Importance of the Topic

Rotator cuff disease is one of the most common musculoskeletal disorders [9]. According to MRI scans, as many as 54% (25/46) of asymptomatic volunteers older than 60 years of age have partial or complete tears of the rotator cuff [18]. Usually degenerative, rotator cuff tears occasionally are associated with high-velocity trauma and a more favorable prognosis [9]. Shoulder pain negatively impacts quality of life, physical function, and leads to occupational disability [21]. In the United States alone, the diagnosis and management of rotator cuff disease presents a financial burden estimated at 300,000 procedures and USD 3 billion annually [2].

Symptomatic patients typically describe pain with overhead tasks and pain with daily activities [20]. Surgical management generally is reserved for those who fail to improve with conservative treatment, which often includes a combination of subacromial débridement or decompression, débridement and/or repair of partial tears, and generally repair of full thickness tears [20]. Surgery can be performed using open surgery or arthroscopic approaches, but there has recently been a dramatic increase in the number of patients treated arthroscopically [20]. Purported advantages of arthroscopy include rapid recovery and decreased morbidity [7]. However, controversy persists with regards to optimal management of rotator cuff disease [1]. This Cochrane review evaluated all randomized and quasirandomized controlled trials of operative and nonoperative interventions for rotator cuff disease.

Upon Closer Inspection

Intention-to-treat analysis tallies the results of participants according to the group to which they were randomized, regardless of their adherence to assigned intervention [8]. The goals of intention-to-treat are to maintain the balance of prognostic factors between groups created by randomization and to include noncompliance or protocol deviations that reflect real-world treatment effectiveness [5, 16]. In this Cochrane review, 11 of 14 trials failed to perform or report intention-to-treat analyses, and one of the trials reported that a significant number of crossovers were not analyzed in their original group [15]. Failure to employ intention-to-treat analyses typically results in an inflation of the apparent benefits of treatment; because of this, in the studies included in this Cochrane review, the benefits of surgery or other invasive interventions may have been overestimated as a result of failure to use intention-to-treat approaches.

Differential expertise bias is a unique feature of surgical randomized trials that suggests the performance of a novel or alternative procedure by a less-experienced surgeon may lead to inferior outcomes [17]. Expertise-based trial designs attempt to minimize bias and improve validity, feasibility, and ethical integrity by randomizing patients between surgeons with expertise in the intervention of interest [17]. Six of the included trials found no differences in pain or function between arthroscopic and open management of rotator cuff tears, but none adequately described surgeon expertise.

Take-Home Messages

This Cochrane review finds no difference in either functional outcome scores or pain relief between surgical and active nonoperative treatment for impingement syndrome based on three of the 14 included trials at high-risk of bias. Additionally, the review further concluded that no differences exist with regards to pain or functional outcomes between open or arthroscopic subacromial decompression based on six of the 14 trials reporting this comparison.

This Cochrane review demonstrates the need for large, rigorously designed, and well-executed randomized trials [8, 19]. Significant methodological deficiencies preclude firm conclusions regarding the effectiveness of open versus arthroscopic surgical approaches and conservative management for rotator cuff disease. The results of this review are echoed in a recent American Academy of Orthopaedic Surgeons (AAOS) Clinical Practice Guideline Summary [13]. Nineteen of the 31 recommendations were inconclusive due to lack of high quality evidence.

Future studies can enhance the transparency of their methodological quality by emphasizing clear reporting [6, 11]. The Consolidated Standards of Reporting Trials statement was developed to guide the reporting of randomized controlled trials [12], and modified as the Checklist to Evaluate a Report of a Nonpharmacological Trial to address the unique methodological issues inherent to surgical trials [3] Low-quality reporting has been identified in the orthopaedic literature using these guidelines [6, 10, 14]. Clear reporting of outcomes will allow readers to appropriately evaluate bias and safeguard in future studies [4, 6, 11].

Uniform reporting of patient-important outcomes, as well as objective clinical evaluation of specific rotator cuff muscle strength, and standardized measurement of ROM have been inconsistent and will be critical to fully understand differences between groups. Clinicians must also consider variance in patient’s goals, desires, and expectations. Published studies tend to group older and younger patients together despite the fact that younger patients generally have a better prognosis and desire improved performance, whereas older patients generally desire pain relief.