Abstract
Background:
Rotator cuff repair (RCR) failure remains a persistent clinical challenge despite advances in surgical techniques. Although the subacromial bursa—historically excised during repair—is recognized for its regenerative potential due to its rich population of connective tissue progenitor cells, high-quality clinical evidence supporting its utility as an autologous biological adjunct remains lacking.
Hypothesis:
Subacromial bursa augmentation during arthroscopic RCR improves patient-reported outcomes and magnetic resonance imaging (MRI)–based tendon healing compared with standard repair.
Study Design:
Randomized controlled trial; Level of evidence, 2.
Methods:
A total of 67 patients undergoing primary arthroscopic repair for full- or near-full-thickness supraspinatus tears were randomized to receive either standard repair (control; n = 34) or repair with minced subacromial bursa reimplantation (cases; n = 33). All patients underwent identical surgical repair constructs. Patient-reported outcomes (American Shoulder and Elbow Surgeons [ASES], Simple Shoulder Test [SST], and PROMIS [Patient-Reported Outcomes Measurement Information System] Upper Extremity and Global scores) were collected at baseline and at multiple intervals up to 24 months. MRI was used to evaluate tendon integrity (Sugaya classification) and supraspinatus tendon thickness at a minimum of 6 months postoperatively. Generalized estimating equations and chi-square tests were used for longitudinal and categorical comparisons.
Results:
Patient-reported outcomes improved significantly over time in both the control and augmentation groups. While no statistically significant between-group differences were observed overall, the bursa augmentation group demonstrated a higher Global score at 6 months (P = .047). Across other time points, outcomes, including PROMIS, ASES, SST, and Global ratings, did not show significant differences. MRI analysis at 6 months reflected a similar pattern, and no significant differences were detected. A smaller proportion of patients in the augmentation group exhibited high-grade Sugaya types (3-5: 28% vs 39% in the control group), and retear dimensions were generally smaller.
Conclusion:
In this randomized clinical trial, subacromial bursa augmentation did not improve tendon healing or clinical outcomes after arthroscopic RCR. These results clearly reject the initial hypothesis that bursal augmentation enhances the healing of repair. While the procedure appeared safe and feasible, the absence of measurable benefit indicates that its routine clinical use cannot be supported at this time.
Registration:
NCT04634084 (ClinicalTrials.gov identifier).
Keywords
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