Ramme 2019
Ramme 2019
Background: Rotator cuff disease is a major medical and economic burden due to a growing aging population, but
management of rotator cuff tears remains controversial. We hypothesized that there is no difference in outcomes between
patients who undergo rotator cuff repair and matched patients treated nonoperatively.
Methods: After institutional review board approval, a prospective cohort of patients over 18 years of age who had a full-thickness
rotator cuff tear seen on magnetic resonance imaging (MRI) were retrospectively evaluated. After clinical evaluation, each patient
elected to undergo either rotator cuff repair or nonsurgical treatment. Demographic information was collected at enrollment,
and self-reported outcome measures (the Normalized Western Ontario Rotator Cuff Index [WORCnorm], American Shoulder and
Elbow Surgeons score [ASES], Single Assessment Numerical Evaluation [SANE], and pain score on a visual analog scale [VAS])
were collected at baseline and at 6, 12, and >24 months. The Functional Comorbidity Index (FCI) was used to assess health
status at enrollment. The size and degree of atrophy of the rotator cuff tear were classified on MRI. Propensity score analysis was
used to create rotator cuff repair and nonsurgical groups matched by age, sex, symptom duration, FCI, tear size, injury mecha-
nism, and atrophy. The Student t test, chi-square test, and regression analysis were used to compare the treatment groups.
Results: One hundred and seven patients in each group were available for analysis after propensity score matching.
There were no differences between the groups with regard to demographics or rotator cuff tear characteristics. For all
outcome measures at the time of final follow-up, the rotator cuff repair group had significantly better outcomes than the
nonsurgical treatment group (p < 0.001). At the time of final follow-up, the mean outcome scores (and 95% confidence
interval) for the surgical repair and nonsurgical treatment groups were, respectively, 81.4 (76.9, 85.9) and 68.8 (63.7,
74.0) for the WORCnorm, 86.1 (82.4, 90.3) and 76.2 (72.4, 80.9) for the ASES, 77.5 (70.6, 82.5) and 66.9 (61.0, 72.2)
for the SANE, and 14.4 (10.2, 20.2) and 27.8 (22.5, 33.5) for the pain VAS. In the longitudinal regression analysis, better
outcomes were independently associated with younger age, shorter symptom duration, and rotator cuff repair.
Conclusions: Patients with a full-thickness rotator cuff tear reported improvement in pain and functional outcome scores
with nonoperative treatment or surgical repair. However, patients who were offered and chose rotator cuff repair reported
greater improvement in outcome scores and reduced pain compared with those who chose nonoperative treatment.
Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.
R
otator cuff tears are a common shoulder disorder that patient visits per year and a $3 to $5 billion annual economic
lack a consensus treatment algorithm1-9. It has been burden in the U.S.10,11. With increases in the number of
estimated that rotator cuff tears account for 4.5 million physically active aging persons, rotator cuff disease is quickly
Disclosure: The authors indicated that no external funding was received for any aspect of this work. On the Disclosure of Potential Conflicts of Interest
forms, which are provided with the online version of the article, one or more of the authors checked “yes” to indicate that the author had a relevant financial
relationship in the biomedical arena outside the submitted work and “yes” to indicate that the author had other relationships or activities that could be
perceived to influence, or have the potential to influence, what was written in this work (http://links.lww.com/JBJS/F448).
becoming a major medical and economic burden2. Manage- who received operative treatment for a rotator cuff tear with the
ment of full-thickness rotator cuff tears remains controversial outcomes of patients who had nonoperative management. We
because of its variable presentation, ranging from an incidental hypothesized that there would be no difference in outcomes
finding to substantial pain and disability12-14. Advanced patient between these 2 groups.
age and a high body mass index (BMI) are predictors of whether
a patient will be given nonsurgical treatment15. Furthermore, Materials and Methods
patient expectation of the effectiveness of physical therapy is Michigan Shoulder Registry
predictive of the outcome of nonsurgical treatment16. Registry Enrollment
Both surgical repair and nonoperative management are
accepted treatment strategies for patients with full-thickness
rotator cuff tears. Rotator cuff repair is successful in many
T he Michigan Shoulder Registry is an institutional review
board-approved prospective shoulder cohort including
patients with a partial-thickness rotator cuff tear, a full-thickness
patients11,17-19. Nonsurgical treatment of rotator cuff tears is rec- rotator cuff tear, impingement, or tendinosis treated by 3 expe-
ognized as an alternative to surgery with high patient satisfaction rienced shoulder surgeons. Patients with a subscapularis tear,
and good clinical outcomes in selected patients2,3,5,10,20-29. However, glenohumeral osteoarthritis, a history of infection, fracture,
the unpredictability of cuff tear progression, the possibility that a inflammatory arthritis, adhesive capsulitis, or a history of
reparable tear will become irreparable, the burden of postoper- ipsilateral shoulder surgery were not eligible for enrollment.
ative recovery, and the time and cost of unsuccessful nonopera- The cohort includes 597 patients treated from July 2009 until
tive management add complexity to the treatment strategy8,26,30-33. February 2016 and includes demographic and comorbidity
Only a few clinical trials with limited sample sizes have data, magnetic resonance imaging (MRI) measurements, and
directly compared patient outcomes of operative and nonop- patient-reported outcome scores.
erative treatment of rotator cuff tears17,18,34. Propensity score
matching is a statistical method of causal inference that mini- Registry Variables
mizes the effect of confounding bias by balancing covariates in Age, sex, and BMI were recorded at enrollment. The Functional
nonrandomized studies to approximate a randomized con- Comorbidity Index (FCI) was calculated to evaluate the
trolled trial when one is not practical35. In this study, we used patient’s overall health with regard to physical function36,37. The
statistical propensity score matching, after a minimum of 2 index requires self-reporting of 18 chronic conditions ranging
years of follow-up, to compare the clinical outcomes of patients from anxiety to congestive heart failure and has been shown to
Fig. 1
Flow diagram describing patient enrollment, treatment (Tx) allocation, and propensity score analysis.
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Fig. 2
Graph depicting the relationship of the WORCnorm score over time to treatment (Tx) group. The scores for the surgical repair and nonsurgical treatment
groups were significantly different at all time points (p < 0.05). Horizontal lines in bars = median, top and bottom of bars = interquartile range, and whiskers =
maximum and minimum data points.
to influence the outcome of rotator cuff tears, including age, effect (0.8 to 1.1), very large effect (1.2 to 1.9), or huge effect
sex, symptom duration, FCI, tear size, injury mechanism, and (‡2.0)45.
rotator cuff muscle atrophy35. Patients who were unmatched by A priori power and sample size analyses were conducted
the propensity score analysis were excluded. using G*Power46. Power and sample size calculations were
based on an expected medium to large effect size (r = 0.5) for
Statistical Evaluation the difference in WORCnorm scores between the surgical repair
Statistical analysis was performed using SPSS version 25.0. and nonsurgical treatment groups that would allow both a
Comparisons between the surgical repair and nonsurgical statistically significant and clinically relevant difference to be
treatment groups for each independent variable of interest were detected. It was determined that, to detect a difference at an a
carried out with the Student t test for continuous or interval level of 0.05 and maintain a power of 0.80, it would be nec-
variables or the Mann-Whitney U test when normality was not essary to obtain 74 patients per group.
shown. The chi-square test was used to assess differences
between categorical variables. Four models were conducted Results
and analyzed using a random effects repeated-measures mixed
linear regression to examine the predictive effect of demo-
graphic and clinical factors on each outcome of interest
O f the 597 patients in the registry, 422 were evaluated,
including 200 with nonsurgical treatment and 222 with
surgical repair (Fig. 1). After propensity score analysis, 107
(WORCnorm, ASES, SANE, and pain VAS) at baseline and patients per group were matched. No patients crossed between
longitudinally. Additionally, the Cohen d effect size was cal- groups during the study period, and there were no patient-
culated and was classified as a very small effect (0.01 to 0.19), reported complications. The average times to the last follow-up
small effect (0.2 to 0.49), medium effect (0.5 to 0.79), large (and 95% confidence interval [CI]) were 2.35 (2.11, 2.59) and
TABLE III Outcome Scores at Final Follow-up (>24 Months) in Treatment Groups
Surgical Repair* (N = 107) Nonsurgical Treatment* (N = 107) P Value Cohen d (Effect Size)
TABLE V Results of Regression Analysis Evaluating Effect of Study Variables on Each Outcome Score
B (95% CI) P Value B (95% CI) P Value B (95% CI) P Value B (95% CI) P Value
Baseline
Male sex 7.0 (21.0, 15.0) 0.87 7.6 (0.1, 15.2) 0.048 22.1 (211.9, 7.8) 0.680 21.7 (210.9, 7.4) 0.712
FCI 24.8 (27.7, 21.8) 0.002 24.5 (27.3, 21.7) 0.002 21.9 (25.6, 1.7) 0.302 4.4 (1.0, 7.8) 0.011
Longitudinal
Time · age 0.1 (0.1, 0.2) 0.002 0.1 (0.1, 0.2) 0.001 0.1 (0.1, 0.2) 0.002 20.1 (20.2, 20.1) 0.043
Time · symptom duration 3.4 (0.4, 6.4) 0.028 3.2 (0.4, 6.0) 0.028 4.2 (0.4, 7.9) 0.030 23.1 (26.5, 0.4) 0.083
Time · surgery 3.7 (2.5, 5.0) <0.001 2.7 (1.5, 3.8) <0.001 4.0 (2.5, 5.5) <0.001 23.9 (25.3, 22.5) <0.001
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greater in the surgical repair group. Additionally, our longitu- higher reported pain level than our nonsurgical treatment
dinal regression analysis showed that younger age, shorter group at baseline, which may suggest that these patients were
symptom duration, and surgical repair were independently more likely to choose surgery after an informed conversation
predictive of improved outcomes over time. with a surgeon. We used propensity score analysis to approx-
Previous studies comparing operative and nonopera- imate a randomized controlled trial to minimize the effects of
tive management of rotator cuff tears have had conflicting confounding bias while maintaining a realistic method of
results. Lambers Heerspink et al. found that patients who had treatment allocation.
undergone surgical repair had significant improvements in This study was a retrospective review of a prospectively
visual analog pain and disability scores at a 1-year follow-up, collected patient cohort, which makes it susceptible to the
but no difference in functional outcomes measured with the limitations of a retrospective study. Although the shoulder
Constant-Murley score, when compared with nonoperatively registry captures many important variables, it is not all-
treated patients17. Moosmayer et al. found that, at 1-year encompassing. Items that were not included in the registry
follow-up, patients who had been treated with surgical repair included physical examination findings, biceps tendon
had significant improvements in functional outcomes mea- pathology, rotator cuff retraction, and psychosocial factors.
sured with the ASES, improved patient satisfaction, and Although we evaluated patient-reported outcome scores,
improved pain VAS scores, but no difference in SF-36 quality- there may be a difference in the physical examination find-
of-life scores, when compared with nonoperatively treated ings that individual patients consider acceptable. Biceps
patients18. Kukkonen et al. found no difference in 2-year tendon involvement, rotator cuff retraction, and psychoso-
Constant scores, pain VAS scores, or binary patient satisfac- cial factors could offer additional comparisons in future
tion scores between surgical repair and nonoperatively treated studies51. Although we evaluated rotator cuff atrophy, we did
groups34. Piper et al. performed a meta-analysis of random- not isolate traumatic rotator cuff tears, which may differ
ized controlled trials of operatively and nonoperatively trea- from chronic tears with regard to outcomes. Authors of future
ted full-thickness rotator cuff tears50. They found statistically studies should consider incorporating patient satisfaction. It
significant but not clinically important improvement in out- is possible that patients could be highly satisfied with their
comes for the operatively treated patients compared with the treatment and yet have inferior patient-reported outcome
nonoperatively treated patients. scores and vice versa.
This study was designed with the aim of improving The method of surgical repair was not standardized at the
on the methodology of previous studies. The power analysis in inception of the registry. Although our surgeons use similar
this study ensured that our sample size was large enough to arthroscopic techniques, we cannot guarantee that all proce-
perform a statistical comparison of surgical repair and nonop- dures were comparable with regard to the number of sutures
erative treatment of rotator cuff tears. Authors of previous and anchors. It is unclear if this influenced our surgical out-
studies did not perform a power analysis and sample size cal- comes. Furthermore, an MRI was not acquired at the time of
culation17. We excluded patients with concomitant diagnoses final follow-up as part of the registry, which precludes us from
thought to independently affect patient outcomes. In previous making statements regarding the status of the rotator cuff
studies, 38% to 47% of included patients had known gleno- repair at the time of final follow-up.
humeral osteoarthritis, which introduces a potential con-
founding factor affecting patient outcomes34. In our study, we Conclusions
incorporated patient comorbidities by using the FCI in the Patients with full-thickness rotator cuff tears reported
analysis. In previous studies34, the investigators did not con- improvement in pain and functional outcome scores after
sider patient comorbidity when comparing outcome scores nonoperative treatment or surgical repair. However, patients
between patients. This is problematic as patients with many who were offered and elected to undergo rotator cuff repair
comorbidities may have lower outcome scores than healthy reported greater improvement in outcome scores and
patients34. Propensity score matching allowed us to evaluate reduced pain compared with those who chose nonoperative
all rotator cuff tear sizes and all degrees of atrophy by bal- treatment.
ancing these variables in the 2 treatment groups. In previous
studies, the analysis was limited to specific tear sizes and Appendix
degrees of muscle atrophy, which limits their applicability to Supporting material provided by the authors is posted
patients with similar rotator cuff tears18. with the online version of this article as a data supplement
Our study was not a randomized controlled trial, which at jbjs.org (http://links.lww.com/JBJS/F449). n
may be a limitation. Treatment allocation was based on surgeon
equipoise and shared decision-making, which is how surgical
decisions are made. Selection bias in choosing surgical candi-
dates is appropriate and important to achieve optimal patient Austin J. Ramme, MD, PhD1
outcomes. The aim of randomized controlled trials is to re- Christopher B. Robbins, PhD1
move selection bias, but this is not realistic. It should be noted Karan A. Patel, MD1
that our surgical repair group had lower functional scores and a James E. Carpenter, MD1
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