Title: Comparative%20Effectiveness%20of%20Nonoperative%20and%20Operative%20Treatments%20for%20Rotator%20Cuff%20Tears
1Comparative Effectiveness of Nonoperative and
Operative Treatments for Rotator Cuff Tears
- Prepared for
- Agency for Healthcare Research and Quality (AHRQ)
- www.ahrq.gov
2Overview (1)
- Background Numerous approaches exist for
managing rotator cuff (RC) tears. - Purpose To compare the benefits and harms of
nonoperative and operative interventions on
clinically important outcomes in adults with
rotator cuff tears.
Seida JC, et al. Ann Intern Med 2010153246-55
Seida J, et al. AHRQ Comparative Effectiveness
Review No. 22. Available at http//effectivehealt
hcare.ahrq.gov/index.cfm/search-for-guides-reviews
-and-reports/?pageactiondisplayproductproductID
467.
3Overview (2)
- Data Sources Twelve electronic databases (1990
to September 2009), grey literature, trial
registries, and reference lists were searched. - Study Selection Controlled and uncontrolled
studies in various languages were considered. - Data Extraction Two reviewers assessed risk for
bias, and one reviewer rated the evidence by
using a modified GRADE approach.
Seida JC, et al. Ann Intern Med 2010153246-55
Seida J, et al. AHRQ Comparative Effectiveness
Review No. 22. Available at http//effectivehealt
hcare.ahrq.gov/index.cfm/search-for-guides-reviews
-and-reports/?pageactiondisplayproductproductID
467.
4Overview (3)
- Data synthesis
- 137 studies met eligibility criteria.
- All trials had high risk for bias.
- Cohort and uncontrolled studies were of moderate
quality. - Limitations
- Low-quality, limited evidence precluded
conclusions for most comparisons. - Language restrictions may have excluded some
relevant studies. - Selective outcome reporting may have introduced
bias.
Seida JC, et al. Ann Intern Med 2010153246-55
Seida J, et al. AHRQ Comparative Effectiveness
Review No. 22. Available at http//effectivehealt
hcare.ahrq.gov/index.cfm/search-for-guides-reviews
-and-reports/?pageactiondisplayproductproductID
467.
5Overview Conclusions
- Evidence is too limited to provide support for
earlier surgical intervention when compared to
the current practice of nonoperative
interventions followed by surgery if needed. - Significant improvements were seen after both
operative and nonoperative interventions. - There is limited evidence for benefits and harms
to guide choice among various operative
approaches, and insufficient evidence to choose
among nonoperative approaches. - Future studies are required.
Seida JC, et al. Ann Intern Med 2010153246-55
Seida J, et al. AHRQ Comparative Effectiveness
Review No. 22. Available at http//effectivehealt
hcare.ahrq.gov/index.cfm/search-for-guides-reviews
-and-reports/?pageactiondisplayproductproductID
467.
6Outline of the Study
- Introduction
- The comparative effectiveness review (CER)
process - Comparative effectiveness for patient-related
outcomes from - Early vs. late operative intervention
- Nonoperative vs. operative interventions
- Nonoperative interventions
- Operative interventions
- Postoperative rehabilitation
- Comparative harms
- Prognostic factors
- Future research needs
AHRQ. Methods Reference Guide for Effectiveness
and Comparative Effectiveness Reviews, Version
1.0. Available at http//effectivehealthcare.ahrq
.gov/repFiles/2007_10DraftMethodsGuide.pdf Seida
J, et al. AHRQ Comparative Effectiveness Review
No. 22. Available at http//effectivehealthcare.
ahrq.gov/index.cfm/search-for-guides-reviews-and-r
eports/?pageactiondisplayproductproductID467.
7Incidence of Rotator Cuff Tears
- Rotator cuff (RC) tears can occur because of
traumatic injury or degeneration. - Incidence of RC tears is related to increasing
age. - Fifty-four percent of patients gt60 years of age
have a partial or complete RC tear when compared
with 4 percent of adults lt40 years of age. - RC tears may be asymptomatic or cause significant
pain, weakness, and limitation of motion.
Seida J, et al. AHRQ Comparative Effectiveness
Review No. 22. Available at http//effectivehealt
hcare.ahrq.gov/index.cfm/search-for-guides-reviews
-and-reports/?pageactiondisplayproductproductID
467.
8Managing Rotator Cuff Tears
- Both nonoperative and operative treatments are
used to relieve pain and restore shoulder
movement and function. - Patients usually first undergo 6 to 12 weeks of
nonoperative treatment, which may consist of any
combination of - Pain management (medications and injections)
- Rest from activity
- Passive and active exercise
- Treatments with heat, cold, or ultrasound
Seida J, et al. AHRQ Comparative Effectiveness
Review No. 22. Available at http//effectivehealt
hcare.ahrq.gov/index.cfm/search-for-guides-reviews
-and-reports/?pageactiondisplayproductproductID
467.
9Managing Rotator Cuff Tears (2)
- The rotator cuff may be surgically repaired by
using an open, mini-open, or all-arthroscopic
approach when nonoperative therapy fails or for
certain patients with traumatic tears. - Following operative interventions, various
postoperative rehabilitation programs are used to
restore range of motion, muscle strength, and
function. - Patients and clinicians face several decisional
dilemmas, including whether to opt for early
surgical intervention or if and when to forgo
nonoperative treatment for operative
intervention.
Seida J, et al. AHRQ Comparative Effectiveness
Review No. 22. Available at http//effectivehealt
hcare.ahrq.gov/index.cfm/search-for-guides-reviews
-and-reports/?pageactiondisplayproductproductID
467.
10The CER Development Process (1)
- The publicly nominated topic was reviewed and
selected based on need, importance, and
feasibility. - Experts and stakeholders guided development of
the clinical questions that were made available
for public comment. - A specialized Technical Expert Panel assisted the
research process and development of the draft
report.
AHRQ. Methods Reference Guide for Effectiveness
and Comparative Effectiveness Reviews, Version
1.0. Available at http//effectivehealthcare.ahrq
.gov/repFiles/2007_10DraftMethodsGuide.pdf Seida
J, et al. AHRQ Comparative Effectiveness Review
No. 22. Available at http//effectivehealthcare.a
hrq.gov/index.cfm/search-for-guides-reviews-and-re
ports/?pageactiondisplayproductproductID467.
11The CER Development Process (2)
- Methods for literature review, data collection,
and meta-analysis followed version 1.0 of the
Methods Reference Guide for Effectiveness and
Comparative Effectiveness Reviews. - The draft CER was subject to public comment and
peer review. - The complete final report is available online.
AHRQ. Methods Reference Guide for Effectiveness
and Comparative Effectiveness Reviews, Version
1.0. Available at http//effectivehealthcare.ahrq
.gov/repFiles/2007_10DraftMethodsGuide.pdf Seida
JC, et al. Ann Intern Med 2010153246-55 Seida
J, et al. AHRQ Comparative Effectiveness Review
No. 22. Available at http//effectivehealthcare.a
hrq.gov/index.cfm/search-for-guides-reviews-and-re
ports/?pageactiondisplayproductproductID467.
12Clinical Questions Addressed by the CER
- Comparative effectiveness of outcomes from
- Early vs. late operative intervention
- Nonoperative vs. operative interventions
- Nonoperative interventions
- Operative interventions
- Postoperative rehabilitation
- Comparative harms from operative and nonoperative
interventions - Prognostic factors
Seida J, et al. AHRQ Comparative Effectiveness
Review No. 22. Available at http//effectivehealt
hcare.ahrq.gov/index.cfm/search-for-guides-reviews
-and-reports/?pageactiondisplayproductproductID
467.
13Clinical Outcomes of Interest
- Health-related quality of life
- Shoulder function
- Time to return to work/activities
- Cuff integrity
- Pain
- Range of motion
- Strength of the shoulder
Seida J, et al. AHRQ Comparative Effectiveness
Review No. 22. Available at http//effectivehealt
hcare.ahrq.gov/index.cfm/search-for-guides-reviews
-and-reports/?pageactiondisplayproductproductID
467.
14Four Domains Used To AssessRelevant Studies
- Risk of bias
- Consistency
- Directness
- Precision
Atkins D, et al. BMJ 20043281490 Seida J, et
al. AHRQ Comparative Effectiveness Review No. 22.
Available at http//effectivehealthcare.ahrq.gov/
index.cfm/search-for-guides-reviews-and-reports/?p
ageactiondisplayproductproductID467.
15Rating the Strength of Evidence From the CER
- The strength of evidence was classified into four
broad categories
High Further research is very unlikely to change the confidence in the estimate of effect.
Moderate Further research may change the confidence in the estimate of effect and may change the estimate.
Low Further research is likely to change the confidence in the estimate of effect and is likely to change the estimate.
Insufficient Evidence either is unavailable or does not permit estimation of an effect.
Atkins D, et al. BMJ 20043281490 Seida J, et
al. AHRQ Comparative Effectiveness Review No. 22.
Available at http//effectivehealthcare.ahrq.gov/
index.cfm/search-for-guides-reviews-and-reports/?p
ageactiondisplayproductproductID467.
16Early vs. Late Operative Intervention for Rotator
Cuff Tears
17Early vs. Late Surgical Interventionfor Rotator
Cuff Tears
- Only one study compared immediate surgical repair
with late surgical repair after failed
nonoperative treatment. - Randomized.
- Moderate sample size (n103).
- Significance not reported.
- Trend for greater improvement with immediate
surgery. - Evidence is too limited to draw conclusions about
the comparative effectiveness of early surgical
repair when compared to late surgical repair
following nonoperative interventions. - Low level of evidence.
Moosmayer S, et al. J Bone Joint Surg Br
20109283-91 Seida J, et al. AHRQ Comparative
Effectiveness Review No. 22. Available
at http//effectivehealthcare.ahrq.gov/index.cfm/
search-for-guides-reviews-and-reports/?pageaction
displayproductproductID467.
18Comparative Effectiveness of Nonoperative vs.
Operative Interventions for Rotator Cuff Tears
- Five comparative studies (2 randomized controlled
trials and 3 cohort studies)
19Comparisons Studied for Nonoperative vs.
Operative Interventions
- Shock-wave therapy vs. mini-open rotator cuff
repair (RCR). - Steroid injection, physical therapy, and activity
modification vs. open RCR. - Physical therapy (manual therapy and
strengthening and stability exercises) vs. open
or mini-open RCR. - Physical therapy, oral medication, and steroid
injection vs. open RCR vs. arthroscopic
debridement. - Steroid injection, stretching, and strengthening
vs. open RCR.
Seida J, et al. AHRQ Comparative Effectiveness
Review No. 22. Available at http//effectivehealt
hcare.ahrq.gov/index.cfm/search-for-guides-reviews
-and-reports/?pageactiondisplayproductproductID
467.
20Results for Comparative Effectiveness of
Nonoperative vs. Operative Interventions
- Significant improvements were seen in all study
groups, regardless of the intervention. - Although there was a trend for better outcomes
with surgery, results were too limited to permit
definitive conclusions. - Low level of evidence.
Seida J, et al. AHRQ Comparative Effectiveness
Review No. 22. Available at http//effectivehealt
hcare.ahrq.gov/index.cfm/search-for-guides-reviews
-and-reports/?pageactiondisplayproductproductID
467.
21Comparative Effectiveness of Nonoperative
Interventions for Rotator Cuff Tears
- Three comparative studies (1 randomized
controlled trial, 2 retrospective cohort
studies).
22Comparative Effectiveness of Nonoperative
Interventions for Rotator Cuff Tears Overview
- Nonoperative intervention comparisons studied
- Sodium hyaluronate vs. dexamethasone
- Rehabilitation vs. no rehabilitation
- Physical therapy and oral medications with or
without steroid injections - Because of the variety of interventions and the
low quality of studies, no conclusions could be
drawn about the most effective nonoperative
patient-management strategy.
Seida J, et al. AHRQ Comparative Effectiveness
Review No. 22. Available at http//effectivehealt
hcare.ahrq.gov/index.cfm/search-for-guides-reviews
-and-reports/?pageactiondisplayproductproductID
467.
23Comparative Effectiveness of Operative Repair for
Rotator Cuff Tears
- Thirty-two controlled studies (5 randomized
controlled trials, 4 controlled clinical trials,
6 prospective cohort studies, 17 retrospective
cohort studies). - Thirteen operative comparisons.
24Comparative Effectiveness ofOperative Repair for
Rotator Cuff Tears
- Functional outcomes with a few exceptions were
similar for - Open vs. mini-open repair
- Mini-open vs. arthroscopic repair
- Open or mini-open vs. arthroscopic repair
- Arthroscopic repair with or without acromioplasty
- Moderate level of evidence
Seida J, et al. AHRQ Comparative Effectiveness
Review No. 22. Available at http//effectivehealt
hcare.ahrq.gov/index.cfm/search-for-guides-reviews
-and-reports/?pageactiondisplayproductproductID
467.
25Comparative Effectiveness of Operative Repair for
Rotator Cuff Tears (2)
- Outcomes differed in these comparisons
- Mini-open vs. open repair
- Patients may return to work or sports
approximately 1 month earlier if they have a
mini-open repair (p lt 0.00001). - Open repair vs. open or arthroscopic debridement
- Open repair results in greater improvement in
functional outcomes than arthroscopic debridement
(p 0.03). - Moderate level of evidence
Seida J, et al. AHRQ Comparative Effectiveness
Review No. 22. Available at http//effectivehealt
hcare.ahrq.gov/index.cfm/search-for-guides-reviews
-and-reports/?pageactiondisplayproductproductID
467.
26Comparative Effectiveness of Operative Techniques
for Rotator Cuff Tears
- Fifteen comparative studies (6 randomized
controlled trials, 1 controlled clinical trial, 8
cohort studies) - Modest methodological quality
27Comparative Effectiveness of Operative Techniques
for Rotator Cuff Tears
- Comparative differences for postoperative
function and cuff integrity are not clinically
significant for single-row vs. double-row suture
anchor fixation. - No difference in cuff integrity between mattress
locking and simple stitch was documented. - Moderate level of evidence.
Seida J, et al. AHRQ Comparative Effectiveness
Review No. 22. Available at http//effectivehealt
hcare.ahrq.gov/index.cfm/search-for-guides-reviews
-and-reports/?pageactiondisplayproductproductID
467.
28Comparative Effectiveness of Postoperative
Rehabilitation forRotator Cuff Tears
- Eleven studies (10 comparative, 1 uncontrolled).
- Most frequently studied comparison was continuous
passive motion with physical therapy vs. physical
therapy alone (3 studies).
29Postoperative Rehabilitation Options for Rotator
Cuff Tears
- Physical therapy with or without continuous
passive motion - Land-based therapy with or without aquatic
therapy - Inpatient vs. day-patient rehabilitation
- Home exercise program with or without
individualized physical therapy programs - Early progressive activation and then resistive
exercises vs. early immobilization followed by
delayed progressive resistive exercise - Standardized vs. nonstandardized physical therapy
programs - Videotape vs. physical therapy home-exercise
instruction - No studies to compare rehabilitation to no
rehabilitation, but postoperative rehabilitation
has become the standard of care.
Seida J, et al. AHRQ Comparative Effectiveness
Review No. 22. Available at http//effectivehealt
hcare.ahrq.gov/index.cfm/search-for-guides-reviews
-and-reports/?pageactiondisplayproductproductID
467.
30Comparative Effectiveness of Postoperative
Rehabilitation for Rotator Cuff Tears
- No clinically important or statistically
significant difference in function was found, but
there was some evidence for earlier return to
work with continuous passive motion vs. physical
therapy done in postoperative patients. - Overall, there was not enough quality evidence to
determine the optimal postoperative
rehabilitation protocol.
Seida J, et al. AHRQ Comparative Effectiveness
Review No. 22. Available at http//effectivehealt
hcare.ahrq.gov/index.cfm/search-for-guides-reviews
-and-reports/?pageactiondisplayproductproductID
467.
31Additional Issues
- Augmentation Three small comparative studies
assessed augmentation, such as grafts or patches,
in the rotator cuff tear repair. Evidence was too
limited to permit conclusions. - Prognostic Factors Older age, increasing tear
size, and extent of preoperative symptoms were
associated with recurrent tears in several
studies, but evidence was too limited to permit
conclusions regarding the relationship of patient
or disease characteristics to prognosis.
Seida J, et al. AHRQ Comparative Effectiveness
Review No. 22. Available at http//effectivehealt
hcare.ahrq.gov/index.cfm/search-for-guides-reviews
-and-reports/?pageactiondisplayproductproductID
467.
32Complication Rates forRotator Cuff Tear
Interventions
- Overall, complication rates of nonoperative,
operative, and postoperative rehabilitation
interventions were low. - Postoperative complication rates (number of
patients with complications during study period) - Retears (recurrent tears) 10
- Infection 5
- Stiffness 8
- Reflex sympathetic dystrophy 2
- Neurological injury 6
Seida J, et al. AHRQ Comparative Effectiveness
Review No. 22. Available at http//effectivehealt
hcare.ahrq.gov/index.cfm/search-for-guides-reviews
-and-reports/?pageactiondisplayproductproductID
467.
33Summary of Conclusions
- Timing of Operative Intervention Evidence was
too limited to permit conclusions about the
comparative effectiveness of early surgical
repair when compared to late surgical repair
following nonoperative interventions. - Operative vs. Nonoperative Interventions
Although there was a trend for better outcomes
with surgery, results were too limited to permit
conclusions. - Nonoperative Interventions The variety of
interventions and the low quality of studies
precludes any conclusions about the most
effective nonoperative patient-management
strategy.
Seida J, et al. AHRQ Comparative Effectiveness
Review No. 22. Available at http//effectivehealt
hcare.ahrq.gov/index.cfm/search-for-guides-reviews
-and-reports/?pageactiondisplayproductproductID
467.
34Summary of Conclusions (2)
- Functional outcomes were similar for open vs.
mini-open repair mini-open vs. arthroscopic
repair open or mini-open vs. arthroscopic
repair and arthroscopic repair with or without
acromioplasty. However, exceptions were - Mini-open vs. open repair Patients may return to
work or sports approximately 1 month earlier if
they have a mini-open repair (p lt 0.00001). - Open repair vs. open or arthroscopic debridement
Open repair results in greater improvement in
functional outcomes than does open or
arthroscopic debridement (p 0.03). - Moderate level of evidence.
Seida J, et al. AHRQ Comparative Effectiveness
Review No. 22. Available at http//effectivehealt
hcare.ahrq.gov/index.cfm/search-for-guides-reviews
-and-reports/?pageactiondisplayproductproductID
467.
35Summary of Conclusions (3)
- Postoperative Rehabilitation
- Overall, patients improved over the course of
postoperative followup. However, there was not
enough quality evidence to determine the optimal
postoperative rehabilitation protocol. - Adverse Events
- In general, complication rates were low. The most
commonly reported postoperative complications
were infection and retears.
Seida J, et al. AHRQ Comparative Effectiveness
Review No. 22. Available at http//effectivehealt
hcare.ahrq.gov/index.cfm/search-for-guides-reviews
-and-reports/?pageactiondisplayproductproductID
467.
36What To Discuss With Your Patients
- Whether or not the symptoms of their rotator cuff
(RC) tear can be addressed by nonoperative or
operative interventions or both, and their values
and preferences regarding these options. - The patients role in adhering to a therapeutic
plan whether it is nonoperative or operative, as
well as in postoperative rehabilitation. - The types of surgery available if surgery is
needed. - How postoperative rehabilitation will affect
their overall clinical outcomes. - How long it may take before they will be able to
return to their normal daily activities,
depending on the required intervention. - Any other medical conditions or concerns they may
have that will influence the decision to address
the RC tear with nonoperative or operative
interventions or both.
37Gaps in Present Knowledge
- Additional comparative effectiveness research of
open, mini-open, and arthroscopic approaches is a
priority, as arthroscopic procedures are more
costly and technically more difficult. - Studies are needed on the effectiveness of early
vs. delayed surgery and nonoperative vs.
operative interventions. - Also needed are appropriate comparisons of
nonoperative treatments, the use of augmentation,
analyses of the long-term effectiveness of
treatments (minimum of 12 months), and the
influence of patient prognostic factors.
Seida J, et al. AHRQ Comparative Effectiveness
Review No. 22. Available at http//effectivehealt
hcare.ahrq.gov/index.cfm/search-for-guides-reviews
-and-reports/?pageactiondisplayproductproductID
467.
38Future Research Needs
- Consensus is needed on outcomes that are
important to both clinicians and patients to
ensure consistency and comparability across
future studies. - Future studies should be randomized, employ a
comparison or control group where appropriate and
feasible, and ensure comparability of treatment
groups.
Seida J, et al. AHRQ Comparative Effectiveness
Review No. 22. Available at http//effectivehealt
hcare.ahrq.gov/index.cfm/search-for-guides-reviews
-and-reports/?pageactiondisplayproductproductID
467.