Glo Guideline
Glo Guideline
Glo Guideline
OSTEOARTHRITIS
GUIDELINE AND EVIDENCE REPORT
This guideline and the systematic review upon which it is based were funded exclusively
by the AAOS. All panel members gave full disclosure of conflicts of interest prior to
participating in the development of this guideline. The AAOS received no financial
support from industry or other commercial sponsors to develop this guideline or the
underlying systematic review.
Disclaimer
This Clinical Practice Guideline was developed by an AAOS physician volunteer Work
Group based on a systematic review of the current scientific and clinical information and
accepted approaches to treatment and/or diagnosis. This Clinical Practice Guideline is not
intended to be a fixed protocol, as some patients may require more or less treatment or
different means of diagnosis. Clinical patients may not necessarily be the same as those
found in a clinical trial. Patient care and treatment should always be based on a clinician’s
independent medical judgment, given the individual patient’s clinical circumstances.
Disclosure Requirement
In accordance with AAOS policy, all individuals whose names appear as authors or
contributors to Clinical Practice Guideline filed a disclosure statement as part of the
submission process. All panel members provided full disclosure of potential conflicts of
interest prior to voting on the recommendations contained within this Clinical Practice
Guideline.
Funding Source
This Clinical Practice Guideline was funded exclusively by the American Academy of
Orthopaedic Surgeons who received no funding from outside commercial sources to support
the development of this document.
FDA Clearance
Some drugs or medical devices referenced or described in this Clinical Practice Guideline
may not have been cleared by the Food and Drug Administration (FDA) or may have been
cleared for a specific use only. The FDA has stated that it is the responsibility of the
physician to determine the FDA clearance status of each drug or device he or she wishes to
use in clinical practice.
Copyright
All rights reserved. No part of this Clinical Practice Guideline may be reproduced, stored in a
retrieval system, or transmitted, in any form, or by any means, electronic, mechanical,
photocopying, recording, or otherwise, without prior written permission from the AAOS.
Published 2009 by the American Academy of Orthopaedic Surgeons
6300 North River Road
Rosemont, IL 60018
First Edition
Copyright 2009
by the American Academy of Orthopaedic Surgeons
1. We are unable to recommend for or against physical therapy for the initial
treatment of patients with osteoarthritis of the glenohumeral joint.
Definition: A Limited recommendation means the quality of the supporting evidence that
exists is unconvincing, or that well-conducted studies show little clear advantage to one
approach versus another.
5. We are unable to recommend for or against the use of arthroscopic treatments for
patients with glenohumeral joint osteoarthritis. These treatments include
debridement, capsular release, chondroplasty, microfracture, removal of loose
bodies, and biologic and interpositional grafts, subacromial decompression, distal
clavicle resection, acromioclavicular joint resection, biceps tenotomy or
tenodesis, and labral repair or advancement.
Definition: A Limited recommendation means the quality of the supporting evidence that
exists is unconvincing, or that well-conducted studies show little clear advantage to one
approach versus another.
Definition: A Moderate recommendation means that the benefits exceed the potential
harm (or that the potential harm clearly exceeds the benefits in the case of a negative
recommendation), but the strength of the supporting evidence is not as strong.
10. In the absence of reliable evidence, it is the opinion of this work group that
physicians use peri-operative mechanical and/or chemical VTE (venous
thromboembolism) prophylaxis for shoulder arthroplasty patients.
11. The use of either keeled or pegged all polyethylene cemented glenoid components
are options when performing total shoulder arthroplasty.
Definition: A Limited recommendation means the quality of the supporting evidence that
exists is unconvincing, or that well-conducted studies show little clear advantage to one
approach versus another.
12. In the absence of reliable evidence, it is the opinion of this work group that total
shoulder arthroplasty not be performed in patients with glenohumeral
osteoarthritis who have an irreparable rotator cuff tear.
15. We are unable to recommend for or against a specific type of humeral prosthetic
design or method of fixation when performing shoulder arthroplasty in patients
with glenohumeral joint osteoarthritis.
The following organizations participated in peer review of this clinical practice guideline:
For additional information concerning these processes and a complete list of individuals who
participated in the peer review or public commentary processes of this document, please refer
to the Appendices.
I. INTRODUCTION ........................................................................................... 1
Overview........................................................................................................................................................ 1
Incidence ....................................................................................................................................................... 2
Prevalence ..................................................................................................................................................... 2
Etiology .......................................................................................................................................................... 2
Data Extraction............................................................................................................................................. 6
Public Commentary.....................................................................................................................................12
Recommendation 1 ......................................................................................................................................13
Recommendation 2 ......................................................................................................................................14
Recommendation 3 ......................................................................................................................................15
Recommendation 4 ......................................................................................................................................16
Recommendation 5 ......................................................................................................................................22
Recommendation 6 ......................................................................................................................................23
Recommendation 7 ......................................................................................................................................24
Recommendation 8 ......................................................................................................................................92
Recommendation 9 ....................................................................................................................................118
Recommendation 10 ..................................................................................................................................128
Recommendation 11 ..................................................................................................................................129
Recommendation 12 ..................................................................................................................................139
Recommendation 13 ..................................................................................................................................140
Recommendation 14 ..................................................................................................................................141
Recommendation 16 ..................................................................................................................................143
Appendix I ..................................................................................................................................................147
Appendix II ................................................................................................................................................148
Appendix IV ...............................................................................................................................................153
Appendix V ................................................................................................................................................154
Appendix VI ...............................................................................................................................................155
Appendix X ................................................................................................................................................165
Appendix XI ...............................................................................................................................................167
Appendix IX ...............................................................................................................................................171
This guideline is intended to be used by all appropriately trained surgeons and all
qualified physicians managing the treatment osteoarthritis of the glenohumeral joint. It is
also intended to serve as an information resource for decision makers and developers of
practice guidelines and recommendations.
INTENDED USERS
This guideline is intended to be used by orthopaedic surgeons, all qualified physicians
and/or healthcare professionals managing patients with glenohumeral joint osteoarthritis.
Typically, Orthopaedic surgeons will have completed medical training, a qualified
residency in orthopaedic surgery, and some may have completed additional sub-specialty
training. Insurance payers, governmental bodies, and health-policy decision-makers may
also find this guideline useful as an evolving standard of evidence regarding treatment of
osteoarthritis of the glenohumeral joint.
Treatment for glenohumeral osteoarthritis is based on the assumption that decisions are
predicated on patient and physician mutual communication with discussion of available
treatments and procedures applicable to the individual patient. Once the patient has been
PATIENT POPULATION
This document addresses the treatment of glenohumeral joint osteoarthritis in adults
(defined as patients 19 years of age and older). The guideline provides information on
patient management after diagnosis of osteoarthritis of the glenohumeral joint.
INCIDENCE
The incidence of glenohumeral joint osteoarthritis is more common in women and
appears to increase with age.1
PREVALENCE
Degenerative joint disease of the shoulder is relatively common.2 The shoulder is, after
knee and hip, the third most common joint to require surgical reconstruction.3
BURDEN OF DISEASE
“The estimated annual cost for medical care of arthritis and joint pain for patients with
any diagnosis in 2004 was $281.5 billion dollars. This is an average of $7500 for each of
the 37.6 million persons who reported having arthritis or joint pain.”3
ETIOLOGY
Arthritis of the glenohumeral joint can be the result of primary osteoarthritis, post-
traumatic deformity, inflammatory arthritis, sepsis, or avascular necrosis.4
RISK FACTORS
The risk of shoulder arthritis is increased by a history of injury or surgery to the
shoulder.1
An AAOS Glenohumeral Osteoarthritis physician work group prepared this guideline and
the underlying systematic reviews with the assistance of the AAOS Clinical Practice
Guidelines Unit (Appendix I) in the Department of Research and Scientific Affairs at the
AAOS.
To develop the guideline, the work group met at an introductory meeting on November
22, 2008 to establish the scope of the guideline. Upon completion of the systematic
review, the work group met again on June 27 and 28, 2009 to write and vote on the final
recommendations and rationales for each recommendation. The resulting draft guidelines
were then peer-reviewed, sent for public commentary, and then sequentially approved by
the AAOS Evidence Based Practice Committee, AAOS Guidelines and Technology
Oversight Committee, AAOS Council on Research Quality Assessment and Technology,
and the AAOS Board of Directors (Appendix II).
To be included in our systematic reviews (and hence, in this guideline) an article had to
be a report of a study that:
We also excluded some outcomes from consideration. We did not include surrogate
outcomes. Surrogate outcome measures are laboratory measurements or another physical
sign used as substitutes for a clinically meaningful end point that measures directly how a
patient feels, functions, or survives.9 For a surrogate outcome to be valid it must be in the
causal pathway between intervention and the outcome and it must demonstrate a large,
consistently measurable association with the outcome.9
OUTCOMES CONSIDERED
Clinical studies often report many different outcomes. Again, we included only patient-
oriented outcomes. We did not include surrogate outcomes. Radiographic results and
radiolucency are examples of surrogate outcomes that were not included.
The values for the MCII for the majority of outcomes for glenohumeral joint
osteoarthritis have not been reported in the literature. We could only report the minimally
clinically important difference for the ASES overall score (See Figures 72 and 73; page
96 and 97). For Glenohumeral Joint Osteoarthritis, we were not able to identify any other
MCIIs reported in the literature.
When possible we describe the results of studies using terminology based on that of
Armitage et al.11 The associated descriptive terms we use in this guideline and the
conditions for using each of these terms, are outlined in the following table:
We searched for articles published from January 1966 to June 2009. Strategies for
searching electronic databases were constructed by the AAOS Medical Librarian. The
search strategies we used are provided in Appendix III. We searched six electronic
databases; PubMed, EMBASE, CINAHL, The Cochrane Library, The National
Guidelines Clearinghouse and TRIP database.
The study attrition diagram (Appendix IV) provides details about the inclusion and
exclusion of these studies.
DATA EXTRACTION
Data elements extracted from studies were defined in consultation with the physician
work group. Three analysts completed data extraction independently for all studies. The
work group audited the evidence tables. Disagreements about the accuracy of extracted
data were resolved by consensus and consulting the work group. The elements extracted
are shown in Appendix V.
The AAOS Guidelines Unit constructed evidence tables to summarize the best evidence
pertaining to each preliminary recommendation. These tables are available as a
supplemental document available on the AAOS website
(http://www.aaos.org/research/research.asp). These evidence tables include complete lists
of included and excluded articles, quality and design parameters of the included studies,
and raw data extracted from the included studies.
We assessed the quality of the evidence for each outcome at each time point reported in a
study. We did not simply assess the overall quality of a study. Our approach follows the
recommendations of the Grading of Recommendations, Assessment, Development, and
Evaluation (GRADE) working group12 as well as others.13
We assessed the quality using a two step process. First, we assigned a Level of Evidence
to all results reported in a study based solely on that study’s design. Accordingly, all data
presented in randomized controlled trials were initially categorized as Level I evidence,
all results presented in non-randomized controlled trials and other prospective
comparative studies were initially categorized as Level II, all results presented in
retrospective comparative and case-control studies were initially categorized as Level III,
and all results presented in case-series reports were initially categorized as Level IV (see
Appendix VI). We next assessed each outcome at each reported time point using a quality
questionnaire and, when quality standards were not met, downgraded the Level of
evidence (for this outcome at this time point) by one Level (Appendix VI).
Assigning a Level of Evidence on the basis of study design plus other quality
characteristics ties the Levels of Evidence we report more closely to quality than Levels
of Evidence based only on study design. Because we tie quality to Levels of Evidence,
we are able to characterize the confidence one can have in their results. Accordingly, we
characterize the confidence one can have in Level I evidence as high, the confidence one
can have in Level II and III evidence as moderate, and the confidence one can have in
Level IV and V evidence as low.
The strength of a recommendation expresses the degree of confidence one can have in a
recommendation. As such, the strength expresses how possible it is that a
recommendation will be overturned by future evidence. It is very difficult for future
evidence to overturn a recommendation that is based on many high quality randomized
controlled trials that show a large effect. It is much more likely that future evidence will
overturn recommendations derived from a few small case series. Consequently,
recommendations based on the former kind of evidence are rated as “strong” and
recommendations based on the latter kind of evidence are given strength of
recommendation of “limited”.
1
The AAOS will issue a consensus-based recommendation only when the service in question has virtually no
associated harm and is of low cost (e.g. a history and physical) or when not establishing a recommendation could have
catastrophic consequences.
CONSENSUS DEVELOPMENT
Work group members voted on each recommendation and its strength using a structured
voting technique that was a modification of the Nominal Group Technique (see Appendix
VIII), a method previously used in guideline development.14 Voting on guideline
recommendations was conducted by secret ballot.14 Briefly each member of the guideline
work group ranks his or her agreement with a guideline recommendation or performance
measure on a scale ranging from 1 to 9 (where 1 is “extremely inappropriate” and 9 is
“extremely appropriate”). Consensus is obtained if the number of individuals who do not
rate a measure as 7, 8, or 9 is statistically non-significant (as determined using the
binomial distribution). Because the number of work group members who are allowed to
dissent with the recommendation depends on statistical significance, the number of
permissible dissenters varies with the size of the work group. If disagreements were not
resolved after three voting rounds, no recommendation was adopted. Lack of agreement
can be a reason that the strength of some recommendations may be labeled as
“Inconclusive.”
For this guideline, the work group resolved all disagreements within three voting rounds
and no recommendations were graded as “inconclusive” because of lack of agreement
within the work group. Two consensus based recommendations were issued following the
rules outlined in Appendix VIII.
STATISTICAL METHODS
When possible we report the results of the statistical analyses conducted by the authors of
the included studies. In some circumstances, statistical testing was not conducted;
however, the authors reported sufficient quantitative data, including measures of
dispersion or patient level data for statistical testing. In these circumstances we used the
statistical program STATA (StatCorp LP, College Station, Texas) to conduct our own
analysis to interpret the results of a study. P-values < 0.05 were considered statistically
STATA was also used to determine 95% confidence intervals, using the method of
Wilson, when authors of the included studies reported counts or proportions. The
program was also used to determine the magnitude of the treatment effect. For data
reported as means (and associated measures of dispersion) we calculated a standardized
mean difference by the method of Hedges and Olkin.15 For proportions, we calculated the
odds ratio as a measure of treatment effect.
We used G*Power 3 (Franz Faul, Universitat Kiel, Germany) to determine if a study was
sufficiently powered to detect the MCII. In our power calculations, we used 80% power,
95% confidence intervals, and the number of patients per group. This allowed calculation
of the minimal detectable effect size which was compared to the MCII effect size to
determine if the study had enough power to detect the MCII.
PEER REVIEW
The draft of the guideline and evidence report were peer reviewed by outside specialty
organizations that were nominated by the physician work group prior to the development
of the guideline. Peer review was accomplished using a structured peer review form (see
Appendix IX).
In addition, the physician members of the AAOS Guidelines and Technology Oversight
Committee, the Evidence Based Practice Committee and the Chairpersons of the AAOS
Occupational Health and Workers’ Compensation Committee and the Medical Liability
Committee were given the opportunity to provide peer review of the draft document.
We forwarded the draft guideline to a total of 34 peer reviewers and 17 returned reviews.
The disposition of all non-editorial peer review comments was documented and the
guideline was modified in response to peer review. The peer reviews and the responses to
them accompanied this guideline through the process of public commentary and the
subsequent approval process. Peer reviewing organizations and peer reviewing
individuals are listed in this document if they explicitly agree to allow us to publish this
information (Appendix X).
Peer review of an AAOS guideline does not imply endorsement. This is clearly stated on
the structured review form (Appendix IX) sent to all peer reviewers and is also posted
within the guideline (Appendix X). Endorsement cannot be solicited during the peer
review process because the documents can still undergo substantial change as a result of
both the peer review and public commentary processes. In addition, no guideline can be
endorsed by specialty societies outside of the Academy until the AAOS Board of
Directors has approved it. Organizations that provide peer review of a draft guideline
will be solicited for endorsement once the document has completed the full review and
approval processes.
REVISION PLANS
This guideline represents a cross-sectional view of current treatment and/or diagnosis and
may become outdated as new evidence becomes available. This guideline will be revised
in accordance with this new evidence, changing practice, rapidly emerging treatment
options, and new technology. This guideline will be updated or withdrawn in five years in
accordance with the standards of the National Guideline Clearinghouse.
Shorter versions of the guideline are available in other venues. Publication of most
guidelines is announced by an Academy press release, articles authored by the workgroup
and published in the Journal of the American Academy of Orthopaedic Surgeons, and
articles published in AAOS Now. Most guidelines are also distributed at the AAOS
Annual Meeting in various venues such as on Academy Row and at Committee Scientific
Exhibits.
Selected guidelines are disseminated by webinar, an Online Module for the Orthopeadic
Knowledge Online website, Radio Media Tours, Media Briefings, and by distributing
them at relevant Continuing Medical Education (CME) courses and at the AAOS
Resource Center.
Other dissemination efforts outside the AAOS include submitting the guideline to the
National Guideline Clearinghouse and distributing the guideline at other medical
specialty societies’ meetings.
Rationale:
Despite an exhaustive review of the literature, there was insufficient evidence to make
conclusions either in favor of or against the efficacy of physical therapy. This includes
the modalities of massage, joint mobilization, joint manipulation, exercise, phonophoresis,
iontophoresis, ultrasound, laser, acupuncture, and/or electrical stimulation, in the
treatment of patients with osteoarthritis of the shoulder. Further, no studies of sufficient
quality were found that addressed massage therapy, hydrotherapy, manual therapy and/or
mobilization and manipulation.
Supporting Evidence
There were no studies of sufficient quality identified that examined the use of massage,
joint mobilization, joint manipulation, exercise, phonophoresis, iontophoresis, ultrasound,
laser treatments, acupuncture, and/or electrical stimulation. in patients with
glenohumeral osteoarthritis. Further, no studies of sufficient quality were found that
addressed massage therapy, hydrotherapy, manual therapy and/or mobilization and
manipulation.
Rationale:
Conservative management of pain secondary to osteoarthritis frequently includes
pharmacologic treatment. Non steroidal anti-inflammatories, acetaminophen, opioids,
and over–the-counter supplements are routinely used. Despite an exhaustive literature
review, there is insufficient evidence to support or refute the use of the pharmacologic
treatments for shoulder arthritis.
Supporting Evidence
There were no studies of sufficient quality identified that examined the use of NSAID
therapy, topical therapy, acetaminophen interventions, vitamin C and B interventions,
chondroitin sulfate interventions, opium or narcotic therapy, oral corticosteroid
interventions, or any herbal therapy in patients with glenohumeral osteoarthritis.
Rationale:
There is no evidence to support or refute the use of intra-articular steroid injection for the
treatment of osteoarthritis of the shoulder, whether performed with or without
fluoroscopic, ultrasound or CT guidance.
Corticosteroid injections are used widely in clinical practice for patients with shoulder
pain of all etiologies, and occasionally they are employed in conjunction with physical
therapy as an initial treatment for patients with shoulder pain. Intra-articular injections
are used for the treatment of osteoarthritis in other joints. The current literature does not
support or refute the use of intra-articular steroid injection for the treatment of
glenohumeral osteoarthritis
Supporting Evidence
There were no studies of sufficient quality identified that examined the use of injectable
corticosteroids in the treatment of osteoarthritis of the shoulder.
Definition: A Limited recommendation means the quality of the supporting evidence that exists
is unconvincing, or that well-conducted studies show little clear advantage to one approach versus
another.
Rationale:
Currently we have one, industry supported, study 5 that met the inclusion criteria
supporting the use of intra-articular injection of sodium hyaluronate preparations in
patients with shoulder pain. Hyaluronic acid injections have been evaluated in the
treatment of shoulder osteoarthritis, demonstrating a statistically significant benefit in
pain relief, range of motion and quality of life as measured by the VAS, SST, and UCLA
outcome measures.
Supporting Evidence
Tables relevant to this recommendation are:
Table 5
Figures relevant to this recommendation are: Figure 1 through Figure 4
To address this study we included one Level IV study by Silverstein, et al.5 that assessed
patients with osteoarthritis of the glenohumeral joint treated with viscosupplementation.
Patients received three Hylan G-F 20 injections weekly for three weeks. One pain
measurement (see Figure 1), two global health assessments (see Figure 2 and Figure 3)
and one quality of life assessment (see Figure 4) are reported at the durations of 1, 3, and
6 months after the final injection. For each outcome measure, the change from baseline
is statistically significant; however, these results are based on limited evidence.
Duration
Authors Outcome Domain Outcome LoE Comparison N 1 3 6
UCLA 25 ● ● ●
Silverstein, Global Change from
et al. Assessment IV
SST- Number of "yes" Baseline
2007 25 ● ● ●
responses
SST- Percent of patients
Quality of Life able to sleep 25 ● ● ●
comfortably
100
90
80
70
VAS Pain
60
50
40
30
20
10
0
0 Month 1 Months 3 Months 6 Months
UCLA SCORE
The modified UCLA score consists of the sum of the individual scores for pain, function,
motion, and strength as well as each individual score calculated for each visit. Silverstein,
et al. 5 report a statistically significant improvement between 0 months and 1 month
(p=.001), 0 months and 3 months (p=.001), and between 0 months and 6 months
(p=.001).
25
20
UCLA Score
15
10
0
0 Month 1 Months 3 Months 6 Months
10
SST- Number of positive responses
9
8
7
6
5
4
3
2
1
0
0 Month 1 Months 3 Months 6 Months
100
SST-Percent of patients able to sleep
90
80
70
comfortably
60
50
40
30
20
10
0
0 Month 1 Months 3 Months 6 Months
Rationale:
There is a concern for performing shoulder arthroplasty in patients under the age of 50
because of potential risk of increased prosthetic loosening and decreased survivorship of
the prosthesis in this patient population. Patients with early stages of osteoarthritis may
not have symptoms severe enough to warrant or be willing to undergo shoulder
arthroplasty procedure. For this reason, arthroscopic options in the treatment of
glenohumeral osteoarthritis are of interest. The role for arthroscopic surgical intervention
in the treatment algorithm for osteoarthritis of the glenohumeral joint is inconclusive.
Despite an exhaustive review of literature, there was insufficient evidence to make
conclusions either in favor or against the efficacy of arthroscopic treatment, including
glenohumeral debridement, capsular release, chondroplasty, microfracture, removal of
loose bodies, biologic and interposition grafts, subacromial decompression, distal clavicle
resection, biceps tenotomy or tenodesis, and labral repair or advancement in the treatment
of the glenohumeral arthritis of the shoulder. This review was limited to the treatment of
glenohumeral arthrosis and does not pertain to subacromial bursitis, acromio-clavicular
arthrosis or impingment nor rotator cuff tendonopathy.
Supporting Evidence
There were no studies of sufficient quality identified examining arthroscopic
debridement, capsular release, chondroplasty, microfracture, removal of loose bodies,
biologic and interpositional grafts, subacromial decompression, distal clavical resection,
biceps tenotomy or tenodesis, or labral repair or advancement in patients with
osteoarthritis of the glenohumeral joint.
Rationale:
There is a concern for performing shoulder arthroplasty in younger patients because of
potential risk of increased prosthetic loosening and decreased survival of the prosthesis.
The role for open debridement and non-prosthetic and /or interposition arthroplasty in the
treatment algorithm for osteoarthritis of the glenohumeral joint is inconclusive. Despite
an exhaustive review of literature, there was insufficient evidence to make conclusions
either in favor or against the efficacy of open debridement and non-prosthetic and /or
interposition arthroplasty, including osteoarticular allograft, interpositional soft tissue
allograft, and autograft in the treatment of the glenohumeral arthritis of the shoulder.
Supporting Evidence
There were no studies of sufficient quality identified examining open debridement and/or
non-prosthetic or biologic interposition arthroplasty in patients with osteoarthritis of the
glenohumeral joint.
Definition: A Limited recommendation means the quality of the supporting evidence that exists
is unconvincing, or that well-conducted studies show little clear advantage to one approach versus
another.
Rationale:
The body of evidence4, 16, 17, 18, 19 , 20, 21 supports the use of total shoulder arthroplasty or
hemiarthroplasty for glenohumeral osteoarthritis. However, there is no reliable evidence
for the use of humeral resurfacing in the existing literature for the treatment of
glenohumeral joint osteoarthritis. Total shoulder arthroplasty or hemiarthroplasty provide
significant improvements in pain, global health assessment, function, and quality of life
scores 4, 16, 17, 18, 19, 20, 21. The majority of studies 4, 18, 21 supported the use of
hemiarthroplasty when performed in patients with naturally concentric glenoids or those
reamed to concentricity.
Supporting Evidence
Tables relevant to this recommendation are: Table 6 through Table 9
Figures relevant to this recommendation are: Figure 5 through Figure 69
Ability to toss
Fehringer, et al.
softball twenty V 102 ●
2002
yards overhand
Ability to toss
Fehringer, et al.
softball twenty V 102 ○
2002
yards underhand
Ability to work
Fehringer, et al.
full time in a V 102 ●
2002
regular job
Ability to wash
Fehringer, et al. back of
V 102 ●
2002 contralateral
shoulder
Change
Fehringer, et al. Ability to place from
V Baseline 102 ●
2002 coin on shelf
Ability to carry
Fehringer, et al.
twenty pounds at V 102 ●
2002
side
Norris and
Ability to use
Iannotti V 94 ●
arm
2002
Boorman, et al. Mental health-
V 91 ○
2003 SF-36
Change
Iannotti, et al. Quality of Quality of Life-
V from 95 ●
2003 Life VAS
Baseline
Boorman, et al. General health
V 91 ●
2003 perception-SF-36
20
18
16
Constant- Murley Pain
14
12
10
8
6
4
2
0
0 Years 2 Years
100
80
60
VAS Pain
40
20
0
0 Months 46 Months
-20
100
90
80
70
VAS Pain
60
50
40
30
20
10
0
0 Years 4.3 Years
50
45
40
35
ASES Pain
30
25
20
15
10
5
0
0 Months 36 Months
10
9
8
7
UCLA Pain
6
5
4
3
2
1
0
0 Months 36 Months
80
70
60
50
40
30
20
10
0
0 Years 2 Years
60
50
40
30
20
10
0
0 Months 36 Months
100
80
ASES Score
60
40
20
0
0 Months 46 Months
10
8
SST Score
0
0 Months 46 Months
UCLA
Gartsman, et al.18 reported a statistically significant improvement in UCLA score from
baseline (p<.0005).
30
25
UCLA Score
20
15
10
0
0 Months 36 Months
25
Constant-Murley Activity
20
15
10
0
0 Years 2 Years
25
20
Constant-Murley Power
15
10
0
0 Years 2 Years
40
35
Constant-Murley Mobility
30
25
20
15
10
0
0 Years 2 Years
100
90
SF-36 Physical Function
80
70
60
50
40
30
20
10
0
0 Months 30-60 Months
40
35
30
25
20
15
10
5
0
0 Months 36 Months
10
9
8
UCLA Function
7
6
5
4
3
2
1
0
0 Months 36 Months
100
90
80
VAS Function
70
60
50
40
30
20
10
0
0 Years 4.3 Years
100
90
80
VAS Function
70
60
50
40
30
20
10
0
0 Months 46 Months
100
SF-36 Physical Role Function
90
80
70
60
50
40
30
20
10
0
0 Months 30-60 Months
STRENGTH UCLA
Gartsman, et al.18 reported a statistically significant improvement in UCLA score from
baseline (p<.0005).
10
9
8
UCLA Satisfaction
7
6
5
4
3
2
1
0
0 Months 36 Months
10
9
8
UCLA Motion
7
6
5
4
3
2
1
0
0 Months 36 Months
100%
90%
80%
70%
60%
level
50%
40%
30%
20%
10%
0%
0 Months 30-60 Months
100%
90%
80%
70%
60%
level
50%
40%
30%
20%
10%
0%
0 Months 30-60 Months
100%
90%
80%
70%
60%
at side
50%
40%
30%
20%
10%
0%
0 Months 30-60 Months
100%
90%
80%
70%
60%
head
50%
40%
30%
20%
10%
0%
0 Months 30-60 Months
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
0 Months 30-60 Months
100%
90%
80%
70%
60%
overhand
50%
40%
30%
20%
10%
0%
0 Months 30-60 Months
100%
90%
80%
70%
yards underhand
60%
50%
40%
30%
20%
10%
0%
0 Months 30-60 Months
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
0 Months 30-60 Months
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
0 Months 30-60 Months
Figure 35 Percent of patients able to wash the back of the contra lateral shoulder
Percent of patients able to wash the back of
100%
90%
80%
contralateral shoulder
70%
60%
50%
40%
30%
20%
10%
0%
0 Months 30-60 Months
100%
90%
80%
70%
60%
shelf
50%
40%
30%
20%
10%
0%
0 Months 30-60 Months
100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
0 Months 30-60 Months
100
90
VAS Ability to use arm
80
70
60
50
40
30
20
10
0
0 days 46 monts
100
90
SF-36 Mental Health
80
70
60
50
40
30
20
10
0
0 Months 30-60 Months
100
90
80
VAS Quality of Life
70
60
50
40
30
20
10
0
0 Months 46 Months
100
90
80
70
60
50
40
30
20
10
0
0 Months 30-60 Months
100
90
80
70
VAS Satisfaction
60
50
40
30
20
10
0
0 Months 46 Months
SATISFACTION- UCLA
Gartsman, et al.18 reported a statistically significant improvement in UCLA score from
baseline (p<.0005).
10
9
8
UCLA Satisfaction
7
6
5
4
3
2
1
0
0 Months 36 Months
100
90
80
70
SF-36 Comfort
60
50
40
30
20
10
0
0 Months 30-60 Months
100
SF-36 Emotional Role Function
90
80
70
60
50
40
30
20
10
0
0 Months 30-60 Months
Figure 46 Energy-SF-36
100
90
80
70
SF-36 Energy
60
50
40
30
20
10
0
0 Months 30-60 Months
100
90
SF-36 Social Function
80
70
60
50
40
30
20
10
0
0 Months 30-60 Months
HEMIARTHROPLASTY EFFICACY
Table 8 Results of Hemiarthroplasty- Pre and Post operative data
Duration
Outcome 34 46 2 4.3 7.5
Authors Outcome LoE Comparison N
Domain m m yr yr yr
Iannotti, et al.
Pain VAS V Change from Baseline 33 ●
2003
Wirth, et al.
Pain VAS V Change from Baseline 49 ● ○*
2006
Orfaly, et al.
Pain VAS V Change from Baseline 28 nr
2003
Gartsman,et al.
Pain Pain UCLA V Change from Baseline 24 ●
2000
Gartsman,et al.
Pain ASES V Change from Baseline 24 ●
2000
Wirth, et al.
Pain at Rest VAS V Change from Baseline 49 ● ○*
2006
Wirth, et al.
Pain during Sleep VAS V Change from Baseline 49 ● ○*
2006
Gartsman,et al.
ASES Score V Change from Baseline 24 ●
2000
Iannotti, et al. Global Health
ASES Score V Change from Baseline 33 ●
2003 Assessment
Gartsman,et al.
UCLA Score V Change from Baseline 24 ●
2000
Gartsman,et al.
Function UCLA V Change from Baseline 24 ●
2000
Orfaly, et al.
Function VAS V Change from Baseline 28 nr
2003
Norris and Iannotti Function VAS V Change from Baseline 32 ●
Function
Wirth, et al.
Shoulder function VAS V Change from Baseline 49 ● ●
2006
Gartsman,et al.
Motion UCLA V Change from Baseline 24 ●
2000
Gartsman,et al.
Strength UCLA V Change from Baseline 24 ●
2000
Gartsman,et al. Activities of Daily Living
VAS
V Change from Baseline 24 ●
2000
Iannotti, et al.
Quality of Life Quality of Life VAS V Change from Baseline 33 ●
2003
Wirth, et al.
Quality of life VAS V Change from Baseline 49 ● ○*
2006
PAIN- VAS
Patients completed the VAS pain assessment at baseline and at 46 months post operative.
Iannotti, et al.17 reported a statistically significant improvement in VAS score from
baseline (p<.0001).
100
90
80
70
VAS Pain
60
50
40
30
20
10
0
0 Months 46 Months
100
90
80
70
VAS Pain
60
50
40
30
20
10
0
0 Years 2 Years 7.5 Years
100
90
80
70
VAS Pain
60
50
40
30
20
10
0
0 Years 4.3 Years
10
9
8
7
UCLA Pain
6
5
4
3
2
1
0
0 Months 34 Months
PAIN- ASES
Gartsman, et al.18 reported a statistically significant improvement in ASES score from
baseline (p<.0005).
50
40
ASES Pain
30
20
10
0
0 months 34 months
100
90
80
VAS Pain at Rest
70
60
50
40
30
20
10
0
0 Years 2 Years 7.5 Years
100
90
80
VAS Pain during sleep
70
60
50
40
30
20
10
0
0 Years 2 Years 7.5 Years
ASES CONTINUED
Gartsman, et al.18reported a statistically significant improvement in ASES score from
baseline (p<.0005).
80
70
60
50
ASES Score
40
30
20
10
0
0 months 34 months
100
90
80
70
ASES Score
60
50
40
30
20
10
0
0 months 46 months
Figure 57 UCLA
35
30
25
UCLA Score
20
15
10
0
0 months 34 months
FUNCTION- UCLA
Gartsman, et al.18 reported a statistically significant improvement in UCLA score from
baseline (p<.0005).
10
9
8
7
UCLA Function
6
5
4
3
2
1
0
0 Months 34 Months
100
90
80
70
VASFunction
60
50
40
30
20
10
0
0 Years 4.3 Years
100
90
80
VAS Shoulder Function
70
60
50
40
30
20
10
0
0 months 46 months
5
4.5
4
3.5
UCLA Motion
3
2.5
2
1.5
1
0.5
0
0 Months 34 Months
100
90
VAS Shoulder Function
80
70
60
50
40
30
20
10
0
0 Years 2 Years 7.5 Years
5
4.5
4
3.5
UCLA Strength
3
2.5
2
1.5
1
0.5
0
0 Months 34 Months
40
35
ASES Activities of Daily Living
30
25
20
15
10
0
0 months 34 months
100
90
80
VAS Quality of Life
70
60
50
40
30
20
10
0
0 Months 46 Months
100
90
80
VAS Quality of Life
70
60
50
40
30
20
10
0
0 Years 2 Years 7.5 Years
100
90
80
VAS Satisfaction
70
60
50
40
30
20
10
0
0 Months 46 Months
5
4.5
4
UCLA Satisfaction
3.5
3
2.5
2
1.5
1
0.5
0
0 Months 34 Months
100
90
80
VAS Work and Play
70
60
50
40
30
20
10
0
0 Years 2 Years 7.5 Years
Lo, et al.
Intraoperative fracture Hemi 10% 21 Treated during surgery
2005
Cofield, et al.
Humeral shaft fracture Hemi 3% 35 Treated during surgery
1995
Cofield, et al.
Hematoma Hemi 3% 35 Surgical evacuation
1995
Definition: A Moderate recommendation means that the benefits exceed the potential harm (or
that the potential harm clearly exceeds the benefits in the case of a negative recommendation), but
the strength of the supporting evidence is not as strong.
Implications: Practitioners should generally follow a Moderate recommendation but remain alert
to new information and be sensitive to patient preferences.
Rationale:
There were only two studies of sufficient quality to meet our inclusion criteria comparing
total shoulder arthroplasty to hemiarthroplasty.18, 25 The largest of these studies reported
that global health assessment scores and pain relief were statistically significantly better
after total shoulder arthroplasty. Function and quality of life outcome measures in both
studies showed no statistically significant differences between groups. No total shoulder
arthroplasty required revision to hemiarthroplasty. However, 14% of patients treated
with a hemiarthroplasty required revision to a total shoulder arthroplasty because of
progressive glenoid arthrosis and pain. This difference in revision rates must be
considered when contemplating shoulder arthroplasty and the possibility of a second
operative exposure.
Supporting Evidence
We included two Level II studies, Gartsman, et al. (2000) and Lo, et al. (2005) that
compare patients with glenohumeral osteoarthritis treated with either total shoulder
arthroplasty or hemiarthroplasty.
Duration
Months
Outcome
Authors Domain Outcome LoE Comparison N 24 35 46
Post Operative Score in Hemiarthroplasty group
Gartsman, et al. vs.
Pain ASES II 51 ●tsa
2000 Post Operative Score in Total Shoulder
Arthroplasty
Pain
Post Operative Score in Hemiarthroplasty group
Gartsman, et al. vs.
Pain UCLA II 51 ●tsa
2000 Post Operative Score in Total Shoulder
Arthroplasty
Post Operative Score in Hemiarthroplasty group
Gartsman, et al. vs.
ASES II 51 ?
2000 Post Operative Score in Total Shoulder
Arthroplasty
Post Operative Score in Hemiarthroplasty group
Lo, et al. vs.
ASES II 41 ?
2005 Post Operative Score in Total Shoulder
Global Health Arthroplasty
Assessment Post Operative Score in Hemiarthroplasty group
Lo, et al. vs.
Constant and Murley II 41 ○
2005 Post Operative Score in Total Shoulder
Arthroplasty
Post Operative Score in Hemiarthroplasty group
Lo, et al. vs.
UCLA II 41 ○
2005 Post Operative Score in Total Shoulder
Arthroplasty
?= not sufficiently powered to detect MCII; neither statistically or clinically significant ●= statistically significant difference ○= no statistically
significant difference
PAIN-ASES
Patients with osteoarthritis of the glenohumeral joint assessed pain using the ASES.
Gartsman, et al.18 reported a statistically significant difference in pain relief, in favor of
TSA, at thirty five months.
HHS TSA
50
45
40
ASES Pain Score
35
30
25
20
15
10
5
0
0 Months 35 Months
10 HHS TSA
9
8
7
UCLA Pain
6
5
4
3
2
1
0
0 Months 35 Months
ASES
Gartsman, et al.18compared ASES results of patients treated with total shoulder
arthroplasty (n=27) to patients treated with hemiarthroplasty (n=24) using the ASES
outcome measure. Patients completed the ASES scoring system at thirty five months
(range, 24-72 months). The authors reported no statistically significant difference in
ASES scores between the two groups. However, this study was not powered sufficiently
to detect the MCII.
Figure 72 ASES Score
N, mean
ASES 0.55 (-0.01, 1.11) 27, 77.3 (18.2) 24, 65.2 (24.9)
0 .2 .39.5 .8
Favors Hemi-Arthroplasty Favors Total Arthroplasty
ASES 0.38 (-0.23, 1.00) 20, 91.1 (14.3) 21, 83.1 (25.6)
0 .2 .39 .5 .8
Favors Hemi-Arthroplasty Favors Total Arthroplasty
Constant-Murley Score 0.20 (-0.41, 0.81) 20, 70.8 (17.2) 21, 67.1 (19.6)
0 .2 .5 .8
Favors Hemi-Arthroplasty Favors Total Arthroplasty
N, mean N,
UCLA 1.01 (0.43, 1.60) 27, 27.4 (4.9) 24, 23.2 (2.9)
0 .2 .5 .8
Favors Hemi-Arthroplasty Favors Total Arthroplasty
UCLA 0.55 (-0.07, 1.18) 20, 26.7 (3.8) 21, 24.2 (5)
0 .2 .5 .8
Favors Hemi-Arthroplasty Favors Total Arthroplasty
FUNCTION- UCLA
Patients with osteoarthritis of the glenohumeral joint assessed function with the UCLA 35
months post operative (range 24-72 months). Gartsman, et al.18compared results of the
UCLA function assessment in patients treated with total shoulder arthroplasty (n= 24) to
the results of those treated with hemiarthroplasty (n=27). Authors report no statistically
significant difference between groups (p=.097).
10 HHS TSA
9
8
7
UCLA Function
*
6
5
4
3
2
1
0
0 Months 35 Months
5 HHS TSA
4.5
4 *
3.5
UCLA Motion
3
2.5
2
1.5
1
0.5
0
0 Months 35 Months
5 HHS TSA
4.5
4 *
3.5
UCLA Strength
3
2.5
2
1.5
1
0.5
0
0 Months 35 Months
40 TSA HHS
ASES Activities of Daily Living
35 *
30
25
20
15
10
0
Pre Op 35 months
SF-36: Physical Component -0.07 (-0.68, 0.55) 20, 42.1 (13.2) 21, 42.9 (10.9)
0 .2 .5 .8
Favors Hemi-Arthroplasty Favors Total Arthroplasty
WOOS Total 0.47 (-0.16, 1.09) 20, 90.6 (13.2) 21, 81.5 (24.1)
0 .2 .5 .8
Favors Hemi-Arthroplasty Favors Total Arthroplasty
WOOS: Physical Symptoms 0.48 (-0.14, 1.10) 20, 91.9 (12.8) 21, 82.7 (23.5)
0 .2 .5 .8
Favors Hemi-Arthroplasty Favors Total Arthroplasty
WOOS: Sports/Recreation/Work 0.43 (-0.19, 1.05) 20, 86.1 (20.8) 21, 75.2 (28.9)
0 .2 .5 .8
Favors Hemi-Arthroplasty Favors Total Arthroplasty
WOOS: Lifestyle 0.35 (-0.27, 0.97) 20, 89.7 (13.8) 21, 82.5 (25.4)
0 .2 .5 .8
Favors Hemi-Arthroplasty Favors Total Arthroplasty
WOOS: Emotions 0.57 (-0.05, 1.20) 20, 97 (4.6) 21, 87.1 (23.7)
0 .2 .5 .8
Favors Hemi-Arthroplasty Favors Total Arthroplasty
SF-36: Mental Component 0.10 (-0.51, 0.71) 20, 58.4 (9.1) 21, 57.4 (10.9)
0 .2 .5 .8
Favors Hemi-Arthroplasty Favors Total Arthroplasty
5 HHS TSA
4.5
4
UCLA Satisfaction
3.5 *
3
2.5
2
1.5
1
0.5
0
0 Months 35 Months
%
Responsive Action to Responsive Action to
Author Adverse Event HHS N TSA N complications in
Event by Physician Event by Physician
TSA vs. HHS
Gartsman, et
Severe pain 0% 24 Not applicable 4% No additional surgery ○
al. 2000 27
Lo, et al.
Intraoperative Fracture 10% Fixed during surgery 0% Not applicable ●
2005 21 20
Anterosuprior instability of
Lo, et al.
the prosthesis at 6 months 5% No additional surgery 0% Not applicable ○
2005 21 20
post surgery
Treated with two
operative debridements
Lo, et al. Infection 2 weeks post two weeks after
0% Not applicable 5% ○
2005 surgery 21 20 surgery and
intravenous antibiotics
for six weeks
Superior migration of the
Lo, et al.
humeral component with 5% Revision 0% Not applicable ○
2005 21 20
rotator cuff deficiency
Revision (16-19
Lo, et al.
Progressive Glenoid Arthrosis 14% months after initial 0% Not applicable ●
2005 24 20
surgery)
○= No statistically significant difference between groups
● = Statistically significant in favor of total shoulder arthroplasty
Definition: A Limited recommendation means the quality of the supporting evidence that exists
is unconvincing, or that well-conducted studies show little clear advantage to one approach versus
another.
Rationale:
Two studies26, 27 reported increased early postoperative complication rates and increased
length of stay when shoulder arthroplasty is performed by low volume surgeons. Low
volume was defined as surgeons who perform less than two shoulder arthroplasties per
year. Complications were only defined in one study and included mortality, wound
dehiscence, early postoperative infection, pulmonary embolism, deep vein thrombosis,
and “operative mishaps”. Complications following discharge were not assessed in either
study when comparing the low volume and high volume surgeons. No patient outcome
measurements or clinical assessments were reported in either study.
Supporting Evidence
We included two Level IV 26, 27 studies that reported four outcome measures (please see
Figure 89 through Figure 93).
Hammond, et al.27 compared surgeon volume with complication rates. The authors
categorized surgeons based upon total number of procedures performed during a seven
year time frame (see Table 13) and compared surgeon volume with risk of complication.
The authors reported a statistically significant difference in the risk of complications in
surgeries performed by low volume surgeons when compared to high volume surgeons
(statistics were adjusted for adjusted for: procedure, age, gender, race, marital status, co
morbidities, diagnosis, insurance status, income, and hospital volume (see Figure 89).
Events, Events,
.409 1 2.45
Favors Lower Volume Favors Higher Volume
Events,
.398 1 2.51
Favors Smaller Volume Favors Larger Volume
Hammond, et al.27 compared surgeon volume with length of hospital stay (more than six
days versus less than six days) and categorized surgeons based upon total number of
procedures performed during a seven year time frame (see Table 15). Authors reported
that patients of low-volume surgeons stayed in the hospital 1.4 days longer than high
volume surgeons. The authors reported that high volume surgeons were three times
more likely than low-volume surgeons to have patients with a hospital stay of less than
six days (OR, 0.3 CI 0.2, 0.6) (statistics adjusted for: procedure, age, gender, race,
marital status, co morbidities, diagnosis, insurance status, income, and hospital volume) .
OR (95%
.2 1 5
Favors High Volume Favors Low Volume
Figure 92 Length of hospital stay in TSA patients compared with surgeon volume
N, N,
0 .2 .5 .8
Favors Smaller Volume Favors Larger Volume
0 .2 .5 .8
Favors Smaller Volume Favors Larger Volume
TSA Mortality
Adjusted Odds Ratio
Procedure Volume Percent of Mortality
(95% Confidence Interval)
<2 36.0% 4.4 (0.6-31.2)
≥2 to <4 32.0% 4.2 (0.6-29.6)
≥4 20.0% 1
HHS Mortality
Adjusted Odds Ratio
Procedure Volume Percent of Mortality
(95% Confidence Interval)
<2 0.50% 0.9 (0.3-2.3)
≥2 to <4 0.36% 0.7 (0.2-1.9)
≥4 0.38% 1
Definition: A Consensus recommendation means that expert opinion supports the guideline
recommendation even though there is no available empirical evidence that meets the inclusion
criteria.
Rationale:
Venous thromboembolism and pulmonary embolism are recognized potentially
catastrophic complications faced by all patients who undergo shoulder arthroplasty.
Despite the paucity of evidence to support or refute the use of embolic prophylaxis in
shoulder arthroplasty patients, the consensus opinion of our work group is to employ its
routine use. Mechanical prophylaxis for shoulder arthroplasty patients intra-operatively
and during the immediate postoperative period places the patient at minimal additional
risk or discomfort and may help prevent pulmonary embolism. Each patient should be
assessed for the risk of pulmonary embolism and the addition of chemical prophylaxis
considered if appropriate. The level of embolic risk must be weighed against the
potential bleeding risk in these patients as well. We believe these actions are consistent
with the current practice of most Orthopaedic surgeons. The AAOS has produced a
guideline for the prevention of pulmonary embolus in lower extremity surgery, which can
also serve as a reference; however, the risks for lower extremity surgery are reported to
be higher than shoulder surgery.28 As such these guidelines may not be applicable to this
patient population.
Supporting Evidence
There were no studies of sufficient quality found that address this recommendation.
Definition: A Limited recommendation means the quality of the supporting evidence that exists
is unconvincing, or that well-conducted studies show little clear advantage to one approach versus
another.
Rationale:
Studies have demonstrated that total shoulder arthroplasty provides improved outcomes
in terms of pain relief and function (see Recommendation 7). The concept of performing
a pegged or keeled glenoid has been studied extensively from a biomechanical
standpoint, but limited data has been available regarding the clinical outcome, durability,
and component stability when comparing the two types of resurfacing designs. As such,
design considerations have long been considered an important variable when applied to
the glenoid component.
One study29 has evaluated the objective outcome and implant stability when comparing
the keeled and pegged implant. The authors revealed there was no statistically significant
difference between the designs in terms of pain relief and functional improvement in
patients following total shoulder arthroplasty. The radiostereometric analysis performed
at regular intervals during a two-year follow-up demonstrated greater micromotion in the
keeled design group. Although this did not have an impact on short-term outcomes, this
may suggest long-term implications with regards to implant loosening and progressive
clinical symptoms.
Supporting Evidence
One study29 examines clinical outcomes of both pegged and keeled glenoid components.
10
9
8
7
VAS Pain
6
5
4
3
2
1
0
Pre Operative Post Operative
100
90
80
Constant-Murley Score
70
60
50
40
30
20
10
0
Pre Operative Post Operative
100
90
80
70
ASES Score
60
50
40
30
20
10
0
Pre Operative Post Operative
Three Level V outcome measures assess the efficacy of the use of keeled glenoids.
10
9
8
7
VAS Pain
6
5
4
3
2
1
0
Pre Operative Post Operative
Figure 98 Constant-Murley
100
90
80
Constant-Murley Score
70
60
50
40
30
20
10
0
Pre Operative Post Operative
Figure 99 ASES
100
90
80
70
ASES Score
60
50
40
30
20
10
0
Pre Operative Post Operative
SCREW FIXATION
There were no studies of sufficient quality identified which assessed screw fixation in
glenoid components.
BONE IN GROWTH
There were no studies of sufficient quality identified which assessed bone in growth
glenoid components.
TRABECULAR METAL
There were no studies of sufficient quality identified which assessed cemented trabecular
metal glenoid components.
BIOLOGIC
There were no studies of sufficient quality identified which assessed biologic glenoid
components.
Definition: A Consensus recommendation means that expert opinion supports the guideline
recommendation even though there is no available empirical evidence that meets the inclusion
criteria.
Rationale:
In the setting of an irreparable rotator cuff tear, glenoid component loosening is a
potential complication of total shoulder arthroplasty due to the increased eccentric rim
loading of the glenoid component that can occur. This has been termed the rocking horse
phenomenon. Loosening and failure of the glenoid component can lead to pain and
decreased function and may ultimately necessitate revision surgery. Currently, no
reliable studies exists comparing clinical or radiographic results of total shoulder
arthroplasty in patients with and without irreparable rotator cuff tears. Despite this, the
current “best medical practice” is to perform total shoulder arthroplasty in patients with
glenohumeral osteoarthritis who have intact or reparable rotator cuffs.
Supporting Evidence
No studies of sufficient quality have been identified which examine TSA in patients with
glenohumeral osteoarthritis with and without an intact rotator cuff.
Rationale:
Currently, some surgeons routinely sacrifice the biceps tendon at the time of arthroplasty
and others preserve it, however these practice habits are either anecdotal or based on
“experience”. Because of the paucity of the current body of literature and the variety of
techniques used to address the biceps tendon at the time of shoulder arthroplasty, we are
unable to support either routine biceps tenotomy or tenodesis.
Supporting Evidence
There were no studies of sufficient quality identified examining tenotomy or tenodesis
when performing shoulder arthroplasty in patients with glenohumeral joint osteoarthritis.
Rationale:
Non-healing or rupture of the subscapularis tendon repair following total shoulder
arthroplasty is a recognized complication of the transtendinous approach. Deficiency of
the subscapularis tendon can lead to poor results after total shoulder arthroplasty.
Patients may complain of pain and difficulty with simple tasks like reaching the
contralateral axilla or getting the arm behind the back to tuck in a shirt or reach into a
back pocket. In addition, instability of the prosthesis, ranging from subluxations to overt
dislocation, may occur. This has prompted some investigators to study osteotomy of the
lesser tuberosity during surgical approach in shoulder arthroplasty. Lesser tuberosity
osteotomy repair results in bone-to-bone healing, which may be more reliable than
tendon-to-tendon or tendon-to-bone healing. While several studies have been published
examining results of lesser tuberosity osteotomy following total shoulder arthroplasty in
patients with glenohumeral osteoarthritis, they did not meet our inclusion criteria. Thus,
the current available literature is insufficient to recommend for or against a lesser
tuberosity osteotomy over a trans tendonous approach.
Supporting Evidence
There were no studies of sufficient quality identified examining subscapularis trans
tendonous approach versus lesser tuberosity osteotomy in patients with glenohumeral
joint osteoarthritis.
Rationale:
Following Neer’s original humeral design in the 1950’s with monoblock stems in three
sizes, over 70 different shoulder arthroplasty systems have been developed. Modern
prosthetic design has evolved to include expanded sizes and increased modularity.
Prostheses have become more anatomic, with features like variable neck-shaft angles and
eccentric heads to allow the surgeon to more closely replicate the patient’s normal
anatomy. Surgeons can choose between prostheses designed for cemented or
uncemented use. Purported advantages of one prosthetic design over another have been
claimed. Despite this, no clinical studies of sufficient quality comparing different designs
and fixation options were identified. Thus, the current available literature is insufficient
to recommend for or against a specific type of humeral prosthetic design or method of
fixation when performing shoulder arthroplasty in patients with glenohumeral
osteoarthritis.
Definition: An Inconclusive recommendation means that there is a lack of compelling evidence resulting
in an unclear balance between benefits and potential harm.
Implications: Practitioners should feel little constraint in deciding whether to follow a recommendation
labeled as Inconclusive and should exercise judgment and be alert to future publications that clarify
existing evidence for determining balance of benefits versus potential harm. Patient preference should
have a substantial influencing role.
Rationale:
Formal physical therapy has been a consistent recommendation following shoulder arthroplasty.
Despite this common practice there are no high quality studies that address whether physical
therapy improves outcomes following shoulder arthroplasty.
Supporting Evidence
There were no studies of sufficient quality identified examining physical therapy following
shoulder arthroplasty in patients with glenohumeral osteoarthritis. There were seven studies that
addressed Recommendations 7 and 8. Four of the seven studies reported that the patients
underwent an exercise protocol following surgery, but did not separately examine the effect, if
any of physical therapy. The comparison of arthroscopic surgery alone versus the results of
surgery plus physical therapy has not been made; therefore, the benefit of physical therapy has
not been determined.
In summary, we have no strong data to support any treatment for glenohumeral joint
osteoarthritis and moderate and limited strength data to support surgery. Limited data suggests
viscosupplementation may be a beneficial non operative treatment but we derive this data from
one industry supported study. In addition, no high quality data currently exists to support pre or
post operative physical therapy. Despite this, physical therapy is common practice. Clearly, we
need high quality studies that address the benefits of preoperative physical therapy and whether
physical therapy improves outcomes following shoulder arthroplasty.
Controversy will continue to exist regarding the optimal treatment of glenohumeral joint
osteoarthritis until the quality of research improves. Treatment options for orthopaedic patients
should be better grounded in quality data garnered from properly designed clinical trials
designed with sufficient power to determine optimal treatments in every phase of disease
progression.
1. Trials designed to evaluate the role and duration of non operative treatments in the initial
management of patients diagnosed with glenohumeral joint osteoarthritis.
2. Trials designed to determine the optimal use and duration of pharmacotherapy, injected
corticosteroids and viscosupplementation in the initial treatment of patients with
glenohumeral joint osteoarthritis.
3. Trials designed to evaluate the role for arthroscopic surgical intervention in the treatment
algorithm for osteoarthritis of the glenohumeral joint.
4. Trials designed to evaluate the role for open debridement and non-prosthetic and /or
interposition arthroplasty in younger patients (<50 years old).
5. Trials designed to collect prospective data on resurfacing arthroplasty and to evaluate the
indications for resurfacing would also be helpful.
6. Trials designed to evaluate the need for embolic prophylaxis, both mechanical and
chemical, for all patients undergoing total shoulder arthroplasty. Ideally, this trial will be
designed to clarify the level of embolic risk for patients while also weighing the potential
bleeding risk in these patients.
8. Finally, formal physical therapy is a standard of treatment care following total shoulder
arthroplasty. Trials to support the efficacy of post-operative physical therapy, by
improved patient outcomes following total shoulder arthroplasty, must be done to
validate this routine practice.
The future of the healthcare environment is being driven by patients who are better informed, by
third party payors who are demanding proven treatment efficacy and cost efficiency and by pay
for performance initiatives. The treatment of patients with glenohumeral joint osteoarthritis will
require better high quality research to sustain treatment options in the future.
The Council is comprised of the chairs of the AAOS Biological Implants, Biomedical
Engineering, Evidence Based Practice, Guidelines and Technology Oversight,
Occupational Health and Workers’ Compensation, Patient Safety, Research
Development, and US Bone and Joint Decade committees. Also on the Council are the
AAOS second vice-president, representatives of the Diversity Advisory Board, the
Women's Health Issues Advisory Board, the Board of Specialty Societies (BOS), the
Board of Councilors (BOC), the Communications Cabinet, the Orthopaedic Research
Society (ORS), the Orthopedic Research and Education Foundation (OREF), and three
members at large.
Board of Directors
The 17 member AAOS Board of Directors manages the affairs of the AAOS, sets policy,
and determines and continually reassesses the Strategic Plan.
The National Guidelines Clearinghouse was searched using the following strategy:
The TRIP Database – Guidelines and Systematic Reviews was searched using the
following strategy:
15 articles included
The data elements below were extracted into electronic forms in Microsoft® Excel
Microsoft® Access from published studies. The extracted information includes:
GUIDELINE RECOMMENDATION___________________________________
PRELIMINARY STRENGTH OF
RECOMMENDATION:________________________________________
Please list the benefits (as demonstrated by the systematic review) of the intervention
Please list the harms (as demonstrated by the systematic review) of the intervention
Please list the benefits for which the systematic review is not definitive
Please list the harms for which the systematic review is not definitive
Please circle the above outcomes that are critical for determining whether the intervention
is beneficial and whether it is harmful
Are data about critical outcomes lacking to such a degree that you would lower the
preliminary strength of the recommendation?
Is the applicability of the evidence for any of the critical outcomes so low that
substantially worse results are likely to be obtained in actual clinical practice?
Are there trade-offs between benefits and harms that alter the strength of
recommendation obtained in STEP 3?
Does the strength of the existing evidence alter the strength of recommendation obtained
in STEP 4?
NOTE: Because we are not performing a formal cost analyses, you should only consider
costs if their impact is substantial.
Number of Permissible
Workgroup Size
Dissenters
Not allowed. Statistical
≤3 significance cannot be
obtained
4-5 0
6-8 1
9 1 or 2
OPINION-BASED RECOMMENDATIONS
Every guideline contains preliminary recommendations that are backed by little or no
data. Under such circumstances, workgroups often want to issue opinion-based
recommendations. Although doing so is sometimes acceptable in an evidence-based
guideline (after all, expert opinion is a form of evidence), it is also important to avoid
• Not contain the AAOS guideline language “We Recommend”, “We suggest”
or “treatment x is an option”.
Work group members will write rationales for written recommendations on the
evening of the first day of the final workgroup meeting. When the work group re-
convenes on the second day of its meeting, it will vote on the rationales. The
typical voting rules will apply (see checklist). If the work group cannot adopt a
rationale after three votes, the rationale and the opinion-based recommendation
will be withdrawn, and a “recommendation” stating that the group can neither
recommend for or against the recommendation in question will appear in the
guideline.
2. Does the recommendation address the potential harms that will be incurred if it is
implemented and, if these harms are serious, does the recommendation justify;
a. (a) why the potential benefits outweigh the potential harms and/or
b. (b) why an alternative course of treatment (or diagnostic workup) that
involves less serious or fewer harms is not being recommended?
3. Does the rationale explain why the workgroup chose to make a recommendation
in the face of minimal evidence while, in other instances, it chose to make no
recommendation in the face of a similar amount of evidence?
4. Does the rationale explain that the recommendation is consistent with current
practice?
5. If relevant, does the rationale justify why a more costly device, drug, or procedure
is being recommended over a less costly one?
The work group will vote on each of the five questions listed above (four questions if
question #5 is not relevant) using the nominal group technique. Failure to achieve
consensus that every one of the above items ranks as a 7-9 means that the
recommendation will be withdrawn and replaced by a recommendation stating that the
work group cannot recommend either for or against the service addressed in the original
recommendation.
Reviewer Information:
Name of Reviewer_________________________________________
Address_________________________________________________
City___________________ State_________________ Zip Code___________
Phone _____________________Fax ________________________
E-mail_______________________
Reviewer Instructions
Please read and review this Draft Clinical Practice Guideline and its associated
Technical Report with particular focus on your area of expertise. Your responses
are confidential and will be used only to assess the validity, clarity, and accuracy
of the interpretation of the evidence. If applicable, please specify the draft page
and line numbers in your comments. Please feel free to also comment on the
overall structure and content of the guideline and Technical Report.
If you need more space than is provided, please attach additional pages.
Please complete and return this form electronically to weis@aaos.org or fax the
form back to Jan Weis at (847) 823-9769.
Thank you in advance for your time in completing this form and giving us your
feedback. We value your input and greatly appreciate your efforts. Please send
the completed form and comments by Month, Day, Year
OVERALL ASSESSMENT
Would you recommend these guidelines for use in practice? (check one)
Unsure _______
COMMENTS:
Please provide the reason(s) for your recommendation.
Peer review of the draft guideline is completed by an outside Peer Review Panel. Outside
peer reviewers are solicited for each AAOS guideline and consist of experts in the
guideline’s topic area. These experts represent professional societies other than AAOS
and are nominated by the guideline work group prior to beginning work on the guideline.
For this guideline, twelve outside peer review organizations were invited to review the
draft guideline and all supporting documentation. Seven societies participated in the
review of this guideline draft and all explicitly consented to be listed as a peer review
organization in this appendix. The organizations that reviewed the document are listed
below:
Individuals who participated in the peer review of this document and gave their consent
to be listed as reviewers of this document are:
Again, participation in the AAOS guideline peer review process does not
constitute an endorsement of the guideline by the participating
organizations or the individuals listed above.
For this guideline, members could submit public comments from September 17 to
October 17, 2009. The physician members of the AAOS Board of Directors (BOD),
Council on Research, Quality Assessment, and Technology (CORQAT) and members of
the Board of Specialty Societies (BOS) and Board of Councilors (BOC) were given the
opportunity to comment on this guideline.
Twelve members of the BOS requested that the guideline materials be forwarded to them
for review. No BOS member returned comments. Six members of the BOC requested that
the guideline materials be forwarded to them for review. No BOC member returned
comments.
For example, in the figure below the odds of a patient experiencing Outcome 1 are 5.9
times greater for patients who received Treatment B than for patients who received
Treatment A.. This result is statistically significant because the 95% Confidence Interval
does not cross the “no effect” line. In general, the plots are arranged such that results to
the left of the “no effect” line favor Treatment A while results to the right favor
Treatment B. In the example below, the odds ratio for Outcome 1 favors Treatment B,
the odds ratio for Outcome 3 favors Treatment A, and the odds ratio for Outcome 2 does
not favor either treatment because the 95% CI crosses the “no effect” line (i.e. the
difference is not statistically significant).
Sample Plot
1
Group A A
Treatment Group B B
Treatment
Michael Warren Keith, MD: (n). Submitted on: 10/10/2007 at 08:42 AM and last
confirmed as accurate on 04/09/2008.
William Charles Watters III, MD: 1 (North American Spine Society; Work Loss Data
Institute); 2 (The Spine Journal); 5A (Stryker; Intrinsic Therapeutics; MeKessen Health
Care Solutions). Submitted on: 10/09/2007 at 08:09 PM and last confirmed as accurate on
04/23/2008.
J Michael Wiater, MD (Beverly Hills, MI): 1 (American Shoulder and Elbow Surgeons;
Michigan Orthopaedic Society); 2 (Journal of Bone and Joint Surgery - American;
Journal of Shoulder and Elbow Surgery; Journal of the American Academy of Orthopedic
Surgeons); 5A (Zimmer; American Academy of Orthopaedic Surgeons; Corather's Health
Consulting, LLC); 7 (American Shoulder and Elbow Surgeons; William Beaumont
Hospital Research Institute). Submitted on: 10/16/2008.
Disclosure Items: (n) = Respondent answered 'No' to all items indicating no conflicts.
1=Board member/owner/officer/committee appointments; 2= Medical/Orthopaedic
Publications; 3= Royalties; 4= Speakers bureau/paid presentations;5A= Paid consultant;
5B= Unpaid consultant; 6= Research or institutional support from a publisher; 7=
Research or institutional support from a company or supplier; 8= Stock or Stock Options;
9= Other financial/material support from a publisher; 10= Other financial/material
support from a company or supplier.
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