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20100705

Comparative Effectiveness of Nonoperative and Operative Treatments for Rotator Cuff Tears Part 4

Results

Description of Included Studies

The search strategy identified 5,677 citations; 137 unique studies met the eligibility criteria and were included in the review. The studies included 27 trials, 39 cohort studies, and 71 uncontrolled studies. The number of participants in the studies ranged from 12 to 224 (median=55 [IQR: 33 to 93]). The mean age of study participants ranged from 41.2 to 80 years.


Methodological Quality of Included Studies

All the randomized controlled trials and controlled clinical trials were considered to have a high risk of bias. The most common sources of potential bias were inadequate blinding, inadequate allocation concealment, and incomplete outcome data. The methodological quality of the cohort studies was moderate, with a median score of 5 stars on a possible score of 8 stars (IQR: 4 to 6). Common weaknesses in the design of the studies included lack of independent blind outcome assessment and failure to control adequately for potential confounding factors. Uncontrolled studies generally had moderate quality, with consecutive enrollment, adequate followup, and standardized outcome assessment being reported in 63 percent, 77 percent, and 44 percent of studies, respectively. Across all studies, a source of funding was rarely reported (n=49, 36 percent).

Results of Included Studies

The results of the included studies are presented by the key question(s) they address. A table with the summary of findings for nonoperative and operative interventions is presented below.

Key Question 1: Early versus late surgical repair. One study compared early surgical repair versus late surgical repair after failed nonoperative treatment. Patients receiving early surgery had superior function compared with the delayed surgical group; however, the level of significance was not reported.

Key Question 2: Comparative effectiveness of operative interventions and postoperative rehabilitation. A total of 113 studies examined the effectiveness of operative interventions, while 11 studies evaluated postoperative rehabilitation protocols following surgery. A median of 55 patients (IQR: 34 to 95) with a median age of 58.6 years (IQR: 55.5 to 61.7) were included in the operative studies. Males comprised an average of 64.6 percent of study participants. For postoperative rehabilitation, studies included a median of 61 participants (IQR: 36 to 79.5) with a median age of 58.0 years (IQR: 56.3 to 60.8). Males comprised an average of 58.9 percent of study participants.

Studies assessing operative treatments were categorized as focusing on an operative approach (e.g., open, mini-open, arthroscopic, and debridement), technique (i.e., suture or anchor type or configuration) or augmentation for RC repair. The majority of surgical studies (32 comparative studies and 58 uncontrolled studies) evaluated operative approaches. The comparative studies provided moderate evidence indicating no statistical or clinically important differences in function between open and mini-open repairs; however, there was some evidence suggesting an earlier return to work by approximately 1 month for mini-open repairs. Similarly, there was moderate evidence demonstrating no difference in function between mini-open and arthroscopic repair and arthroscopic repair with and without acromioplasty. There was moderate evidence for greater improvement in function for open repairs compared with arthroscopic debridement. The strength of evidence was low for the remaining comparisons and outcomes examined in the studies, precluding any conclusions regarding their comparative effectiveness. The uncontrolled studies consistently reported functional improvement from preoperative to postoperative scores, regardless of the type of approach used (open, mini-open, or arthroscopic), the study design, the sample size of the study, or the type of outcome measure used.

Operative techniques were examined in 15 comparative studies. Six studies compared single-row versus double-row fixation of repairs, providing moderate evidence of no clinically significant difference in function and no difference in cuff integrity. There was moderate evidence for no difference in cuff integrity between mattress locking and simple stitch. The evidence was too limited to make conclusions about the other techniques.

Eight studies, including three comparative and five uncontrolled studies, assessed augmentations for operative repair. The three comparative studies were relatively small and no overall conclusions were possible. Although the five uncontrolled studies evaluated different types of augmentation, they all indicated improvement in functional score from baseline to final followup.

Of the 11 postoperative rehabilitation studies (10 comparative, 1 uncontrolled), 3 compared continuous passive motion with physical therapy versus physical therapy alone. These three studies provided moderate evidence of no clinically important or statistically significant difference in function, but some evidence for earlier return to work with continuous passive motion. Each of the remaining studies examined different rehabilitation protocols; therefore, the evidence was too limited to make any conclusions regarding their comparative effectiveness.

Key Question 3: Comparative effectiveness of nonoperative interventions. Nonoperative interventions were examined in three comparative and seven uncontrolled studies. The studies included a median of 42 patients (IQR: 25.3 to 73.3), with a median age of 61 years (IQR: 60.4 to 61.5). Males comprised an average of 50 percent of participants. Each of the comparative studies assessed different interventions, including: sodium hyaluraonate versus dexamethasone; rehabilitation versus no rehabilitation (not otherwise specified); and physical therapy, oral medications, and steroid injection versus physical therapy, oral medications, and no steroid injection. The limited evidence precludes conclusions of comparative effectiveness. The degree of improvement in functional outcome scores varied considerably across the uncontrolled studies.

Key Question 4: Comparative effectiveness of nonoperative versus operative interventions. Five studies compared nonoperative to operative treatments, with a median sample size of 103 (IQR: 40 to 108). The mean ages in the studies ranged from 46.8 to 64.8 years. Males represented 55 percent of study participants. The interventions varied across studies, but generally the nonoperative arms included components such as steroid injection, stretching, and strengthening and were compared with open repair or debridement. The evidence was too limited to make conclusions regarding the comparative effectiveness of the interventions.

Key Question 5: Complications. A total of 85 studies provided data on 34 different complications of nonoperative, operative, and postoperative rehabilitation interventions. Complications were poorly reported, with studies providing limited information on how complications were defined and assessed. In 21 studies, it was reported that no complications occurred during the course of the study. In general, the rates of complication were low and the majority of complications were not deemed to be clinically important or were reported in few studies.

Key Question 6: Prognostic factors. Overall, 72 of the 137 studies examined the impact of prognostic factors on patient outcomes. General conclusions are limited, due to the varied methodologies across studies, particularly the different outcomes for which prognostic factors were evaluated. There is some evidence that tear size, age, and extent of preoperative symptoms may modify outcomes; while, workers’ compensation board (WCB) status, sex, and duration of symptoms generally showed no significant impact.

The following table summarizes the findings of the studies and indicates the overall strength of the evidence on each topic examined.

Summary of strength of evidence for nonoperative and operative interventions for RC tears



See Summary of strength of evidence for nonoperative and operative interventions for RC tears

Source: Summary of strength of evidence for nonoperative and operative interventions for RC tears

Table of Contents

Comparative Effectiveness of Nonoperative and Operative Treatments for Rotator Cuff Tears



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