Patient-reported outcomes after use of a bioabsorbable collagen implant to treat partial and full-thickness rotator cuff tears
Arthroscopy Jul 30, 2019
McIntyre LF, et al. - Subjects 21 years of age and older, who were able to read and speak English, and with partial- or full-thickness tears of the rotator cuff documented by magnetic resonance imaging were analyzed by the researchers in order to collect outcomes data on subjects treated with a bioinductive collagen implant designed to provoke rotator cuff healing in partial- and full-thickness cuff tears and to evaluate the safety and effectiveness of the device. 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 were used to evaluate patients, postoperatively. A statistically notable improvement in VAS, SANE, VR-12 PCS, ASES, and WORC scores was observed in both groups. For the partial tear group and for the full-thickness group, average times for return to driving, work, and nonoverhead athletic activity were 14.6, 37.3, and 65.6 days and 24.5, 50.7, and 119.2 days, respectively. In the partial-thickness group, 84% and 83% of subjects reported betterment in their VAS pain and ASES scores, respectively, that met or exceeded each measure's minimal clinically significant variation, whereas in the full-thickness group, 72% and 77% of the subjects met or exceeded the minimal clinically significant variations for VAS pain and ASES, respectively. Hence, at 1-year follow-up, outcomes following repair of partial- and full-thickness rotator cuff tears using a bioinductive implant exhibited safety and efficiency.
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