Clinical and Anatomical Outcomes of Arthroscopic Repair of Large Rotator Cuff Tears with Allograft Patch Augmentation: A Prospective, Single-Blinded, Randomized Controlled Trial with a Long-term Follow-up

BACKGROUND: Arthroscopic rotator cuff repair using human dermal matrix allograft augmentation has been widely used. We assessed the effect of acellular human dermal matrix augmentation after arthroscopic repair of large rotator cuff tears through a prospective, single-blinded, randomized controlled trial with a long-term follow-up. METHODS: Sixty patients with large-sized rotator cuff tears were randomly assigned to two groups. Patients in the control group underwent arthroscopic rotator cuff repair. Allograft patch augmentation was additionally performed in the allograft group. All patients were subdivided into a complete coverage (CC) group or an incomplete coverage (IC) group according to footprint coverage after cuff repair. Constant and American Shoulder and Elbow Surgeons (ASES) scores were assessed preoperatively and at final follow-up. Magnetic resonance imaging was also performed at the same time to evaluate the anatomical results. RESULTS: Forty-three patients were followed up for an average of 5.7 years. Clinical scores (Constant and ASES) increased significantly at the last follow-up in both groups. The increase in ASES score in the allograft group was statistically significantly greater than that in the control group. The degree of Constant score improvement did not differ significantly between the two groups. The retear rate was 9.1% in the allograft group, which was significantly lower than that in the control group (38.1%). In the control group, the CC subgroup had a statistically significantly lower retear rate (16.7%) than did the IC subgroup. There were no retear cases in the CC subgroup of the allograft group. CONCLUSIONS: Long-term follow-up of arthroscopic repair of large rotator cuff tears with allograft patch augmentation showed better clinical and anatomical results. Footprint coverage after rotator cuff repair was an important factor affecting the retear rate. If the footprint was not completely covered after rotator cuff repair, allograft patch augmentation may reduce the retear rate.