Surgery for rotator cuff disease

Background

The rotator cuff is a group of tendons that holds the shoulder joint in place allowing people to lift their arm and reach overhead. Some people can develop pain in their shoulder related to wear and tear of the rotator cuff. There may also be inflammation of the shoulder tendons or bursa (another part of the shoulder that helps it move), and pressure on the tendons by the overlying bone when lifting the arm up (impingement). Often the pain is made worse by sleeping on the affected shoulder and moving the shoulder in certain directions.

Surgery on your rotator cuff may include removing part of your bone to take the pressure off the rotator cuff tendons (acromioplasty), removing any swollen or inflamed bursa (the small sack of fluid that cushions the shoulder joint), and removing any damaged tissue or bone to widen the space where the tendons pass (subacromial decompression). Most rotator cuff surgery is now performed arthroscopically (surgical instruments are inserted through a small incision or key hole to perform surgery).

Study characteristics

This Cochrane Review is current to 22 October 2018. Trials were performed in hospitals in Denmark, Finland, Germany, Norway, Sweden and the UK. We included eight trials (1062 participants), comparing surgery with placebo (fake) surgery or other non-operative treatment, such as exercise in people with impingement of the shoulder rotator cuff tendons.

The number of participants ranged from 42 to 313, mean age from 42 to 65 years, and duration of follow-up from one year up to 12 to 13 years. Five trials failed to report funding sources, three received funding from non-commercial foundations, and one trial author was paid by an instrument company.

Key results

Two trials (506 participants) met our criteria for inclusion for our main comparison, surgery versus placebo. Subacromial decompression resulted in little benefit to people at one-year follow-up.

Pain (lower scores mean less pain):

improved by 3% (3% worse to 8% better), or 0.26 points on a zero to 10 scale

• People who had placebo rated their pain as 2.9 points

• People who had surgery rated their pain as 2.6 points

Function (0 to 100; higher scores mean better function):

improved by 3% (1% worse to 7% better) or 3 points on a zero to 100 scale

• People who had placebo rated their function as 69 points

• People who had surgery rated their function as 72 points

Treatment success (much better or no problems at all):

5% more people rated their treatment a success (5% fewer to 16% more), or five more people out of 100

• 66 out of 100 people considered treatment as successful after placebo procedure

• 71 out of 100 people considered treatment as successful after surgery

Health-related quality of life (higher scores mean better quality of life):

worsened 2% (8% worse to 4% better) or 0.02 points on a −0.59 to 1 scale

• People who had placebo rated their quality of life as 0.73 points

• People who had surgery rated their quality of life 0.71 points

Adverse events

1% fewer people (4% fewer to 3% more) had adverse events with surgery

• 4 out of 100 people reported adverse events after placebo

• 3 out of 100 people reported adverse event after surgery

Serious adverse events

No serious adverse events were reported in the trials. In observational studies the rate of serious adverse events was between 0.5% and 0.6%.

• 5 or 6 out of 1000 people had a serious adverse event after surgery

Certainty of the evidence

In people with painful shoulder impingement, high-certainty evidence shows that subacromial decompression surgery does not improve pain, function or health-related quality of life compared with placebo surgery, and moderate-certainty evidence (downgraded due to imprecision), shows no improvement in the number of people reporting treatment success. We are uncertain if surgery is associated with more adverse events compared with no surgery.

Serious adverse events including deep infection, pulmonary embolism, nerve injury, and death can occur following shoulder surgery. Although precise estimates are unknown, the risk of serious adverse events is likely less than 1% (moderate-certainty evidence, downgraded due to imprecision).

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%.

Read the full abstract...
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 strategy: 

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.

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