Postcommercialisation outcomes of bridge-enhanced anterior cruciate ligament restoration: The first 100 Bridge registry patients.
Academic Article
Overview
abstract
PURPOSE: To review adverse events and outcomes at least 1 year postoperatively from Bridge enhanced ACL restoration (BEAR) in the first 100 subjects of the Bridge registry, a postcommercialisation prospective cohort. METHODS: Consecutive BEAR patients were invited to enroll in the Bridge registry. Technique modifications, adverse events and reoperations were recorded. Physical examinations and patient reported outcomes (International Knee Documentation Committee [IKDC], knee injury and osteoarthritis outcome score [KOOS], Marx and return to sport index [RSI]) were reported at 0, 6, 9 and 12 months. RESULTS: Of the 100 subjects, 94 enrolled postoperatively. Four exited the study. Mean follow up was 15.3 ± 4.7 months. The mean age was 31.3 ± 14.3 years. 67% were female. Classic and modified techniques were each used in 50 cases. The rates of adverse events and reoperations at 1 year were: one deep venous thrombosis, two meniscal injuries without anterior cruciate ligament (ACL) retear and eight reoperations (one debridement, two manipulations, three suture removals, one partial lateral meniscectomy and one medial meniscus repair). Adverse events between 1 and 2 years included one recurrent ACL tear with associated meniscus tears, two meniscal injuries without ACL tear, and one isolated ACL tear. Overall reoperation rate was 8.3% (8/96) at 1 year and 11.5% (11/96) at final follow-up, with 0% ACL retear at 1 year and 2.1% (2/96) ACL retear at final follow-up. Mean IKDC, Marx and RSI scores at 12 months were (N = 79), respectively 82.7 ± 14.6, 7.5 ± 5.36 and 66.6 ± 24.06. Mean KOOS pain, function daily living and function sports and recreational activities were: 92.7 ± 8.6, 96.7 ± 6.0 and 82.0 ± 18.5. Lachman (N = 75) was 0-2 mm in 80.0% (60/75) and 3-5 mm in 20.0% (15/75). Pivot shift (N = 73) was negative in 90.4% (66/73), grade 1 in 8.2% (6/73) and grade 2 in 1.4% (1/73) at 12 months. CONCLUSION: The rates of adverse events of BEAR with and without modification are low at 1 year. Excellent stability and ROM are attained at 1 year. CLINICAL RELEVANCE: BEAR has promising results in postcommercial utilization and is as an alternative to reconstruction. LEVEL OF EVIDENCE: Level II, cohort study.
