Fleming Braden C, Baranker Ben, Badger Gary J, Kiapour Ata M, Ecklund Kirsten, Micheli Lyle J, Murray Martha M
Department of Orthopaedics, Brown University, Rhode Island Hospital, Providence, Rhode Island, USA.
Department of Orthopaedic Surgery, Boston Children's Hospital, Boston, Massachusetts, USA.
Orthop J Sports Med. 2024 Aug 13;12(8):23259671241260632. doi: 10.1177/23259671241260632. eCollection 2024 Aug.
Bridge-enhanced anterior cruciate ligament restoration (BEAR) combines suture repair of the anterior cruciate ligament (ACL) with an extracellular matrix implant plus autologous blood to facilitate native ACL healing.
PURPOSE/HYPOTHESIS: The purpose of this study was to compare the 6-year follow-up outcomes of patients who underwent the BEAR procedure with those of a nonrandomized concurrent control group receiving autograft ACL reconstruction (ACLR) in the first-in-human safety study of the BEAR implant (BEAR I trial). Based on the 2-year results, it was hypothesized that isometric hamstring strength after the BEAR procedure would be greater than that after ACLR and that there would be no other differences in outcomes at 6 years.
Cohort study, Level of evidence, 2.
Ten patients underwent BEAR and 10 received ACLR with a 4-stranded hamstring autograft. Outcomes assessed included the record of subsequent surgeries, the International Knee Documentation Committee (IKDC) Subjective Knee Score, IKDC physical examination grade, the Knee injury and Osteoarthritis Outcome Score, instrumented knee laxity, functional outcomes (ie, muscle strength assessments and hop testing), and qualitative magnetic resonance imaging assessment. Comparisons between treatments were based on computations of the mean differences and the associated 95% CIs.
One patient in the BEAR group and 3 patients in the ACLR group were lost to follow-up. In the period between 2 and 6 years, 1 patient in each group underwent revision surgery. There were no differences between groups at the 6-year follow-up in any of the outcome measures except for isometric hamstring strength, which was approximately equal to that of the contralateral knee in the BEAR group and <44% of that in the contralateral knee in the ACLR group ( < .01).
This preliminary study suggests that the outcomes of BEAR and ACLR with a hamstring tendon graft may be similar at the 6-year follow-up and warrants investigation of the BEAR procedure in a larger cohort of patients.
桥接增强前交叉韧带修复术（BEAR）将前交叉韧带（ACL）的缝线修复与细胞外基质植入物加自体血相结合，以促进天然ACL愈合。
目的/假设：本研究的目的是在BEAR植入物的首次人体安全性研究（BEAR I试验）中，比较接受BEAR手术的患者与接受自体移植ACL重建术（ACLR）的非随机同期对照组患者的6年随访结果。基于2年的结果，假设BEAR手术后等长腘绳肌力量将大于ACLR术后，并且在6年时结果无其他差异。
队列研究，证据级别为2级。
10例患者接受BEAR手术，10例接受4股腘绳肌自体移植的ACLR手术。评估的结果包括后续手术记录、国际膝关节文献委员会（IKDC）主观膝关节评分、IKDC体格检查分级、膝关节损伤和骨关节炎转归评分、仪器测量的膝关节松弛度、功能结果（即肌肉力量评估和单腿跳测试）以及定性磁共振成像评估。治疗组之间的比较基于平均差异和相关95%置信区间的计算。
BEAR组有1例患者和ACLR组有3例患者失访。在2至6年期间，每组各有1例患者接受了翻修手术。除等长腘绳肌力量外，两组在6年随访时的任何结果指标上均无差异，BEAR组的等长腘绳肌力量约等于对侧膝关节，而ACLR组的等长腘绳肌力量小于对侧膝关节的44%（P <.01）。
这项初步研究表明，在6年随访时，BEAR手术和腘绳肌腱移植ACLR手术的结果可能相似，值得在更大规模的患者队列中对BEAR手术进行研究。
