Bridge-enhanced ACL Repair: Mid-term Results of the First-in-human Study

Orthopaedic Journal of Sports Medicine(2017)

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摘要
Objectives:Bridge-enhanced ACL repair (BEAR) is a new technique for treating midsubstance ACL injuries. The technique involves placing a scaffold loaded with the patient’s own blood between the torn ligament ends prior to using suture to realign the ends of the ligament (Fig. 1). Preclinical studies in large animal models found that the mechanical properties of the bridge-enhanced repaired ligaments were similar to reconstructed grafts, and that animals receiving the repair had less osteoarthritis compared to those receiving traditional ACL reconstruction. In this first-in-human study, our goal was to determine if bridge-enhanced ACL repair would be safe in humans and to compare the early outcomes of this new technique with ACL reconstruction in a small cohort of patients.Methods:Nonrandomized controlled trial (Level 2). Both FDA Investigational Device Exemption Approval and IRB approval was obtained prior to starting the study. Twenty patients were enrolled in this study; ten undergoing the bridge-enhanc...
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