Procedure: ACL Reconstruction (Bone Patellar Tendon Bone Graft) Device: Bridge Enhanced ACL Repair (BEAR) Patients will be randomized and will undergo specified rehabilitation protocols post-operatively with primary assessments of knee laxity and patient reported measures at 6 months, 1 year, and 2 years. All patients 18-40 years of age who are candidates for ACL surgery within 50 days of the ACL injury and who present to surgeons participating in the study will be offered participation in the trial.
#Acl surgeons trial
However, no human data yet support that, and this trial will conclude before such a benefit can be observed. Animal studies suggest BEAR may also ameliorate longer-term premature osteoarthritis of the knee, a common consequence of ACL reconstruction surgery. The investigators hypothesize that the ACL repair with BEAR technology will achieve results not appreciably worse than BPTB reconstruction, with a reduced burden of invasive surgery, when assessed over the first two post-operative years. The BEAR technique is investigational and involves surgically placing a sponge (the BEAR scaffold) between the torn ends of the ACL, providing an absorbable scaffold for the ligament ends to grow into. BEAR will be compared to bone to patellar tendon to bone autograft (BPTB) reconstruction, a standard ACL surgical reconstruction technique that replaces a torn portion of the ACL with transplanted patellar tendon tissue, and thus requires additional invasive patellar tendon removal and reuse as a portion of the ACL surgery, in a two group randomized clinical trial (RCT) in which participants will have equal chance of receiving BEAR or BPTB reconstruction. This study is designed to evaluate bridge-enhanced ACL repair (BEAR), a new surgical technique for repairing knees injured by a tear of the anterior cruciate ligament (ACL) that promotes reattachment and healing of the ACL using a blood-enriched implant. Why Should I Register and Submit Results?.
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