100例桥增强前交叉韧带修复上市后队列两年随访显示低再撕裂率和良好患者报告结局
简介
商业化后BEAR（桥接增强ACL修复）注册前瞻队列前100例2年随访显示，同侧ACL再撕裂率5.6%，总再手术率18.9%；改良技术再手术率低于原技术（7.5% vs 28.0%），但两组再撕裂率无差异。术后1年稳定性与关节活动度良好，2年IKDC及部分KOOS改善，提示BEAR再撕裂率低、患者报告结果良好。
英文摘要
PURPOSE: To review adverse events and outcomes 2 years postoperatively from the Bridge Enhanced anterior cruciate ligament (ACL) Restoration (BEAR) procedure in the first 100 subjects of the Bridge registry, a postcommercialisation prospective cohort. METHODS: Technique modifications (repair and bridging suture type, femoral and tibial fixation), adverse events and reoperations were recorded. Physical examinations were reported at 0, 6, 9 and 12 months and patient-reported outcomes (International Knee Documentation Committee, knee injury and osteoarthritis outcome score, Marx, return to sport index) were reported at 0, 6, 9, 12 and 24 months. Adverse events were compared between the original and modified technique groups using Fisher's Exact test. Paired t-tests were used to compare patient-reported outcomes at 1 and 2 years. RESULTS: Mean follow-up was 22.3 ± 5.5 months, range 3-32.7 months, with five subjects exiting early. Mean age was 31.8 ± 14.3 years (range 7.7-69.6). Sixty-seven per cent were female. Fifty-five underwent a BEAR procedure using the original technique, while 45 had a modified surgical technique. The overall rates of adverse events with reoperations at 2 years included: two ACL retears with meniscus injury, two ACL retears without meniscus injury, two contralateral tears, five meniscus injuries without ACL retear (one medial, three lateral, one both medial and lateral), two manipulations under anaesthesia, one lysis of adhesions/cyclops removal and four removals of retained suture. Overall reoperation rate was 18.9% (17/90) at 2 years (28.0% with original technique, 7.5% with modified technique; p = 0.02) with 5.6% (5/90) ipsilateral ACL retear rate. There were no significant differences in ACL retear rates between the original technique and modified technique groups. From 1 to 2 years, there were statistically significant improvements in IKDC and three of the five KOOS scales. CONCLUSION: The rates of ACL retear status post BEAR with and without modification are low at 2 years, with five retears occurring between 14 and 28 months. Excellent stability and range of motion are attained at 1 year, with good patient reported outcomes measures at 2 years. LEVEL OF EVIDENCE: Level II, cohort study.