Ashland, OR, USA; 1
study) (Table 3). Össur had the most level II
studies (8 studies) followed by DonJoy (7 stud-
ies). The brace models that were evaluated in
level I studies were the Generation II (Össur),
the OAsys (Össur) and the Bioskin Q (Cropper
Medical) (Figure 4). The brace most refer-
enced in level II studies was the OAdjuster
(DonJoy; 6 studies), followed by the Unloader      Figure 3. Number of references for the 5 most referenced bracing manufacturers over
                                                   time.
(Össur; 3 studies). The manufacturer with the

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Review

Table 2. Knee brace manufacturers and models.
Manufacturer                                                       Articles referenced*                                    Model                                             Articles referenced*
Össur (Reykjavík, Island)                                                         27                                       Generation II                                                 10
                                                                                                                           Unloader                                                       9
                                                                                                                           OAsys                                                          8
                                                                                                                           Unloader ADJ                                                   8
                                                                                                                           Unloader One                                                   5
                                                                                                                           Unloader Select                                                5
                                                                                                                           Unloader Spirit                                                4
                                                                                                                           Unloader Express                                               1
DonJoy (Vista, CA, USA)                                                           17                                       OAdjuster                                                     13
                                                                                                                           OA Defiance                                                    7
                                                                                                                           Monarch                                                        3
                                                                                                                           On-Track                                                       2
                                                                                                                           Montana                                                        1
                                                                                                                           OA Lite                                                        1
                                                                                                                           OA Nano                                                        1
Breg (Carlsbad, CA, USA)                                                          11                                       Counter Force                                                  5
                                                                                                                           Tradition X2K                                                  3
                                                                                                                           Fusion OA                                                      2
                                                                                                                           Patellar Tracking Orthosis                                     2
                                                                                                                           Tradition                                                      1
Bauerfeind (Zeulenroda, Germany)                                                  8                                        MOS Genu                                                       6
                                                                                                                           Softec OA                                                      5
Bledsoe (Carlsbad, CA, USA)                                                       8                                        Thruster 2                                                     5
                                                                                                                           Thruster                                                       4
                                                                                                                           Legacy Thruster                                                1
                                                                                                                           DUO                                                            1
Otto Bock (Duderstadt, Germany)                                                   4                                        Genu Arthro                                                    4
Big Sky Medical (Missoula, MT, USA)                                               3                                        Custom Unloader                                                3
VQ OrthoCare (Irvine, CA, USA)                                                    2                                        Free Stride                                                    1
                                                                                                                           OActive                                                        1
Cropper Medical (Ashland, OR, USA)                                                1                                        Bioskin Q                                                      1
Camp Healthcare (Jackson, MI, USA)                                                1                                        Bilateral B1                                                   1
Ongoing Care Solutions (Pinellas Park, FL, USA)                                   1                                        Orthopro OA                                                    1
Proteor (Dijon Cedex, France)                                                     1                                        ODRA                                                           1
St. Clare Engineering Ltd (Eastleigh, UK)                                         1                                        TVS                                                            1
* The number of articles for each manufacturer does not equal the total of all articles for models of that manufacturer as multiple models could be mentioned within the same article.

Table 3. Number of brace models by hinge type and manufacturer.
                              Dual hinge push                Single hinge push                Single hinge pull Patellofemoral Dual hinge distraction                                           Total
Össur                                      1                             0                                 7                           0                                 0                        8
DonJoy                                    4                              2                                 0                           1                                 0                        7
Breg                                      4                              0                                 0                           1                                 0                        5
Bledsoe                                   1                              3                                 0                           0                                 0                       4
Bauerfeind                                1                              1                                 0                           0                                 0                       2
VQ OrthoCare                              0                              2                                 0                           0                                 0                        2
Otto Bock                                 0                              1                                 0                           0                                 0                        1
Big Sky Medical                           0                              1                                 0                           0                                 0                       1
Cropper Medical                            0                             0                                 0                           1                                 0                        1
Camp Healthcare                           1                              0                                 0                           0                                 0                        1
Ongoing Care Solutions                    1                              0                                 0                           0                                 0                       1
Proteor                                   0                              0                                 0                           0                                 1                       1
St. Clare Engineering Ltd.                0                              0                                 1                           0                                 0                       1
Total                                     13                             10                                8                           3                                 1                       35

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most studies with a positive outcome was
Össur (25 studies), followed by DonJoy (17
studies) and Breg (11 articles) (Figure 5).
Comparison of hinge types
   Within the literature the majority of brace
models fall under three types; dual hinge push
(14 models), single hinge push (10 models)
and single hinge pull (8 models) (Table 4). Of
the 14 dual hinge push models, DonJoy and
Breg contribute the most models with 4 each.
Amongst single hinge push models 2 of the 10
models belong to Bledsoe braces, while Össur
braces comprise 7 of the 8 single hinge pull
models.
   The most referenced bracing type is dual
hinge push (52 references), of which 24 refer-
ences (46.1%) belong to DonJoy braces. A com-
plete summary of braces by manufacturer is
provided in Appendix. Single hinge pull braces
are the second most referenced brace type (43
                                                   Figure 4. Level of evidence by bracing model for models with 3 or more articles.
references), with Össur braces comprising 42
(97.8%) of single hinge pull references. The
third most referenced bracing type is single
hinge push braces (26 references) of which 10
references (38.5%) belong to Bledsoe braces.
   When classifying the studies by the level of
evidence for each bracing type, we found that
dual hinge push, single hinge pull and patello-
femoral braces each had one level I study in
the literature. The bracing types with the most
level II evidence were dual hinge push braces
(10 studies), single hinge push braces (9 stud-
ies) and single hinge pull braces (7 studies). A
complete summary of study designs by bracing
type is provided in Appendix.

Discussion
   The purpose of this review was to summa-
rize the literature regarding knee bracing for
                                                   Figure 5. Study outcome by brace manufacturer (n=50).
the treatment of knee OA, and to examine the

Table 4. Number of articles by level of evidence by bracing manufacturer.
Manufacturer                       Level I              Level II             Level III               Level IV                 Level V
Össur                                 2                    8                     5                       6                       6
DonJoy                                0                    7                     4                       3                       3
Breg                                  0                    3                     3                       2                       3
Bauerfeind                            0                    2                     4                       1                       1
Bledsoe                               0                    4                     2                       0                       2
Otto Bock                             0                    1                     2                       0                       1
Big Sky Medical                       0                    0                     1                       1                       1
VQ OrthoCare                          0                    2                     0                       0                       0
Cropper Medical                       1                    0                     0                       0                       0
Camp Healthcare                       0                    1                     0                       0                       0
Ongoing Care Solutions                0                    1                     0                       0                       0
Proteor                               0                    0                     0                       1                       0
TVS                                   0                    0                     0                       1                       0

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Review

representation of different OA knee brace           ing articles published in English may exclude           Technol Assess (Full Rep) 2007:1-157.
manufacturers, models and hinge types within        applicable articles related to bracing for the       2. National Institute for Health and Care
the scientific literature. To accomplish this, a    treatment of knee OA. The final limitation of           Excellence. Osteoarthritis: care and man-
scoping review was performed which, unlike a        this study is that only articles in which a knee        agement. NICE guidelines [CG177].
systematic review, does not evaluate the data       brace model was mentioned were included,                February        2014.    Available      from:
within selected articles but rather evaluates       which resulted in the exclusion of a large              https://www.nice.org.uk/guidance/cg177.
articles to gain an understanding of the char-      amount (88) of articles relevant to knee brac-          Accessed: October 2015.
acteristics of the published literature.12 This     ing for the treatment of knee OA.                    3. Hochberg MC, Altman RD, April KT, et al.
approach also allows for the examination of            Gaps within the current literature identified        American College of Rheumatology 2012
articles that are not randomized controlled tri-    in this scoping review are a lack of high quality       recommendations for the use of nonphar-
als, such as systematic reviews and meta            articles including randomized controlled trials         macologic and pharmacologic therapies in
analyses in order to evaluate the total body of     evaluating the efficacy of knee bracing for the         osteoarthritis of the hand, hip, and knee.
literature associated with a selected topic.        treatment of knee OA. Additionally, few articles        Arthritis Care Res 2012;64:465-74.
   The present scoping review identified 51         comparing hinge type or specific models are          4. Kirkley A, Webster-Bogaert S, Litchfield R,
articles pertaining to the treatment of knee OA     present within the literature in order to show          et al. The effect of bracing on varus
in which the model of knee brace examined is        superiority to one type of brace over others.           gonarthrosis. J Bone Joint Surg Am
specified. The majority of articles examining       Increasing the number of high quality studies,          1999;81A:539-48.
bracing for the treatment of knee OA are pub-       as well as studies comparing brace types (sin-       5. Pollo F, Otis J, Backus S, et al. Reduction of
lished in the United States (58%) between the       gle versus dual hinged; push braces versus pull         medial compartment loads with valgus
years 2010-2014 (50%). Prospective compara-         braces) and models will provide better insight          bracing of the osteoarthritic knee. Am J
tive studies were the most common type of           into the efficacy of specific brace types on the        Sports Med 2002;30:414-21.
study examining knee braces (44%), with very        treatment of knee OA.                                6. Brooks K. Osteoarthritic knee braces on
few randomized controlled trials being con-                                                                 the market: a literature review. J Prosthet
ducted (6%). Articles involving bracing for the                                                             Orthot 2014;26:2-30.
treatment of knee OA generally displayed posi-                                                           7. Feehan N, Trexler G, Barringer W. The
tive outcomes (92%) with only 4 articles indi-      Conclusions                                             effectiveness of off-leading knee orthoses
cating a neutral or negative outcome (8%).                                                                  in reduction of pain in medial compart-
   When examining all knee brace manufactur-           The use of knee braces for the treatment of          ment knee osteoarthritis: a systematic
ers and models, Össur had the most models           knee OA has experienced an increase in the              review. J Prosthet Orthot 2012;24:39-49.
within the literature (22.9% of all models),        number of publications since 2010; however           8. Raja K, Dewan N. Efficacy of knee braces
with DonJoy (20% of all models) and Breg            there is a lack of high quality evidence exam-          and foot orthoses in conservative manage-
(14.3% of all models) following. Össur braces       ining the efficacy of the treatment method.             ment of Kkee osteoarthritis: a systematic
were examined in the most articles (54% of all      Few comparative studies examining differ-               reviw. Am J Phys Med Rehabil 2011;90:
articles), followed by DonJoy (34% of all arti-     ences between hinge types and brace models              247-62.
cles) and Breg (22% of all articles). The most      are also present within the literature. Future       9. Levac D, Colquhoun H, O’Brien KK.
studied type of brace was the dual hinge push       research should aim to evaluate the efficacy of         Scoping studies: advancing the methodol-
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pull braces (33.9% of references).                  quality studies, as well as studies examining       10. Marx R, Wilson S. Updating the assign-
   Strengths of the present study are the wide      differences in performance between different            ment of levels of evidence. J Bone Joint
search strategy that was used to ensure an          bracing types.                                          Surg Am 2015;97A:1-2.
accurate overview of the literature available                                                           11. DeVries J, Berlet G. Understanding levels
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                                                      [Orthopedic Reviews 2016; 8:6256]                                                      [page 55]
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Orthopedic Reviews 2016; volume 8:6303

Levels of evidence in the treat-                   frequency to Caucasians is highest with
                                                   Polynesians (5.6:1), Blacks (3.9:1) and               Correspondence: Andrew Moriarity, St. James’s
ment of slipped capital femoral                    Hispanics (2.5:1).1 Delayed diagnosis is              Hospital, James's Street, Dublin 8, Ireland.
epiphysis: a systematic review                     believed to be the most important factor asso-        Tel.: +353.8514.66551.
                                                   ciated with poor outcomes.3,4 Less severe and         E-mail: andrewmoriarity@gmail.com
Andrew Moriarity,1 Jim Kennedy,1                   stable slips have been successfully managed
                                                                                                         Key words: Levels of evidence; systematic review;
Joe Baker,2 Pat Kiely2                             with in situ pinning to protect against further       slipped capital femoral epiphysis; management.
1                                                  displacement. The treatment of high grade
St James’s Hospital, Dublin, 2Our Lady’s
                                                   unstable slips is more controversial with a           Contributions: the authors contributed equally.
Hospital Crumlin, Dublin, Ireland
                                                   recent trend toward surgical hip dislocation
                                                   and reduction of the slip normally with a cor-        Conflict of interest: the authors declare no poten-
                                                   rective femoral osteotomy.5 The residual              tial conflict of interest.
                                                   healed deformity can lead to femoro-acetabu-
Abstract                                           lar impingement (FAI) and eventual degenera-
                                                                                                         Received for publication: 11 November 2015.
                                                                                                         Revision received: 13 February 2016.
                                                   tive osteoarthritis.6,7                               Accepted for publication: 14 April 2016.
   The primary aim of this study was to analyze       The concept of evidence-based medicine
the current level of evidence available on the     (EBM) was first described in the 1980’s as the        This work is licensed under a Creative Commons
surgical management of Slipped Capital             conscientious, explicit, and judicious use of the     Attribution NonCommercial 4.0 License (CC BY-
Femoral Epiphysis (SCFE). Secondary aims           current best evidence in making decisions             NC 4.0).
were to correlate the level of evidence with the   about the care of individual patients.8 The EBM
impact factor of the journal to evaluate the       grading system can be obtained in the Oxford          ©Copyright A. Moriarity et al., 2016
                                                                                                         Licensee PAGEPress, Italy
level of evidence over time, and to evaluate the   Centre for Evidence-Based Medicine (CEBM).9
                                                                                                         Orthopedic Reviews 2016;8:6303
geographic distribution of the studies.            A study gave a level from 1 to 5 on the basis of      doi:10.4081/or.2016.6303
Therapeutic studies published in English           its design and as 1 of 4 different types on the
between January 1991 and August 2014 that          basis of its content. Level 1 is the highest level
reported on SCFE were identified via electron-     of evidence, which includes high quality, ran-
ic search was performed using the databases        domized controlled trials (RCTs); and level 5,       CEBM study types (Table 1) and into treatment
PubMed, EMBASE, and the Cochrane Library.          is the lowest level of evidence, and includes        type. If a study involved multiple treatment
The search terms used included: Slipped capi-      expert opinions. This system is accepted and         types it was placed in category that the majori-
tal femoral epiphyses OR SCFE OR Slipped           used by most of the medical world including          ty of the study involved. If the abstract did not
upper femoral epiphyses OR SUFE AND                most orthopedic journals.                            provide enough information for classification
Management OR Treatment. Correlation                  Despite the importance of SCFE, to our            then the full text was obtained (n=128). Once
between the level of evidence and the impact       knowledge there are few studies that explore         the decision was made to include the manu-
factor of the journal were analyzed together       the surgical management of the condition, and        script for further analysis then authorship and
with linear regression models to reveal any        even fewer that are of a high level of evidence.     journal of publication were assessed. Any dis-
significant trends over time. A total of 1516      The aim of this study is to review the available     agreements between reviewers were resolved
studies were found, of which 321 were includ-      studies on surgical management of SCFE and           by discussion. The senior author was consult-
ed in the final analysis. The most frequent        to categorize them by study type and level of        ed if a consensus could not be reached at any
study type was the case series (51.1%) fol-        evidence as proposed by the Oxford CEBM.             stage of the analysis and categorization.
lowed by case reports (22.4%) and expert opin-
ion (14.0%). Randomized control trial account-                                                          Inclusion and exclusion criteria
ed for only 0.6%. The Journal of Pediatric                                                                 We included all studies in English that had a
Orthopedics (American) had the most studies        Materials and Methods                                primary emphasis on the therapeutic manage-
(22.6%) and the highest number of level 2                                                               ment of SCFE. Prognostic and diagnostic stud-
(n=1) and level 3 (n=15) type evidence. There         This review adheres to the methodology set        ies were included if they defined the relation-
was no progression of level of evidence over       down in the Preferred Reporting Items for            ship between the treatment and the clinical
time. There was no correlation between level       Systematic reviews and Meta-analyses guide-          outcomes. Studies that reported solely on out-
of evidence and impact factor of journal. The      lines and the Cochrane handbook.10                   comes (e.g. CT evaluation of screw position)
majority of therapeutic studies on SCFE are of        A systematic electronic search was per-           without clinical correlation were excluded.
low level of evidence. High-level RCTs are dif-    formed using PubMed (Medline), EMBASE,               Reviews including systematic reviews were
ficult to perform in pediatric orthopedic sur-     and the Cochrane Library. Studies published          excluded if they did not primarily report on the
gery, however the management of SCFE would         from January 1st, 1991 to August 1st 2014 were       management of SCFE. Studies involving
benefit from well-designed, multicenter, clini-    included. The following search terms were            patients with genetic or metabolic distur-
cal RCTs to advance evidence-based practice.       used: Slipped capital femoral epiphyses OR           bances associated with SCFE were excluded.
                                                   SCFE OR Slipped upper femoral epiphyses OR           Studies on animals, anesthesia and analgesia,
                                                   SUFE AND Management OR Treatment. Only               biology and histology, cadavers, diagnostic
                                                   papers written in English were included.             tools, economics, epidemiology, imaging
Introduction                                                                                            results without clinical outcome, rehabilitation
                                                   Study selection                                      protocols, revision surgery, and surgery for
   Slipped capital femoral epiphysis (SCFE) is       The first two authors sorted the studies           long term complications such as hip arthro-
the most common hip disorder affecting ado-        based on abstracts from the electronic search.       plasty for osteoarthritis were excluded.
lescents with an estimated incidence of            Each author sorted through the databases,            Furthermore, editorials, letters, notes, pro-
between 1 to 24.6 per 100,000 children             which was then validated by the other author.        ceedings, and conference abstracts were also
between the ages of 8 and 15.1,2 The relative      The included studies were then sorted into           excluded.

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Orthopedic reviews open access journal - eISSN 2035-8164 ı ISSN 2035-8237 ı www.pagepress.org/or
Case Report

Data selection
   A database was created using Microsoft
Access (v. 2010, Microsoft). The data extracted
from the reviewed papers included: title,
author, year, journal, volume, issue, pages,
ISSN, abstract, database provider, category,
study type, level of evidence, and country. All
higher-level studies [RCT and systematic
review (SR)] had a deeper analysis performed.
The RCT was ranked level 2 if it had lesser
quality with regards to follow up, randomiza-
tion and blinding. Level of evidence of the
studies determined the SR level. General
reviews were classified as expert opinions
(level 5) as they do not meet the Cochrane cri-
teria of a systematic review. The level of evi-
dence attributed to the study by the publishing
journal was reviewed and in any cases of dis-
crepancy the researchers’ assessment was
used.

Synthesis of results
   Statistical analysis was performed using
Stata (StataCorp. 2009. Stata Statistical
Software: Release 11. College Station, TX:
StataCorp LP). Peason correlation coefficients
were calculated between the mean level of evi-
dence and impact factor of journals that had 10
or more articles included.

                                                   Figure 1. Flow diagram of the literature search progression.
Results
   The electronic search yielded a total of 1516
results from the Medline (n=810), EMBASE
                                                   Table 1. Frequencies of the included studies.
(n=698) and Cochrane databases (n=8). A
total of 610 duplicate articles were removed: 8    Study type                                     N.               %
were from PubMed; 602 were from EMBASE.
                                                   Case series                                   164              51.1
Of the remaining 906 records, 452 were
removed following screening of the abstracts       Case report                                    72              22.4
leaving a total of 454 records. Of records, 133    Expert opinion                                 45              14.0
were screened, based on the full text for a        Comparative study (retrospective)              23               7.2
remaining 321 records, of which 307 were           Systematic review                               5               1.6
from PubMed, 12 were EMBASE and 2 from the         Comparative study (prospective)                 4              1.2
Cochrane library (Figure 1).
                                                   Case control                                    4               1.2
Characteristics of studies                         Randomized control trial                       2               0.6
   The most frequent study type was the case       Economic and decision analysis                  2              0.6
series (n=164; 51.1%) followed by case reports
(n=72; 22.4%). The results from categoriza-
tion are shown in Table 1. The most frequent
level of evidence was type 4 (n=166; 51.7%)
and results of the level of evidence classifica-   Table 2. Distribution of level of evidence.
tion are shown in Table 2. The level 2 evidence
studies were both RCTs (n=2; 100%).                Level of evidence                             N.               %
   The top 8 journals by number of publications    1                                              0                 0
represented 63.9% of all studies (Table 3). The
                                                   2                                              2                0.6
Journal of Pediatric Orthopaedics (JPO), The
Journal of Pediatric orthopaedics B (JPOB)         3                                             36               11.2
and Clinical Orthopaedics and Related              4                                             166              51.7
Research (CORR) had the most number of             5                                             117              36.4

                                                       [Orthopedic Reviews 2016; 8:6303]                                 [page 57]
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Case Report

Table 3. Frequency and distribution of level of evidence in the top 8 journals. Total % is calculated as a percentage of the total amount
of studies. The level of evidence % is calculated as a percentage of the corresponding journal’s studies.
 Journal                  Impact factor                      Level of evidence                                                                                Total
                                                            1               2                     3                   4                       5
                                                     N.         %      N.      %             N.       %         N.         %           N.         %      N.           %
JPO                             1.5                                      1        1.4      15         20.2      55         74.3         3          4.1    74          22.6
JPO-B                           0.6                                                4      10.0         20      50.0         16         40.0        40    12.2
Clin Orthop Relat Res           2.8                                      1        2.8       4         11.1      23         63.9         8         22.2    36          11.0
JBJS - Am                       5.3                                                4      16.0         16      64.0         5          20.0        25    7.6
JBJS - Br                       3.3                                                         6         66.7       3         33.3         9          2.8
Arch Orthop Trauma Surg         1.6                                                2      28.6          2      28.6         3          42.9         7    2.14
Int Orthop                      2.1                                                1      14.2          5      71.4         1          14.2         7    2.14
Orthopedics                     0.9                                                         3         42.9       4         57.1         7         2.14

studies at 46.7% of all studies. JPO had the              Table 4. Distribution of studies by level of evidence and region.
most studies (n=74; 22.6%) and the highest                Region                                             Level of evidence                                Total
number of level 2 (n=1) and level 3 (n=15)                                               1              2            3         4                  5
type evidence. There was no significant corre-
lation between the level of published evidence            N.A                                           2             20          90              77            189
and journal impact factor (Table 3).                      Europe                                                       9          53              12            74
   Over the 23.5-year time period examined,               Asia                                                         2          11              24            37
there has been no change in the mean level of
                                                          Africa                                                                  1                3             4
evidence published. The majority of studies
from 1991 to 2003 were level 4 and 5 case                 Australia                                                   1            4                             5
series/reports (91%) and this remained rela-              S.A.                                                        2            4                             6
tively unchanged by 2014 (87.6%). The geo-                Middle east                                                 2            3               1             6
graphical location of the studies is given in
Table 4. North American journals were noted to
have published 58.9% of the available litera-             inherent in the surgical management of chil-            Zaidi and colleagues and Obremskey and col-
ture within the reference period, 23.1% of pub-           dren. When examining our findings in the con-           leagues both proposed that a level-4 study such
lications originated from Europe and 11.5%                text of other similar studies our results do not        as a retrospective case series could become a
from Asia with the remaining publications                 stand in isolation. Ostlie and colleagues               level 3 study with an historical control
equally distributed across Africa, Australia and          reported that RCTs represented only 0.05% of            group.13,19 Level 4 studies can provide valuable
the Middle East.                                          all pediatric general surgery studies in the past       information for patient management if they
   The largest amounts of studies examining               decade.11 Within the broader orthopedic litera-         are well designed, this includes a prospective,
the surgical treatment options in SCFE were               ture therapeutic studies with level 4 and 5 evi-        homogenous patient population, strict inclu-
those involving the use of single percutaneous            dence are the most common orthopedic stud-              sion and exclusion criteria, standardized treat-
in situ screws. Most of the studies were level 4          ies reported in the literature.12-14 Cashin and         ment protocol, close patient follow up and pre-
(n=55) followed by level 3 (n=12) and level 2             colleagues examined all available studies pub-          determined outcome measures.13
(n=1) evidence as displayed in Table 5.                   lished in JPO, JPO-B and The Journal of                    Our finding of no progression of evidence
                                                          Children’s Orthopaedics over a four year peri-          within the field of SCFE treatment over the ref-
                                                          od and determined that evidence graded level 1          erence period is not consistent with the broad-
                                                          and 2 made up 8% of the literature while level          er orthopedic literature. Fu and colleagues
Discussion and Conclusions                                4 studies were again the majority at 58%.15             reviewed all publications pertaining to anteri-
                                                             We agree that the high proportion of level 4         or cruciate ligament reconstruction (ACL) over
   The aim of this study was to evaluate the              and 5 studies in part are due to the ethical bar-       a twenty-year period and found a steady pro-
quality of evidence in the surgical manage-               riers limiting the use of placebo procedures in         gression in the quality of evidence over that
ment of SCFE. Our review identified 321                   surgical research.16,17 Given the relative rarity       time (REF).20 Zaidi and colleagues reviewed
papers reporting the clinical outcomes of                 of the condition we agree that cohort studies           the levels of evidence of all foot and ankle arti-
SCFE. Disappointingly, but perhaps not unsur-             and case reports are easier to perform, cheap-          cles from the journals Foot & Ankle
prisingly, there were no published studies con-           er, and less time consuming than RCTs.18                International, Foot and Ankle Surgery and the
taining level 1 evidence and there were only 2            Furthermore, RCTs are difficult to facilitate           Journal of Bone and Joint Surgery (American
studies which provided level 2 evidence.                  due to dispersion of cases through a large              and British Volumes) and found a trend
Furthermore, most of the studies examining                number of centers with incumbent the varia-             towards higher levels of evidence from 2000 to
specific surgical treatment options involved              tion of patient presentation, and treatment by          2010 but that the proportion of low levels of
single percutaneous screw fixation and were               individual surgeons.17                                  evidence (Level 3-4) articles remained close to
of level 4 evidence. We do not feel that this lack           Improving the level of evidence in a number          90%.19 Cashin and colleagues noted a slight
of high quality evidence reflects a lack of               of the level 4 studies we reviewed, could have          increase in level 3 pediatric orthopedic related
respect in this condition, but instead high-              been achieved by performing the study                   articles from 2003 to 2008 in JPO and JPO-B.15
lights the practical and ethical challenges               prospectively and utilizing a control group.            We accept that establishing statistically signif-

[page 58]                                                   [Orthopedic Reviews 2016; 8:6303]
Case Report

icant correlation between time and evidence          lished in a particular journal indexed in the     studies on SCFE. This is likely due to the
grade for SCFE treatment may hampered lower          Journal Citation Reports. Impact factor is the    paucity of high-level studies to establish a sig-
number of publications in the field, but we feel     most commonly used tool for the reader to         nificant correlation. Articles pertaining SCFE
that a strong correlation, if present, would be      determine if scientific studies published with-   are not widely cited within the broader ortho-
demonstrated in the 326 papers identified.           in a journal are widely accepted. We could find   pedic literature and would not be a great influ-
   Impact factor is a measure of the average         no correlation between the impact factor of a     ence on impact factor.
number of citations to recent articles pub-          journal and the level of evidence of individual      While we found that the majority of studies

Table 5. Level of evidence and number of studies supporting each surgical treatment option in the management of slipped capital
femoral epiphysis.
Treatment                                                                                                  Level                        Studies
Percutaneous in situ screw fixation (single)                                                                 2                              1
Percutaneous in situ screw fixation (single - prophylactic contralateral hip)                                2                              1
Percutaneous in situ screw fixation (single)                                                                 3                             12
Percutaneous in situ screw fixation (single vs multiple)                                                     3                             4
Percutaneous in situ screw fixation (single vs staged flexion intertrochanteric femoral osteotomy)           3                             4
Percutaneous in situ screw fixation (single vs multiple not specified)                                       3                              4
Intertrochanteric versus subcapital osteotomy                                                                3                              2
Intertrochanteric femoral osteotomy                                                                          3                              2
Percutaneous in situ screw fixation (single +/- manipulation)                                                3                             1
Percutaneous in situ screw fixation vs K-wires                                                               3                              1
Percutaneous in situ screw fixation (single +/- anchorage device)                                            3                              1
Modified osteotomy of Dunn-Fish vs osteotomy of Imhauser                                                     3                             1
Non-operative (casting)                                                                                      3                             1
Intertrochanteric uniplanar flexion osteotomy vs multiplanar osteotomy                                       3                             1
Extracapsular base of neck osteotomy vs Southwick osteotomy                                                  3                             1
K-wire fixation                                                                                              3                             1
Percutaneous in situ screw fixation (single)                                                                 4                             55
Percutaneous in situ screw fixation (single or multiple)                                                     4                             23
Percutaneous in situ screw fixation (prophylactic contralateral hip)                                         4                             17
Femoral neck osteotomy                                                                                       4                             12
Percutaneous in situ screw fixation (single or multiple +/- manipulation)                                    4                             6
Dunn's Osteotomy                                                                                             4                             6
Percutaneous in situ screw fixation (arthroscopic)                                                           4                              5
Intertrochanteric femoral osteotomy                                                                          4                              5
K-wires                                                                                                      4                              4
Casting and manipulation/reduction                                                                           4                             4
Percutaneous in situ screw fixation vs K-wires                                                               4                              3
Percutaneous in situ screw fixation (single vs femoral osteotomy)                                            4                             3
K-wires with open reduction                                                                                  4                             3
Sugioka's modified Hungria-Kramer intertrochanteric osteotomy                                                4                             2
Closed bone graft epiphysiodesis                                                                             4                             2
Subcapital osteotomy                                                                                         4                             2
Imhauser femoral osteotomy                                                                                   4                             2
TRO (trans-troch rotational osteotomy)                                                                       4                             2
Percutaneous in situ screw fixation +/- casting                                                              4                             1
Steinmann pins                                                                                               4                             1
Intra-articular hip arthrodesis without subtrochanteric osteotomy                                            4                             1
Valgus-flexion intertrochanteric osteotomy                                                                   4                             1
Extracapsular base of neck osteotomy versus and Southwick osteotomy                                          4                             1
Subtrochanteric osteotomy                                                                                    4                             1
Extracapsular vs intracapsular reduction and epiphysiodesis                                                  4                             1
Open bone peg epiphysiodesis                                                                                 4                             1
Sugioka's modified Hungria-Kramer intertrochanteric osteotomy                                                4                             1
Percutaneous, opening wedge subtrochanteric femoral osteotomy                                                4                             1

                                                        [Orthopedic Reviews 2016; 8:6303]                                                   [page 59]
Case Report

originated in North America, we accept that               The delay in diagnosis of slipped capital            Level of evidence in anterior cruciate liga-
limiting our search to the English language               femoral epiphysis: a review of 102                   ment reconstruction research: a systemat-
may introduce bias in our categorization by               patients. HSS J 2005;1:103-6.                        ic review. Am J Sport Med 2013;41:924-34.
not considering the quantity and quality of          5.   Madan SS, Cooper AP, Davies AG, et al. The     13.   Obremskey WT, Pappas N, Attallah-Wasif
research published outside English speaking               treatment of severe slipped capital femoral          E, et al. Level of evidence in orthopaedic
countries. JPO is the leading journal in SCFE             epiphysis via the Ganz surgical dislocation          journals. J Bone Joint Surg Am 2005;87:
publications and accounted for 22.6% of all               and anatomical reduction: a prospective              2632-8.
studies. It also provided 50% of the level 2 and          study. Bone Joint J 2013;95-B:424-9.
                                                                                                         14.   Hanzlik S, Mahabir RC, Baynosa RC, et al.
level 3 studies in the top eight pediatric ortho-    6.   Leunig M, Casillas MM, Hamlet M, et al.
                                                                                                               Levels of evidence in research published
pedic journals.                                           Slipped capital femoral epiphysis: early
   SCFE has potentially life changing implica-                                                                 in the Journal of Bone and Joint Surgery
                                                          mechanical damage to the acetabular car-
tions for patients. This is the first review to           tilage by a prominent femoral metaphysis.            (American volume) over the last thirty
examine critically the quality of evidence avail-         Acta Orthop Scand 2000;71:370-5.                     years. J Bone Joint Surg Am 2009;91:425-
able to aid in treatment decisions. It highlights    7.   Beck M, Kalhor M, Leunig M, et al. Hip               8.
the paucity of high-level evidence available to           morphology influences the pattern of dam-      15.   Cashin MS, Kelley SP, Douziech JR, et al.
guide those, treating this challenging problem.           age to the acetabular cartilage: femoroac-           The levels of evidence in pediatric
We hope that this work will provide motivation            etabular impingement as a cause of early             orthopaedic journals: where are we now? J
for further considered and ethical study on this          osteoarthritis of the hip. J Bone Joint Surg         Pediatr Orthoped 2011;31:721-5.
important and challenging topic.                          Br 2005;87:1012-8.                             16.   Meakins JL. Innovation in surgery: the
                                                     8.   Sackett DL, Rosenberg WMC, Gray JAM, et              rules of evidence. Am J Surg 2002;183:399-
                                                          al. Evidence based medicine: what it is and          405.
                                                          what it isn’t. Brit Med J 1996;312:71-2.       17.   Stirrat GM. Ethics and evidence based sur-
References                                           9.   OCEBM Levels of Evidence Working                     gery. J Med Ethics 2004;30:160-5.
                                                          Group. The Oxford Levels of Evidence 2.        18.   Brubaker L, Moalli P, Richter HE, et al.
 1. Loder RT, Skopelja EN. The epidemiology               Oxford Centre for Evidence-Based                     Challenges in designing a pragmatic clini-
    and demographics of slipped capital                   Medicine. 2014. Available from:
                                                                                                               cal trial: the mixed incontinence - medical
    femoral epiphysis. ISRN Orthop                        http://www.cebm.net
                                                                                                               or surgical approach (MIMOSA) trial expe-
    2011;2011:486512.                               10.   Moher D, Liberati A, Tetzlaff J, et al.
                                                          Preferred reporting items for systematic             rience. Clin Trials 2009;6:355-64.
 2. Larson AN, Yu EM, Melton LJ, et al.
    Incidence of slipped capital femoral epiph-           reviews and meta-analyses: the PRISMA          19.   Zaidi R, Abbassian A, Cro S, et al. Levels of
    ysis: a population-based study. J Pediatr             statement. Ann Intern Med 2009;151:264-              evidence in foot and ankle surgery litera-
    Orthop B 2010;19:9-12.                                9.                                                   ture: progress from 2000 to 2010? J Bone
 3. Kocher MS, Bishop JA, Weed B, et al. Delay      11.   Ostlie DJ, St Peter SD. The current state of         Joint Surg Am 2012;94:e1121-10.
    in diagnosis of slipped capital femoral epi-          evidence-based pediatric surgery. J            20.   Fu FH, Schulte KR. Anterior cruciate liga-
    physis. Pediatrics 2004;113:e322-5.                   Pediatr Surg 2010;45:1940-6.                         ment surgery 1996. State of the art? Clin
 4. Green DW, Reynolds RAK, Khan SN, et al.         12.   Samuelsson K, Desai N, McNair E, et al.              Orthop Relat Res 1996;325:19-24.

[page 60]                                             [Orthopedic Reviews 2016; 8:6303]
Orthopedic Reviews 2016; volume 8:6357

Heel ultrasound scan                                quence of interaction of lifetime behavioural
                                                    and genetic factors. Osteoporosis has a signif-       Correspondence: Faiz R. Hashmi, Trauma and
in detecting osteoporosis                           icant impact on the economy worldwide. In the         Orthopedic Surgery, Warwick Hospital, Larkin
in low trauma fracture patients                     UK, it is estimated that osteoporosis is costing      road, Warwickshire CV34 5BW, UK.
                                                    the Government about five million pounds              Tel.: +44.0797.7268004 - Fax: +44.01926.482651.
                                                                                                          E-mail: hashmi@btinternet.com
Faiz R. Hashmi,1 Khaled O. Elfandi2                 daily.3 In the United States, the spending on
1Department of Trauma and Orthopedic                osteoporosis is about seventeen billion dollars       Key words: Osteoporosis; central bone density;
                                                    annually.4                                            quantitative ultrasound; bone mineral density.
Surgery, South Warwickshire Hospitals
NHS Foundation Trust, Warwick;
2
  Department of General Medicine,
                                                    Objective                                             Contributions: FRH, acquisition of data, concep-
                                                       The aim of this study was to find out              tion, study design, drafting the article; KOE
Solihull Hospital, UK                                                                                     acquisition of data, conception, analysis of data,
                                                    whether heel ultrasound is as good as central
                                                                                                          drafting the article.
                                                    bone densitometry scanning in diagnosing
                                                    osteoporosis in patients who are at high risk of      Conflict of interest: the authors declare no poten-
                                                    osteoporosis. Previous studies mainly com-            tial conflict of interest.
Abstract                                            pared heel ultrasound and central bone densit-
                                                    ometry scanning (DEXA) in screening purpos-           Received for publication: 9 December 2015.
   Osteoporosis is the most common metabolic        es, and inclusion of high risk patients for           Accepted for publication: 16 May 2016.
disease with significant impact on the morbid-      osteoporosis to our knowledge, has not been
ity and mortality of affected patients.                                                                   This work is licensed under a Creative Commons
                                                    done previously.
                                                                                                          Attribution NonCommercial 4.0 License (CC BY-
Osteoporosis has a significant impact on the
                                                                                                          NC 4.0).
economy worldwide. The aim of this study was
to find out whether heel ultrasound is as good                                                            ©Copyright F.R. Hashmi and K.O. Elfandi, 2016
as central bone densitometry scanning in diag-      Materials and Methods                                 Licensee PAGEPress, Italy
nosing osteoporosis in patients who are at                                                                Orthopedic Reviews 2016;8:6357
high risk of osteoporosis. This was a prospec-         This was a prospective study of patients           doi:10.4081/or.2016.6357
tive study of patients comparing heel ultra-        comparing heel ultrasound to central bone
sound to central bone densitometry scanning         DEXA in patients who presented to the
(dual X-ray absorptiometry, DEXA) in patients.      Accident & Emergency Department of
The recruited patients attended for a DEXA                                                               and negative predictive values were 60%
                                                    Birmingham Heartlands Hospital NHS Trust
scan of the left hip and lumbar spine. All sub-                                                          (95%CI: 35-85) and 82% (95%CI: 70-93). The
                                                    (now called the Heart Of England NHS
jects had an ultrasound of the left heel using                                                           likelihood ratios for positive and negative test
                                                    Foundation Trust), with a low trauma fracture.
the quantitative heel ultrasound machine. The                                                            results were 3.7 (95%CI: 1.6-8.8) and 0.55
                                                       Patients were recruited from the Accident
results of DEXA scan were blinded from the                                                               (95%CI: 0.33-0.92) respectively (Tables 2 and
                                                    and Emergency Department of Birmingham
results of ultrasound and vice versa. There                                                              3). A positive ultrasound heel test raised the
                                                    Heartlands Hospital, who presented with low
were 59 patients who took part in the study, 12                                                          pre-test probability of 28% to a post-test proba-
                                                    trauma fractures over an eight month period.
men and 47 women. The mean age was 66               The recruited patients attended for a DEXA           bility of 60%. A negative ultrasound heel test
years (SD 11.9) and mean weight was 62.5 kg         scan of the left hip and lumbar spine at Solihull    lowered the pre-test probability from 28% to a
(SD 10.7). The sensitivity and specificity of the   Hospital. The test results are computer gener-       post-test probability of 18%.
ultrasound heel test to predict osteoporosis        ated and analyzed using WHO criteria for the            Specificity for predicting BMD-defined
were 53% (95%CI: 29-77) and 86% (95%CI: 75-         diagnosis of osteoporosis. All subjects had an       osteoporosis was high (86%), but sensitivity
96) respectively. Specificity for predicting bone   ultrasound of the left heel using the                was low (53%). A Heel Ultrasound result in the
mineral density (BMD)-defined osteoporosis          Quantitative Heel Ultrasound machine (QUS-           osteoporotic range was highly predictive of
was high (86%), but sensitivity was low (53%).      2). The results of DEXA scan were blinded from       BMD-defined osteoporosis. On the other hand
A heel ultrasound result in the osteoporotic        the results of ultrasound and vice versa. The        a Heel Ultrasound result in the normal range
range was highly predictive of BMD-defined          accuracy was presented as sensitivity, speci-        (i.e. no osteoporosis) lowered the per-test
osteoporosis. A positive ultrasound heel test in    ficity, predictive value and likelihood ratio. I     probability from 28% to a post-test probability
high risk patients is more useful in ruling in      have also estimated post-test probability of         of 18%. A positive ultrasound heel test in high
osteoporosis than a negative test to rule out       having osteoporosis for the study population         risk patients is more useful in ruling in osteo-
osteoporosis.                                       depending on whether the test result was pos-        porosis than a negative test to rule out osteo-
                                                    itive or negative.                                   porosis.

Introduction
                                                    Results                                              Discussion and Conclusions
   Osteoporosis is the most common metabolic
disease with significant impact on the morbid-         There were 59 patients who took part in the          Osteoporosis prevalence in developed coun-
ity and mortality of affected patients.1            study, 12 men and 47 women. The mean age             tries is very high and is increasing especially
Osteoporosis defined by the World Health            was 66 years (SD 11.9) and mean weight was           with increasing age and decrease physical
Organization is a condition in which bone           62.5 kg (SD 10.7). Of the 59 patients, 17 (28%)      activity.
mineral density is less than 2.5 standard devi-     had osteoporosis (Table 1). The sensitivity and         In the UK, NICE guideline recommend pro-
ation below the average density in gender           specificity of the ultrasound heel test to predict   phylactic use of antiosteoporotic medication in
matched young adults.2 It affects both men and      osteoporosis were 53% (95%CI: 29-77) and             high risk patients especially with low impact
women at different stages of life, as a conse-      86% (95%CI: 75-96) respectively. The positive        fractures. The cast and unnecessary intake of

                                                      [Orthopedic Reviews 2016; 8:6357]                                                          [page 61]
Article

medication in normal population has                                                         of WHO BMD definitions. It found BUA (Broad
                                                                           have results in the normal range (osteoporosis
increased the financial burden on NHS which                                could fairly confidently be ruled out, with a
                                                                                            band ultrasound attenuation) and VOS
is already struggling.                                                     post-test probability 18%). However, there
                                                                                            (Velocity of sound) to have higher sensitivities
   The use of Quantitative ultrasound in this                              would be a degree of uncertainty about the
                                                                                            of 77% and 69%, respectively for diagnosing
high risk group will detect patients with osteo-                           remaining 13.5%, who would then need a
                                                                                            osteoporosis in 100 women aged 60-69 years.8
porosis who can start medication and the                                   DEXA scan to identify those with osteoporosis.
                                                                                            These higher sensitivities may have been due
remaining patients can be discharged safely.                                  Previous studies of Heel Ultrasound as a
                                                                                            to use of higher BUA and VOS cut-off values.
   In the light of the pilot Heel Ultrasound                               predictor of BMD have generally used conven-
                                                                                            As expected, specificities were lower than in
study, how can one interpret Heel Ultrasound                               tional sensitivity and specificity analyses only,
                                                                                            the above pilot study.
results? If a Heel Ultrasound result is normal                             not LRs, and have not used the WHO BMD def-
                                                                                               There is no consensus on what cut-off val-
or negative for osteoporosis, it becomes more                              initions. For example, two community-based
                                                                                            ues to use with QUS to diagnose osteoporosis.
useful in ruling out osteoporosis as it has a                              cross-sectional studies on 700 post-
                                                                                            It was found that changing the cut-off could
predictive value of 82% and LR of 0.55 (95%CI:                             menopausal,5 and 1000 peri-menopausal
                                                                                            achieve higher sensitivity, but only by accept-
0.33-0.92). Therefore, if Heel Ultrasound scans                            women respectively,6 found that there was a
                                                                                            ing higher rates of false positives (lower speci-
were performed on a population similar to the                              40-50% overlap in the number of women in the
                                                                                            ficity) and less discriminating likelihood
pilot study population (28% prevalence of                                  lowest quartile of both DEXA and Heel
                                                                                            ratios.
osteoporosis) as all of them are high risk                                 Ultrasound measurements. Two other studies
                                                                                               Quantitative ultrasound has proven to be a
patients having presented with low trauma                                  found Heel Ultrasound parameters to have a
                                                                                            good predictor of fracture risk in several stud-
fractures. Then 15.2% would have a Heel                                    sensitivity of 65-70% for BMD in the lowest
                                                                                            ies.9 In a large prospective study of 6189 post-
Ultrasound result in the osteoporotic range                                quartile.7 Only one study other than this pilot
                                                                                            menopausal women over age 65, quantitative
(likely to have osteoporosis) and 61% would                                Heel Ultrasound has evaluated QUS in terms
                                                                                            ultrasonography of the calcaneus predicted hip
                                                                                            fracture as accurately as bone densitometry.10
                                                                                            In a larger study of 14,824 patients that includ-
                                                                                            ed younger women as well as men ages 42 to
                                                                                            82 years, quantitative calcaneal ultrasound
Table 1. Description of demographic characteristic of patients by test results (heel ultra- also was a good predictor of total and hip frac-
sound, HS); 17 patients were positive for osteoporosis defined by dual X-ray absorptiom- ture risk.11 A third study of 2837 women (463
etry scans.                                                                                 ages 20 to 39 years and 2374 ages 55 to 79
Characteristic                HS positive             HS negative           P value         years) found that quantitative ultrasound of
                                                                                            the calcaneus worked as well as central DEXA
DEXA positive                        9                       8                 ≤1           for identification of women at high risk for
Age (years), mean ± SD          70.7±12.1               63.1±14.6             0.076         osteoporotic vertebral fractures.12 In addition
Gender                                                                                      to predicting fracture risk, other studies have
   Male                              0                      12               ≤0.001         found that quantitative ultrasound is at least
   Female                           15                      32               ≤0.001         as good as and possibly better than clinical risk
Ethnicity                                                                                   factors for predicting women at risk for osteo-
   Caucasian                         7                      44               ≤0.001         porosis.13,14
   Asian                             2                       6               ≤0.05             A major limitation to using quantitative
                                                                                            ultrasound as a screening tool is that the crite-
                                                                                            ria for diagnosing osteoporosis and recom-
                                                                                            mending treatment based upon ultrasound are
Table 2. Association between quantitative heel ultrasound (QUS) results and bone min- not yet well established.15 Furthermore, ultra-
eral density by dual X-ray absorptiometry in 59 patients.                                   sound cannot reliably be used to follow women
 QUS result                     Bone mineral density                     Total (n=59)       who are treated for osteoporosis because of
                 Osteoporosis                      No osteoporosis                          limited precision and a slow rate of change of
                                                                                            bone mass at peripheral sites. Thus, most
Positive               9                                   6               15 (25.4%)
                                                                                            women with a high risk ultrasound finding will
Negative               8                                  36               44 (74.6%)       need a confirmatory DEXA both to determine
                                                                                            the need for treatment based upon well estab-
                                                                                            lished guidelines, and as a baseline for moni-
Table 3. Sensitivity and specificity of heel ultrasounds in diagnosing bone mineral den- toring therapy.
sity defined osteoporosis or ruling it out.
                                                                                                                      95% CI
Sensitivity a / (a+c) 53%                                                                                               29-77                  References
Specificity d / (b+d) 86%                                                                                               75-96
                                                                                                                                               1. No authors listed. Consensus development
Pre-test Probability ( Prevalence): (a+c) / (a+b+c+d) 29%                                                               17-40
                                                                                                                                                  conference: diagnosis, prophylaxis, and
Positive Predictive Value: a / (a+b) 60%                                                                                35-85                     treatment of osteoporosis. Am J Med
Negative Predictive Value: d / (c+d) 82%                                                                                70-93                     1993;94:646-50.
Likelihood Ratio + sens / (1-spec) 3.71                                                                               1.56-8.81                2. NIH Consensus Development Panel on
Likelihood Ratio - (1-sens) / spec 0.55                                                                               0.33-0.92                   Osteoporosis Prevention, Diagnosis, and
CI, confidence interval. a, 9 (positive, osteoporosis); b, 6 (positive, no osteoporosis); c, 8 (negative, osteoporosis); d, 36 (negative, no      Therapy. Osteoporosis prevention, diagno-
osteoporosis).                                                                                                                                    sis, and therapy. JAMA 2001;285:785-95.

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