Comparative%20Effectiveness%20of%20Nonoperative%20and%20Operative%20Treatments%20for%20Rotator%20Cuff%20Tears

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Comparative%20Effectiveness%20of%20Nonoperative%20and%20Operative%20Treatments%20for%20Rotator%20Cuff%20Tears

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Title: Comparative%20Effectiveness%20of%20Nonoperative%20and%20Operative%20Treatments%20for%20Rotator%20Cuff%20Tears

1
Comparative Effectiveness of Nonoperative and
Operative Treatments for Rotator Cuff Tears

Prepared for
Agency for Healthcare Research and Quality (AHRQ)
www.ahrq.gov

2
Overview (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.
3
Overview (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.

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.

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.

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.

7
Incidence 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.
8
Managing 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

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.

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.

11
The 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.

12
Clinical 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

Health-related quality of life
Shoulder function
Time to return to work/activities
Cuff integrity
Pain
Range of motion
Strength of the shoulder

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.
15
Rating 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.
16
Early vs. Late Operative Intervention for Rotator
Cuff Tears
17
Early 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.
18
Comparative Effectiveness of Nonoperative vs.
Operative Interventions for Rotator Cuff Tears

Five comparative studies (2 randomized controlled
trials and 3 cohort studies)

19
Comparisons 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.

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.

Three comparative studies (1 randomized
controlled trial, 2 retrospective cohort
studies).

22
Comparative 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.

Thirty-two controlled studies (5 randomized
controlled trials, 4 controlled clinical trials,
6 prospective cohort studies, 17 retrospective
cohort studies).
Thirteen operative comparisons.

24
Comparative 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

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

Fifteen comparative studies (6 randomized
controlled trials, 1 controlled clinical trial, 8
cohort studies)
Modest methodological quality

27
Comparative 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.

Eleven studies (10 comparative, 1 uncontrolled).
Most frequently studied comparison was continuous
passive motion with physical therapy vs. physical
therapy alone (3 studies).

29
Postoperative 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.

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.

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.

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

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.

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.

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.

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.

37
Gaps 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.

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.

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