全缝线锚钉与带线锚钉治疗肩袖撕裂有效性和安全性的前瞻性随机对照研究  

Effectiveness and safety of all-suture anchors and single-row suture anchors for rotator cuff repair:a prospective randomized controlled study

作　　者：方晶华 汪斯衡 朱苏南[1] 祝磊波[1] 余新宁[1] 宋红云[1] 戴雪松[1] Fang Jinghua;Wang Siheng;Zhu Sunan;Zhu Leibo;Yu Xinning;Song Hongyun;Dai Xuesong(Department of Orthopedic Surgery,Second Affiliated Hospital,Zhejiang University School of Medicine,Orthopedic Research Institute of Zhejiang University,Key Laboratory of Motor System Disease Research and Precision Therapy of Zhejiang Province,Clinical Research Center of Motor System Disease of Zhejiang Province,Hangzhou 310000,China)

机构地区：[1]浙江大学医学院附属第二医院骨科,浙江大学骨科研究所,浙江省运动系统疾病研究与精准诊治重点实验室,浙江省运动系统疾病临床医学研究中心,杭州310000

出　　处：《中华创伤杂志》2023年第12期1086-1093,共8页Chinese Journal of Trauma

摘　　要：目的比较全缝线锚钉与带线锚钉修复肩袖撕裂的有效性和安全性。方法采用前瞻性随机对照研究分析2019年7月至2021年9月浙江大学医学院附属第二医院收治的50例肩袖撕裂患者的临床资料。根据随机分配表将肩袖撕裂患者分为两组:25例采用带线锚钉单排缝合肩袖(对照组),25例采用全缝线锚钉单排缝合肩袖(试验组)。比较两组术前、术后3个月及末次随访时视觉模拟评分(VAS)、美国加州大学洛杉矶分校(UCLA)肩关节评分、美国肩肘外科协会(ASES)评分和肩关节活动度。术后6个月,根据Sugaya分级标准评定两组肩袖再撕裂率情况。观察两组术中锚钉断裂、松动情况;术后切口愈合情况、感染或神经系统并发症;术后3、6个月锚钉位置变化和置入点骨反应情况。结果共纳入肩袖撕裂患者50例,其中男17例,女33例;年龄40~73岁[(59.1±10.3)岁]。患者均获随访6~9个月[(6.7±1.0)个月]。术前两组VAS、UCLA肩关节评分、ASES评分及肩关节活动度差异无统计学意义(P均>0.05)。术后3个月及末次随访时对照组VAS分别为2.0(2.0,4.0)分、2.0(0.0,2.0)分,试验组分别为2.0(2.0,2.0)分、2.0(0.0,2.0)分(P均>0.05)。术后3个月对照组UCLA肩关节评分、ASES评分及末次随访时ASES评分分别为(25.1±4.5)分、78.8(71.6,85.8)分、85.8(85.8,93.0)分,试验组分别为(26.8±4.7)分、85.8(82.3,85.8)分、92.8(85.8,100.0)分(P均>0.05)。末次随访时对照组UCLA肩关节评分为(29.2±3.9)分,低于试验组的(31.6±2.4)分(P<0.05)。术后3个月及末次随访时两组患者肩关节活动度差异无统计学意义(P均>0.05)。两组术后3个月及末次随访时VAS、UCLA肩关节评分、ASES评分分别较术前显著改善(P均<0.05),且末次随访时较术后3个月进一步改善(P均<0.05)。术后6个月对照组肩袖再撕裂率为16.7%(4/24),试验组为4.3%(1/23)(P>0.05)。术中无锚钉松动、断裂等。术后切口均Ⅰ期愈合,无感染或神经系Objective To compare the effectiveness and safety of all-suture anchors and single-row suture anchors for rotator cuff repair.Methods A prospective randomized controlled study was conducted to analyze the clinical data of 50 patients with rotator cuff tear admitted to Second Affiliated Hospital of Zhejiang University School of Medicine between July 2019 and September 2021.They were divided into two groups according to the random table:25 patients to receive repair with single-row suture anchors(control group)and the other 25 with all-suture anchors(trial group).Visual Analogue Scale(VAS),University of California,Los Angeles(UCLA)shoulder score,American Shoulder and Elbow Surgeons(ASES)score and shoulder range of motion were compared between the two groups before surgery,at 3 months after surgery and at the last follow-up.The rotator cuff retear rate of the two groups was evaluated according to Sugaya classification at 6 months after surgery.Breakage or anchor loosening during surgery,healing of incision and presence of infections or neurological complications after surgery,and change of the anchor position and periosteal reaction at the insertion site at 3 and 6 months after surgery were observed in the two groups.Results A total of 50 patients with rotator cuff tear were involved in this study,including 17 males and 33 females,aged 40-73 years[(59.1±10.3)years].All patients were followed up for 6-9 months[(6.7±1.0)months].The differences in VAS,UCLA shoulder score,ASES score,and shoulder range of motion between the two groups were statistically insignificant before surgery(all P>0.05).The VAS at 3 months after surgery and at the last follow-up in the control group was 2.0(2.0,4.0)points and 2.0(0.0,2.0)points,respectively,with no statistical differences from 2.0(2.0,2.0)points and 2.0(0.0,2.0)points in the trial group(all P>0.05).In the control group,the UCLA shoulder score and ASES score at 3 months after surgery and the ASES score at the last follow-up were(25.1±4.5)points,78.8(71.6,85.8)points and 85.8(85.

关 键 词：肩 撕裂伤 缝合锚 随机对照试验 

分 类 号：R687.4[医药卫生—骨科学]