Northwell Physician Partners, Sleepy Hollow, New York, U.S.A..
Associated Orthopedists of Detroit, St. Clair Shores, Michigan, U.S.A.
Arthroscopy. 2019 Aug;35(8):2262-2271. doi: 10.1016/j.arthro.2019.02.019. Epub 2019 Jul 23.
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.
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.
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.
Outcomes after repair of partial- and full-thickness rotator cuff tears using a bioinductive implant show safety and efficacy at 1-year follow-up.
Retrospective case series, level IV evidence.
收集使用生物诱导胶原植入物治疗部分和全层肩袖撕裂患者的结果数据，并评估该设备的安全性和有效性。
美国 15 个中心的 15 位外科医生于 2016 年 4 月至 2017 年 8 月期间入组患者，并收集标准化的结果数据。本研究纳入了年龄在 21 岁及以上、能够阅读和说英语且磁共振成像（MRI）显示有部分或全层肩袖撕裂的患者。患者在术前接受视觉模拟量表（VAS）、单一评估数字评估（SANE）、退伍军人 RAND 12 项（VR-12）、美国肩肘外科医生协会（ASES）和西部安大略省肩袖（WORC）评估。术后 2、6 和 12 周、6 个月和 1 年进行评估。患者接受了植入物的标准化手术。记录患者的人口统计学资料、合并症、撕裂类型和同时进行的手术操作。
两组患者的 VAS、SANE、VR-12 PCS、ASES 和 WORC 评分均有统计学意义的改善（部分撕裂组的平均数值分别为 1.1，P <.001；86.0，P <.001；49.7，P <.001；85.6，P <.001；和 84.4，P <.001；全层撕裂组分别为 1.2，P <.001；80.7，P <.001；45.7，P <.001；83.8，P <.0001；和 80.1，P <.001）。部分撕裂组中，患者恢复驾驶、工作和非上肢运动活动的平均时间分别为 14.6、37.3 和 65.6 天，而全层撕裂组分别为 24.5、50.7 和 119.2 天。在部分撕裂组中，84%和 83%的患者报告 VAS 疼痛和 ASES 评分的改善达到或超过每个评分的最小临床重要差异。在全层撕裂组中，72%和 77%的患者 VAS 疼痛和 ASES 的最小临床重要差异。
使用生物诱导植入物修复部分和全层肩袖撕裂的结果在 1 年随访时显示出安全性和有效性。
回顾性病例系列，IV 级证据。
