Patient-Reported Outcomes After Use of a Bioabsorbable Collagen Implant to Treat Partial and Full-Thickness Rotator Cuff Tears

Purpose: To collect outcomes data on patients treated with a bioinductive collagen implant designed to induce rotator cuff healing in partial-and full-thickness cuff tears and to assess the safety and efficacy of the device. Methods: Fifteen surgeons in 15 centers in the United States enrolled patients between April 2016 and August 2017 and collected standardized outcomes data. Patients 21 years of age and older, able to read and speak English, and with partial-or full-thickness tears of the rotator cuff documented by magnetic resonance imaging were included in the study. Patients were assessed preoperatively with visual analogue scale (VAS), single-assessment numeric evaluation (SANE), Veterans RAND 12-Item (VR-12), American Shoulder and Elbow Surgeons (ASES), and Western Ontario Rotator Cuff (WORC) outcomes measures. Postoperative assessment was made at 2, 6, and 12 weeks, 6 months, and 1 year. Patients underwent a standardized operative procedure with the implant. Patient demographics, comorbidities, tear types, and concomitant operative procedures were recorded. Results: Patients in both groups experienced statistically significant improvement in VAS, SANE, VR-12 PCS, ASES, and WORC scores (mean values 1.1, P < .001; 86.0, P < .001; 49.7, P < .001; 85.6, P < .001; and 84.4, P < .001 for partial tears and 1.2, P < .001; 80.7, P < .001; 45.7, P < .001; 83.8, P < .0001; and 80.1, P < .001 for full-thickness tears, respectively). For the partial tear group, average times for return to driving, work, and nonoverhead athletic activity were 14.6, 37.3, and 65.6 days, and for the full-thickness group, 24.5, 50.7, and 119.2 days, respectively. In the partial-thickness group, 84% and 83% of patients reported improvement in their VAS pain and ASES scores, respectively, that met or exceeded each measure's minimal clinically important difference. In the full-thickness group, 72% and 77% of the patients met or exceeded the minimal clinically important differences for VAS pain and ASES, respectively. Conclusion: Outcomes after repair of partial-and full-thickness rotator cuff tears using a bioinductive implant show safety and efficacy at 1-year follow-up.