Abstract：
To evaluate the safety and efficacy of a next-generation, all-suture anchor in patients undergoing arthroscopic repair of rotator cuff tears, compared with that of an established solid suture anchor.
Between April 2019 and January 2021, a prospective, comparative, randomized controlled noninferiority study conducted on people with Chinese ethnicity at 3 tertiary hospitals enrolled patients (18-75 years) requiring arthroscopic treatment for rotator cuff tears. Patients were randomized into 2 cohorts receiving either all-suture anchor or solid suture anchor and followed for 12 months. The primary outcome was the Constant-Murley score at the 12-month follow-up. Magnetic resonance imaging assessments determined the rate of retear of rotator cuff repair (defined as Sugaya classification 4 and 5). Safety evaluation was performed at all follow-up points to determine the adverse events (AEs).
In total, 120 patients with rotator cuff tears (mean age, 58.3 years; 62.5% female; 60 receiving all-suture anchor) underwent treatment. Five patients were lost to follow-up. Both cohorts showed significant improvement in Constant-Murley scores between baseline and 6 months (P < .001) and between 6 and 12 months (P < .001). There were no significant differences in Constant-Murley scores between the 2 cohorts at 12 months (P = .122) after operation. The retear rate at 12 months was 5.7% and 1.9% in the all-suture and solid suture anchor cohorts, respectively (P = .618). There were 2 cases of intraoperative anchor pullout, both of which were successfully resolved. No cases of postoperative reoperation or other anchor-related AEs were reported.
The all-suture anchor offered equivalent clinical performance to an established solid suture anchor at the 12-month follow-up in patients undergoing arthroscopic repair of rotator cuff tears. The retear rate was not statistically significantly different between the 2 cohorts.
Level I, randomized controlled trial.
Between April 2019 and January 2021, a prospective, comparative, randomized controlled noninferiority study conducted on people with Chinese ethnicity at 3 tertiary hospitals enrolled patients (18-75 years) requiring arthroscopic treatment for rotator cuff tears. Patients were randomized into 2 cohorts receiving either all-suture anchor or solid suture anchor and followed for 12 months. The primary outcome was the Constant-Murley score at the 12-month follow-up. Magnetic resonance imaging assessments determined the rate of retear of rotator cuff repair (defined as Sugaya classification 4 and 5). Safety evaluation was performed at all follow-up points to determine the adverse events (AEs).
In total, 120 patients with rotator cuff tears (mean age, 58.3 years; 62.5% female; 60 receiving all-suture anchor) underwent treatment. Five patients were lost to follow-up. Both cohorts showed significant improvement in Constant-Murley scores between baseline and 6 months (P < .001) and between 6 and 12 months (P < .001). There were no significant differences in Constant-Murley scores between the 2 cohorts at 12 months (P = .122) after operation. The retear rate at 12 months was 5.7% and 1.9% in the all-suture and solid suture anchor cohorts, respectively (P = .618). There were 2 cases of intraoperative anchor pullout, both of which were successfully resolved. No cases of postoperative reoperation or other anchor-related AEs were reported.
The all-suture anchor offered equivalent clinical performance to an established solid suture anchor at the 12-month follow-up in patients undergoing arthroscopic repair of rotator cuff tears. The retear rate was not statistically significantly different between the 2 cohorts.
Level I, randomized controlled trial.
摘要：
目的：本研究旨在评估下一代的安全性和有效性，全缝合锚钉在肩袖撕裂关节镜修复患者中，与已建立的固体缝合锚钉相比。
方法：2019年4月至2021年1月，前瞻性，比较,在三家三级医院对中国民族进行的随机对照非劣效性研究纳入了需要关节镜治疗的肩袖撕裂患者(18~75岁).患者被随机分为两组，接受全缝合锚钉或固体缝合锚钉。并随访了12个月。主要结果是12个月随访时的Constant-Murley评分。MRI评估确定了肩袖修复的再撕裂率（定义为Sugaya分类4和5）。在所有随访点进行安全性评价以确定不良事件(AE)。
结果：120例肩袖撕裂患者（平均年龄，58.3年；62.5%为女性；60名接受全缝合锚钉）接受治疗。5例患者失访。两个队列均显示基线和6个月之间Constant-Murley评分显着改善（p<0.001），6至12个月（p<0.001）。两组患者术后12个月Constant-Murley评分差异无统计学意义(p=0.122)。12个月的再撕裂率分别为5.7%和1.9%，在所有缝合和固体缝合锚组群中，分别为(P=0.618)。术中锚钉拔出2例，两者都成功解决了。无术后再手术或其他锚钉相关不良事件报告。
结论：在接受肩袖撕裂关节镜修复的患者中，在12个月的随访中，全缝合锚钉的临床性能与已建立的固体缝合锚钉的临床性能相当。两组之间的再撕裂率在统计学上没有显着差异。
方法：2019年4月至2021年1月，前瞻性，比较,在三家三级医院对中国民族进行的随机对照非劣效性研究纳入了需要关节镜治疗的肩袖撕裂患者(18~75岁).患者被随机分为两组，接受全缝合锚钉或固体缝合锚钉。并随访了12个月。主要结果是12个月随访时的Constant-Murley评分。MRI评估确定了肩袖修复的再撕裂率（定义为Sugaya分类4和5）。在所有随访点进行安全性评价以确定不良事件(AE)。
结果：120例肩袖撕裂患者（平均年龄，58.3年；62.5%为女性；60名接受全缝合锚钉）接受治疗。5例患者失访。两个队列均显示基线和6个月之间Constant-Murley评分显着改善（p<0.001），6至12个月（p<0.001）。两组患者术后12个月Constant-Murley评分差异无统计学意义(p=0.122)。12个月的再撕裂率分别为5.7%和1.9%，在所有缝合和固体缝合锚组群中，分别为(P=0.618)。术中锚钉拔出2例，两者都成功解决了。无术后再手术或其他锚钉相关不良事件报告。
结论：在接受肩袖撕裂关节镜修复的患者中，在12个月的随访中，全缝合锚钉的临床性能与已建立的固体缝合锚钉的临床性能相当。两组之间的再撕裂率在统计学上没有显着差异。
