先进韧带增强装置用于初次前交叉韧带重建术后不良事件的临床多中心调查分析

Clinical multicenter investigation and analysis of the adverse events after primary anterior cruciate ligament reconstruction using the ligament advanced reinforcement system

目的调查先进韧带增强装置(LARS)进行初次前交叉韧带重建(ACLR)的术后不良事件发生情况,为规范人工韧带临床应用寻找依据。方法建立中国人工韧带研究小组,按照纳入标准和排除标准,对2004年7月1日至2010年12月31日期间在我国20家骨科运动医学中心采用LARS进行ACLR(LARS-ACLR)的病例进行随访。通过随访研究和病例筛查,确认不良事件发生率,包括累积失败率和并发症发生率。累积失败包括移植物断裂和临床失败两种情况,其中移植物断裂经关节镜确认,临床失败需满足以下任一条件:(1)膝关节活动度受限(膝关节伸直受限>5°、屈曲受限>15°,与健侧对照);(2)关节松弛(Lachman试验≥Ⅱ级、pivot shift试验≥Ⅱ级、胫骨前移量双侧差>5 mm)。收集累积失败病例人口统计学信息及一般临床资料,统计分析累积失败率、并发症率、累积失败病例中不同程度关节症状的构成比、失败原因的构成比。结果共完成1705例LARS-ACLR,1393例满足标准纳入研究,其中247例失访,1146例完成随访,随访率为83.3%,随访时间M(Q_(1),Q_(3))为87.1(68.2,116.0)个月。98例患者确认发生不良事件,包括累积失败51例和并发症47例,累积失败率为4.5%(51/1146),并发症发生率为4.1%(47/1146)。累积失败时间M(Q1,Q3)为12(7,24)个月,其中44例患者出现关节不稳(86.3%,44/51);39例患者出现关节疼痛(76.5%,39/51);31例患者出现关节肿胀(60.8%,31/51);25例患者出现关节别卡感或交锁(49.0%,25/51);10例患者屈曲受限>15°(19.6%,10/51);1例患者伸直受限>10°(2.0%,1/51)。累积失败的51例患者中,32例存在明确的骨隧道定位错误(62.7%,32/51);25例患者由于再次外伤断裂(49.0%,25/51);21例患者镜下确认移植物断裂(41.2%,21/51);8例患者为螺钉松动(15.7%,8/51)。47例患者出现并发症,其中螺钉相关问题20例(1.7%,20/1146);轻度滑膜炎18例(1.6%,18/1146);关节粘连6例(0.5%,6/1146);感染3例(0.3%,3/1146)。结论LARS-ACLR术后远期的累积失败率为4.5%,并发症发生率为4.1%。关节不稳和疼痛是LARS-ACLR累积失败病例的主要关节症状;骨隧道定位错误是人工韧带失败的首要原因,应引起临床医生的高度关注。

Objective To investigate the postoperative adverse events after primary anterior cruciate ligament reconstruction(ACLR)using the ligament advanced reinforcement system(LARS)for establishing grounds to standardize the clinical use of artificial ligaments.Methods The China Artificial Ligament Study Group(CALSG)was organized to follow up the cases of ACLR using the LARS(LARS-ACLR)at 20 orthopedic sports medicine centers in China between July 1,2004 and December 31,2010.Adverse events,including cumulative failures and complications,were identified through follow-up study and case screening.The cumulative failure was classified as graft rupture and clinical failure,with graft rupture confirmed by arthroscopy and clinical failure confirmed by either limited knee range of motion(>5°in extension and/or>15°in flexion,contralateral knee as control)or joint laxity(Lachman test≥Ⅱ,pivot shift test≥Ⅱ,side-to-side difference>5 mm).The demographic information and clinical data of cumulative failure cases were collected,and the cumulative failure rate,the complication rate,the composition ratio of different degrees of joint symptoms among cumulative failure cases,and the composition ratio of failure causes were statistically analyzed.Results A total of 1705 cases of LARS-ACLR were collected at 20 centers,of which 1393 met the inclusion criteria of the study.Of the included cases,1146 completed the follow-up,with a follow-up rate of 83.3%(1146/1393)and a median follow-up time[M(Q_(1),Q_(3))]of 87.1(68.2,116.0)months.Ninety-eight adverse events were identified,including 51 cumulative failures and 47 complications,with a cumulative failure rate of 4.5%(51/1146)and a complication rate of 4.1%(47/1146).The median cumulative failure time[M(Q_(1),Q_(3))]was 12(7,24)months after surgery,with 44 patients(86.3%,44/51)presenting with joint instability,39 patients(76.5%,39/51)with joint pain,31 patients(60.8%,31/51)with joint swelling,25 patients(49.0%,25/51)feeling knee catching and locking,10 patients with flexion restriction greater than 15°(19.6%,10/51),and 1 patients with extension restriction greater than 10°(2.0%,1/51).The incorrect bone tunnel position were confirmed in 32 patients(62.7%,32/51)and reinjury in 25 patients(49.0%,25/51).The graft rupture was confirmed under arthroscopy in 21 patients(41.2%,21/51)and screw loosening occurred in 8 patients(15.7%,8/51).Complications were detected in 47 patients,with screw-related problems confirmed in 20 patients(1.7%,20/1146),synovitis in 18 patients(1.6%,18/1146),stiffness in 6 patients(0.5%,6/1146),and infection in 3 patients(0.3%,3/1146).Conclusions The long-term cumulative failure rate is 4.5%and the complication rate is 4.1%after LARS-ACLR.Joint instability and pain are the main joint symptoms in cumulative failure cases of LARS-ACLR.Incorrect bone tunnel positioning is the primary cause of failure and should be of great concern to clinicians.