国产聚醚醚酮缝线锚钉用于肩袖撕裂修补的近期安全性和有效性——一项多中心、随机、单盲、平行对照的非劣效性研究

Short-term safety and effectiveness of domestic polyether-ether-ketone suture anchors for rotator cuff repair:A multicenter,randomized,single-blind,parallel-controlled noninferiority study

目的采用多中心、随机、单盲、平行对照的非劣效性研究,通过与临床常用的进口聚醚醚酮(polyether-ether-ketone,PEEK)缝线锚钉进行比较,评价国产PEEK缝线锚钉用于肩袖撕裂修补的近期安全性及有效性。方法以2019年5月—10月收治的59例肩袖撕裂患者作为研究对象,3例不符合选择标准排除以及1例因严重不良事件退出;共55例纳入研究,随机分为两组,试验组27例采用杭州锐健马斯汀医疗器材有限公司生产的PEEK缝线锚钉,对照组28例采用美国Arthrex公司的PEEK缝线锚钉;术后对照组2例失访,最终试验组27例、对照组26例纳入研究分析。两组患者性别、年龄、病程、肩袖撕裂侧别及分型、合并2型糖尿病例数以及术前肩关节美国加州大学洛杉矶分校(UCLA)评分、Constant-Murley评分、美国肩肘外科医师协会(ASES)评分、疼痛视觉模拟评分(VAS)等一般资料比较,差异均无统计学意义(P>0.05)。术后定期随访,包括安全性评价(并发症、锚钉植入位置及锚点骨反应)和临床疗效评价(肩关节功能及疼痛评分,参照Sugaya分型标准评估肩袖完整性)。结果两组手术均顺利完成,未出现手术及与缝线锚钉相关并发症;术后切口均Ⅰ期愈合。试验组随访时间为(5.85±0.77)个月,对照组为(5.96±0.72)个月,差异无统计学意义(t=0.535,P=0.595)。MRI复查示两组修复肌腱均固定在位,锚钉位置均正常且无松动、移位和撕裂;术后1 d、3个月及6个月两组均未出现锚点骨反应为3~4级患者,组间分级差异比较差异均无统计学意义(P>0.05)。术后两组患者VAS评分均呈下降趋势,ASES评分、Constant-Murley评分及UCLA评分均逐渐增加,组内各时间点间比较差异均有统计学意义(P<0.05);各时间点两组间比较,差异均无统计学意义(P>0.05)。术后1 d及3、6个月,两组肩袖完整性Sugaya分型比较差异均无统计学意义(P>0.05)。结论肩袖撕裂修补术中采用国产PEEK缝线锚钉的近期安全性及有效性与目前临床常用的进口PEEK缝线锚钉无明显差异。

Objective A multicenter,randomized,single-blind,parallel-controlled noninferiority study was used to evaluate the short-term safety and effectiveness of domestic polyether-ether-ketone(PEEK)suture anchor for rotator cuff repair by comparing with the imported PEEK suture anchor commonly used in clinical practice.Methods A total of 59 patients with rotator cuff tears who were admitted between May 2019 and October 2019 were selected as the research objects.Among them,3 patients were excluded because they did not meet the selection criteria,and 1 patient withdrew from the study because of serious adverse events.A total of 55 patients were included in the study.They were randomly divided into trial group(n=27)and control group(n=28).The trial group used PEEK suture anchors produced from REJOIN Company,and the control group used PEEK suture anchors from American Arthrex Company.Two patients in control group were lost to follow-up.Twenty-seven patients in trial group and 26 patients in control group were included in the final quantitative analysis.There was no significant difference(P>0.05)in gender,age,disease duration,side and sizes of rotator cuff tears,composition ratio of patients with type 2 diabetes,and preoperative American Shoulder and Elbow Surgeons(ASES)score,Constant-Murley score,University of California at Los Angeles(UCLA)score,and visual analogue scale(VAS)score.The patients were followed up regularly after operation.The postoperative follow-up included safety evaluation(complications,anchor position,and anchor bone reaction)and effectiveness evaluation(shoulder joint function and pain scores,rotator cuff integrity based on Sugaya classification criteria).Results The operations in both groups were successfully completed,and there was no complication related to the operation and suture anchor.All incisions healed by first intention.There was no significant difference in follow-up time between trial group[(5.85±0.77)months]and control group[(5.96±0.72)months](t=0.535,P=0.595).MRI examination indicated that the repaired tendons were fixed and the anchors did not get loose or torn.At 1 day,3 months,and 6 months after operation,there was no patient with grade 3-4 anchor bone reaction in the two groups,and there was no significant difference in the bone reaction grading between groups(P>0.05).After operation,the VAS scores of the two groups gradually decreased,and the ASES scores,Constant-Murley scores,and UCLA scores gradually increased,and there were significant differences between groups at each time point(P<0.05).There was no significant difference between groups at different time points(P>0.05).There was no significant difference in Sugaya classification of rotator cuff integrity at 1 day,3 months,and 6 months after operation between groups(P>0.05).Conclusion The short-term safety and effectiveness of domestic PEEK suture anchors in rotator cuff tear repair are not significant different from those of imported PEEK suture anchors commonly used in clinical practice.