Bridging Allograft Reconstruction Is Superior to Maximal Repair for the Treatment of Chronic, Massive Rotator Cuff Tears: Results of a Prospective, Randomized Controlled Trial.

Background: Despite advances in surgical techniques, the use of maximal repair to treat large or massive rotator cuff tears results in a high retear rate postoperatively. Currently, no randomized controlled trials have compared the outcomes of maximal repair with interposition dermal allograft bridging reconstruction.

Hypothesis: We hypothesized that large or massive rotator cuff tendon tears reconstructed using bridging dermal allograft would have better clinical outcomes 2 years postoperatively, as measured using the Western Ontario Rotator Cuff (WORC) index, than would those receiving the current gold standard treatment of debridement and maximal repair alone. We also expected that patients treated via bridging reconstruction using dermal allograft would have fewer postoperative failures as assessed using postoperative magnetic resonance imaging scans.

Study Design: Randomized controlled trial; Level of evidence 1.

Methods: A sample size of 30 patients (determined using a priori sample size calculation) with massive, retracted rotator cuff tears were randomly allocated to 1 of 2 groups: maximal repair or bridging reconstruction using dermal allograft. All patients completed questionnaires (WORC and Disabilities of the Arm, Shoulder and Hand [DASH]) preoperatively and postoperatively at 3 months, 6 months, 1 year, and 2 years. The primary outcome of this study was the WORC index at 2 years. Secondary outcomes included healing rate, progression of rotator cuff arthropathy, and postoperative acromiohumeral distance in both groups.

Results: Patients treated via bridging reconstruction using dermal allograft had better postoperative WORC and DASH scores (23.93 ± 24.55 and 15.77 ± 19.27, respectively) compared with patients who received maximal repair alone (53.36 ± 31.93 and 34.32 ± 23.31, respectively). We also noted increased progression to rotator cuff arthropathy in the maximal repair group with an increased retear rate when compared with the reconstruction group (87% and 21%, respectively; < .001). The acromiohumeral distance was maintained in the reconstruction group but significantly decreased in the maximal repair group.

Conclusion: Rotator cuff bridging reconstruction using a dermal allograft demonstrated improved patient-reported outcomes as measured using the WORC index 2 years postoperatively. This technique also showed favorable structural healing rates and decreased progression to arthropathy compared with maximal repair.

Trial Registration: ClinicalTrials.gov (NCT01987973).