Orthopedics · 2024
Interpositional Bioresorbable Scaffold-Anchor Appears Non-inferior to a Standard Anchor in the Treatment of Rotator Cuff Tears.
Equivalence TrialСтатьяНазвание и аннотация: Перевод в очереди
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Angerett Nathan, Krasney Leighann, Lutz Rex, Maurer Timothy, Michelitch Scott, Lin Albert, Kelly Matthew
Аннотация
BACKGROUND: Failure after rotator cuff repair is typically due to a loss of integrity of the bone-tendon interface. The BioWick anchor (Zimmer-Biomet) is an interpositional scaffold-anchor that was developed to improve tendon-bone healing. The purpose of this study was to determine the clinical efficacy of this novel anchor compared with a standard anchor with respect to retear rates and patient outcomes.
MATERIALS AND METHODS: We enrolled 99 patients in a double-anonymized, prospective, randomized controlled trial who underwent rotator cuff repair. Fifty patients were randomized to the novel anchor group and 49 patients were randomized to the standard anchor group. The primary outcome was rotator cuff repair integrity assessed via ultrasound at 6 months postoperatively. Secondary outcomes included visual analog scale (VAS) pain score, American Shoulder and Elbow Surgeons (ASES) score, Simple Shoulder Test (SST), strength, and active range of motion (AROM) assessed preoperatively and postoperatively at 3 and 6 months.
RESULTS: There were no statistically significant differences in demographic data, mean rotator cuff tear size, tobacco use, workers' compensation status, or operative side between the groups. At 6-month follow-up, the retear rate was 22% (n=9) for the novel anchor group vs 23% (n=10) for the standard anchor group (P=.8864). Secondary outcomes, including VAS pain score, ASES score, SST, strength, and AROM measurements, did not differ significantly between the groups at 3- or 6-month follow-up. There were no complications identified in either group.
CONCLUSION: This study did not demonstrate superior clinical improvements or decreased retear rates with the use of this novel anchor compared with a standard anchor. [Orthopedics. 2025;48(1):e33-e39.].
MATERIALS AND METHODS: We enrolled 99 patients in a double-anonymized, prospective, randomized controlled trial who underwent rotator cuff repair. Fifty patients were randomized to the novel anchor group and 49 patients were randomized to the standard anchor group. The primary outcome was rotator cuff repair integrity assessed via ultrasound at 6 months postoperatively. Secondary outcomes included visual analog scale (VAS) pain score, American Shoulder and Elbow Surgeons (ASES) score, Simple Shoulder Test (SST), strength, and active range of motion (AROM) assessed preoperatively and postoperatively at 3 and 6 months.
RESULTS: There were no statistically significant differences in demographic data, mean rotator cuff tear size, tobacco use, workers' compensation status, or operative side between the groups. At 6-month follow-up, the retear rate was 22% (n=9) for the novel anchor group vs 23% (n=10) for the standard anchor group (P=.8864). Secondary outcomes, including VAS pain score, ASES score, SST, strength, and AROM measurements, did not differ significantly between the groups at 3- or 6-month follow-up. There were no complications identified in either group.
CONCLUSION: This study did not demonstrate superior clinical improvements or decreased retear rates with the use of this novel anchor compared with a standard anchor. [Orthopedics. 2025;48(1):e33-e39.].