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

Abstract

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; P < .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)

Primary Rotator Cuff Bridging Reconstruction Shows Better Clinical and Radiographic Results Than Revision Bridging Reconstruction

“… 16 and Bond et al., 17 which showed significant improvement in American Shoulder and Elbow Surgeons (ASES) and UCLA scores at 26 and 36 months, respectively. These finding are also in keeping with multiple other studies that have reported on outcomes following BR using dermal allograft, 15 , 18 , 19 , 20 , 21 , 30 , 34 , 35 but very few have used WORC as their primary outcome, which makes comparison of our data difficult. A prospective randomized controlled trial by Wong et al.…”

“…Human dermal allograft has been used in BR for irreparable rotator cuff tears with promising results with improved functional scores and retear rates compared to maximal repair. 15 , 16 , 17 , 18 , 19 , 20 Although most of the studies investigating this technique show improvement in pain, strength, and range of motion (ROM), there is variability in the retear rates, and few differentiate between primary and revision rotator cuff tear. 12 , 16 , 17 , 21 Further, when evaluating rotator cuff repair, revision surgery is associated with worse mid- to long-term outcomes and a 2-fold higher risk of retear when compared to primary surgery.…”

My Approach to Failed Rotator Cuff Repair

“…19 Outcome studies have demonstrated that after revision repair, patients have improvement in pain and function, [27][28][29][30][31][32][33] and increases in active shoulder forward elevation and external rotation. 28 However, the complication rate is 2-fold compared with a primary repair, with a retear rate of 32.6% to 87% [30][31][32][33][34] and a reoperation rate of 12.6% to 34.7%. 31,32 As such, augmentation techniques to optimize healing of the revision repair are becoming increasingly popular.…”

“…Studies investigating the use of bridging reconstruction in massive rotator cuff tears have shown promising results. A randomized controlled trial by Wong et al 34 showed that, compared with maximal repair, bridging allograft reconstruction was associated with superior functional scores, lower retear rates, and decreased progression to rotator cuff arthropathy. A systematic review yielded similar results, demonstrating that the use of allograft augmentation in primary repair of large to massive rotator cuff tears leads to lower retear rates, compared with primary repair alone 46 .…”

What’s New in Shoulder and Elbow Surgery

“…The optimal approach to massive cuff tears is debatable. Wong et al 3 randomized 30 patients to bridging dermal allograft reconstruction or single-row repair. At 2 years, bridging reconstruction with allograft was associated with better WORC and Disabilities of the Arm, Shoulder and Hand Questionnaire (DASH) scores, decreased progression to rotator cuff arthropathy, and maintenance of the acromiohumeral distance.…”