Surgery for rotator cuff tears.

BACKGROUND: This review is one in a series of Cochrane Reviews of interventions for shoulder disorders. OBJECTIVES: To synthesise the available evidence regarding the benefits and harms of rotator cuff repair with or without subacromial decompression in the treatment of rotator cuff tears of the shoulder. SEARCH METHODS: We searched the CENTRAL, MEDLINE, Embase, Clinicaltrials.gov and WHO ICRTP registry unrestricted by date or language until 8 January 2019. SELECTION CRITERIA: Randomised controlled trials (RCTs) including adults with full-thickness rotator cuff tears and assessing the effect of rotator cuff repair compared to placebo, no treatment, or any other treatment were included. As there were no trials comparing surgery with placebo, the primary comparison was rotator cuff repair with or without subacromial decompression versus non-operative treatment (exercises with or without glucocorticoid injection). Other comparisons were rotator cuff repair and acromioplasty versus rotator cuff repair alone, and rotator cuff repair and subacromial decompression versus subacromial decompression alone. Major outcomes were mean pain, shoulder function, quality of life, participant-rated global assessment of treatment success, adverse events and serious adverse events. The primary endpoint for this review was one year. DATA COLLECTION AND ANALYSIS: We used standard methodologic procedures expected by Cochrane. MAIN RESULTS: We included nine trials with 1007 participants. Three trials compared rotator cuff repair with subacromial decompression followed by exercises with exercise alone. These trials included 339 participants with full-thickness rotator cuff tears diagnosed with magnetic resonance imaging (MRI) or ultrasound examination. One of the three trials also provided up to three glucocorticoid injections in the exercise group. All surgery groups received tendon repair with subacromial decompression and the postoperative exercises were similar to the exercises provided for the non-operative groups. Five trials (526 participants) compared repair with acromioplasty versus repair alone; and one trial (142 participants) compared repair with subacromial decompression versus subacromial decompression alone. The mean age of trial participants ranged between 56 and 68 years, and females comprised 29% to 56% of the participants. Symptom duration varied from a mean of 10 months up to 28 months. Two trials excluded tears with traumatic onset of symptoms. One trial defined a minimum duration of symptoms of six months and required a trial of conservative therapy before inclusion. The trials included mainly repairable full-thickness supraspinatus tears, six trials specifically excluded tears involving the subscapularis tendon. All trials were at risk of bias for several criteria, most notably due to lack of participant and personnel blinding, but also for other reasons such as unclearly reported methods of random sequence generation or allocation concealment (six trials), incomplete outcome data (three trials), selective reporting (six trials), and other biases (six trials). Our main comparison was subacromial decompression versus non-operative treatment and results are reported for the 12 month follow up. At one year, moderate-certainty evidence (downgraded for bias) from 3 trials with 258 participants indicates that surgery probably provides little or no improvement in pain; mean pain (range 0 to 10, higher scores indicate more pain) was 1.6 points with non-operative treatment and 0.87 points better (0.43 better to 1.30 better) with surgery.. Mean function (zero to 100, higher score indicating better outcome) was 72 points with non-operative treatment and 6 points better (2.43 better to 9.54 better) with surgery (3 trials; 269 participants), low-certainty evidence (downgraded for bias and imprecision). Participant-rated global success rate was 873/1000 after non-operative treatment and 943/1000 after surgery corresponding to (risk ratio (RR) 1.08, 95% confidence interval (CI) 0.96 to 1.22; low-certainty evidence (downgraded for bias and imprecision). Health-related quality of life was 57.5 points (SF-36 mental component score, 0 to 100, higher score indicating better quality of life) with non-operative treatment and 1.3 points worse (4.5 worse to 1.9 better) with surgery (1 trial; 103 participants), low-certainty evidence (downgraded for bias and imprecision). We were unable to estimate the risk of adverse events and serious adverse events as only one event was reported across the trials (very low-certainty evidence; downgraded once due to bias and twice due to very serious imprecision). AUTHORS' CONCLUSIONS: At the moment, we are uncertain whether rotator cuff repair surgery provides clinically meaningful benefits to people with symptomatic tears; it may provide little or no clinically important benefits with respect to pain, function, overall quality of life or participant-rated global assessment of treatment success when compared with non-operative treatment. Surgery may not improve shoulder pain or function compared with exercises, with or without glucocorticoid injections. The trials included have methodology concerns and none included a placebo control. They included participants with mostly small degenerative tears involving the supraspinatus tendon and the conclusions of this review may not be applicable to traumatic tears, large tears involving the subscapularis tendon or young people. Furthermore, the trials did not assess if surgery could prevent arthritic changes in long-term follow-up. Further well-designed trials in this area that include a placebo-surgery control group and long follow-up are needed to further increase certainty about the effects of surgery for rotator cuff tears.

Subacromial decompression surgery for rotator cuff disease.

BACKGROUND: Surgery for rotator cuff disease is usually used after non-operative interventions have failed, although our Cochrane Review, first published in 2007, found that there was uncertain clinical benefit following subacromial decompression surgery. OBJECTIVES: To synthesise the available evidence of the benefits and harms of subacromial decompression surgery compared with placebo, no intervention or non-surgical interventions in people with rotator cuff disease (excluding full thickness rotator cuff tears). SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, Clinicaltrials.gov and WHO ICRTP registry from 2006 until 22 October 2018, unrestricted by language. SELECTION CRITERIA: We included randomised and quasi-randomised controlled trials (RCTs) of adults with rotator cuff disease (excluding full-thickness tears), that compared subacromial decompression surgery with placebo, no treatment, or any other non-surgical interventions. As it is least prone to bias, subacromial decompression compared with placebo was the primary comparison. Other comparisons were subacromial decompression versus exercises or non-operative treatment. Major outcomes were mean pain scores, shoulder function, quality of life, participant global assessment of success, adverse events and serious adverse events. The primary endpoint for this review was one year. For serious adverse events, we also included data from prospective cohort studies designed to record harms that evaluated subacromial decompression surgery or shoulder arthroscopy. DATA COLLECTION AND ANALYSIS: We used standard methodologic procedures expected by Cochrane. MAIN RESULTS: We included eight trials, with a total of 1062 randomised participants with rotator cuff disease, all with subacromial impingement. Two trials (506 participants) compared arthroscopic subacromial decompression with arthroscopy only (placebo surgery), with all groups receiving postoperative exercises. These trials included a third treatment group: no treatment (active monitoring) in one and exercises in the other. Six trials (556 participants) compared arthroscopic subacromial decompression followed by exercises with exercises alone. Two of these trials included a third arm: sham laser in one and open subacromial decompression in the other.Trial size varied from 42 to 313 participants. Participant mean age ranged between 42 and 65 years. Only two trials reported mean symptom duration (18 to 22 months in one trial and 30 to 31 months in the other), two did not report duration and four reported it categorically.Both placebo-controlled trials were at low risk of bias for the comparison of surgery versus placebo surgery. The other trials were at high risk of bias for several criteria, most notably at risk of performance or detection bias due to lack of participant and personnel blinding. We have restricted the reporting of results of benefits in the Abstract to the placebo-controlled trials.Compared with placebo, high-certainty evidence indicates that subacromial decompression provides no improvement in pain, shoulder function, or health-related quality of life up to one year, and probably no improvement in global success (moderate-certainty evidence, downgraded due to imprecision).At one year, mean pain (on a scale zero to 10, higher scores indicate more pain), was 2.9 points after placebo surgery and 0.26 better (0.84 better to 0.33 worse), after subacromial decompression (284 participants), an absolute difference of 3% (8% better to 3% worse), and relative difference of 4% (12% better to 5% worse). At one year, mean function (on a scale 0 to 100, higher score indicating better outcome), was 69 points after placebo surgery and 2.8 better (1.4 worse to 6.9 better), after surgery (274 participants), an absolute difference of 3% (7% better to 1% worse), and relative difference of 9% (22% better to 4% worse). Global success rate was 97/148 (or 655 per 1000), after placebo and 101/142 (or 708 per 1000) after surgery corresponding to RR 1.08 (95% CI 0.93 to 1.27). Health-related quality of life was 0.73 units (European Quality of Life EQ-5D, -0.59 to 1, higher score indicating better quality of life), after placebo and 0.03 units worse (0.011 units worse to 0.06 units better), after subacromial decompression (285 participants), an absolute difference of 1.3% (5% worse to 2.5% better), and relative difference of 4% (15% worse to 7% better).Adverse events including frozen shoulder or transient minor complications of surgery were reported in approximately 3% of participants across treatment groups in two randomised controlled trials, but due to low event rates we are uncertain if the risks differ between groups: 5/165 (37 per 1000) reported adverse events with subacromial decompression and 9/241 (34 per 1000) with placebo or non-operative treatment, RR 0.91 (95% CI 0.31 to 2.65) (moderate-certainty evidence, downgraded due to imprecision). The trials did not report serious adverse events.Based upon moderate-certainty evidence from two observational trials from the same prospective surgery registry, which also included other shoulder arthroscopic procedures (downgraded for indirectness), the incidence proportion of serious adverse events within 30 days following surgery was 0.5% (0.4% to 0.7%; data collected 2006 to 2011), or 0.6% (0.5 % to 0.7%; data collected 2011 to 2013). Serious adverse events such as deep infection, pulmonary embolism, nerve injury, and death have been observed in participants following shoulder surgery. AUTHORS' CONCLUSIONS: The data in this review do not support the use of subacromial decompression in the treatment of rotator cuff disease manifest as painful shoulder impingement. High-certainty evidence shows that subacromial decompression does not provide clinically important benefits over placebo in pain, function or health-related quality of life. Including results from open-label trials (with high risk of bias) did not change the estimates considerably. Due to imprecision, we downgraded the certainty of the evidence to moderate for global assessment of treatment success; there was probably no clinically important benefit in this outcome either compared with placebo, exercises or non-operative treatment.Adverse event rates were low, 3% or less across treatment groups in the trials, which is consistent with adverse event rates reported in the two observational studies. Although precise estimates are unknown, the risk of serious adverse events is likely less than 1%.

Physical therapy versus natural history in outcomes of rotator cuff tears: the Rotator Cuff Outcomes Workgroup (ROW) cohort study.

BACKGROUND: We compared the outcomes of patients who performed physical therapy versus those who did not in a longitudinal cohort of patients undergoing nonoperative treatment of rotator cuff tears. We also assessed whether there was a dose effect in which the pain and functional outcomes in patients performing physical therapy plateaued. METHODS: From February 2011 to June 2015, a multicenter cohort of patients with rotator cuff tears undergoing nonoperative treatment completed a detailed health and demographic questionnaire and the Shoulder Pain and Disability Index (SPADI) at baseline and 3, 6, 12, and 18 months. Longitudinal mixed models were used to assess whether physical therapy in the first 3 months predicted SPADI scores and dose effect. RESULTS: Among the 55 patients in our cohort, the performance of physical therapy within the first 3 months predicted better SPADI scores versus nonperformance of physical therapy at 3 months (P = .02). Scores were similar between groups at 6, 12, and 18 months. A threshold of 16 physical therapy sessions was observed for pain and functional improvement during follow-up, after which significant improvement was not seen. CONCLUSIONS: Patients who performed physical therapy within the first 3 months had statistically significant improvements in pain and function as measured by the SPADI score at 3 months compared with patients who did not report performing physical therapy. Depending on the minimal clinically important difference used for the SPADI score, our results could be interpreted as meeting the minimal clinically important difference threshold or not. Improvement in outcomes was observed up to 16 sessions of physical therapy, after which outcomes plateaued.