Miach Ortho Begins BEAR Implant Registry Study

Miach Orthopaedics has begun the Bridge Registry Post-Market Study for its Bridge-Enhanced ACL Restoration (BEAR) implant for anterior cruciate ligament (ACL) tears.
 
The registry will analyze BEAR implant real-world evidence, with approval to enroll up to 750 patients at us to 30 U.S. sites. Primary outcomes being tracked are knee function and feeling, measured by International Knee Documentation Committee (IKDC) Subjective Knee Evaluation at two years and knee laxity measured with Lachman scoring at one year.
 
“Our orthopedic sports medicine team at Rothman Orthopaedics Florida and AdventHealth are thrilled to offer our adult and pediatric patients the most innovative technologies to optimize patient recovery and performance after ACL injury,” Dr. Daryl C. Osbahr, chief of orthopedic surgery at AdventHealth’s Rothman Orthopaedic Institute and co-lead principal investigator for the study, told the press. “The BEAR procedure and Bridge Registry enable our team to provide cutting edge techniques to our patients while also being focused on conducting research with the goal of continually refining our techniques based on evidence-based outcomes.”
 
The BEAR implant acts as a bridge to restore the patient’s own ACL. It’s a shift from the current standard of care—reconstruction that replaces the ACL with a graft. The BEAR implant helps the torn ends of the ACL health together, holding and protecting the patient’s own blood in the gap between the ACL ends to allow clot formation.
 
“As we are now just over a year since our very first BEAR procedure, we continue to be impressed with the results,” said Dr. Sabrina Strickland, orthopedic surgeon at Hospital for Special Surgery and co-lead principal investigator for the study. “I look forward to being a part of the Bridge Registry, as careful follow-up of the outcomes of surgery allows us to accurately assess surgical techniques.”
 
Academic institutions currently recruiting patients include AdventHealth (Florida), Duke University (North Carolina), and Hospital for Special Surgery (New York).
 
Institutions enrolling patients soon include Boston Children’s Hospital, Ochsner Health System (Louisiana) Stanford University School of Medicine, Steamboat Orthopaedic & Spine Institute (Colorado), Victory Sports Medicine/Auburn Community Hospital (New York), and Virtua Health (New Jersey).
 
“The Bridge Registry provides evidence to supplement the extensive base of clinical trial research that has been conducted on the BEAR Implant over the last few decades,” said Patrick McBrayer, president and CEO, Miach Orthopaedics. “The real-world evidence we collect through the registry will enable us to track key outcomes as the BEAR procedure is adapted for commercial use.”