Promising Phase 1 Results from ACL “Bridge” Repair
Last week, The Boston Globe reported that Martha Murray, MD, an orthopaedist at Boston Children’s Hospital, had announced results from the Phase 1 safety study of “bridge-enhanced” ACL repair, which OrthoBuzz first told you about in April 2015 (see “ACL Self-Repair Moving Toward Reality”). According to the Globe, “all 10 BEAR [Bridge-Enhanced ACL Repair] patients…have new, healthy ACLs regrowing where there were originally tears.”
The Globe article quoted Jo Hannafin, MD, past president of the American Orthopaedic Society for Sports Medicine (AOSSM), as saying that BEAR “has the potential to be a game-changer.” But Dr. Hannifin was quick to add that “these patients will have to be followed for a minimum of two years to determine whether the ACL heals and does that healed ACL stay competent or stretch over time and fail.”
Another key question is how much arthritis will develop in the BEAR knees 15 or 20 years from now. In preclinical studies of BEAR on pigs’ knees, the rates of subsequent knee arthritis were lower than those seen with traditional reconstruction techniques.
The Globe reported that Dr. Murray will start enrolling 100 patients for a Phase 2 randomized trial this summer. She will be seeking people from 14 to 35 years of age with torn ACLs that occur within 30 days of enrollment. Additional inclusion criteria include a tibial ligament stump that is at least 6 to 8 mm in length and no serious concomitant knee damage. Two-thirds of the Phase 2 study enrollees will be randomized to undergo the BEAR procedure, and the other group will undergo traditional ACL reconstruction. Patients will be followed for up to 10 years to assess the competence of the repair and track the development of arthritis.
OrthoBuzz will keep you posted on this important ongoing research.