Dr. Edward Chang Leverages Innovative Surgical Approach to Treat First Patient with BEAR® Implant
Falls Church, VA – On October, 2022, Edward Chang, MD, became the first surgeon in Virginia to use the BEAR® Implant to treat an anterior cruciate ligament (ACL) tear during the BEAR III trial. The BEAR Implant is the first medical advancement to enable the body to heal its own torn ACL. This new approach is a paradigm shift from the current standard of care – reconstruction that replaces the ACL with a graft – and is the first innovation in ACL tear treatment in more than 30 years.
The BEAR Implant acts as a bridge to help ends of the torn ACL heal together. The surgeon injects a small amount of the patient’s own blood into the implant and inserts it between the torn ends of the ACL in a minimally invasive procedure. The combination of the BEAR Implant and the patient’s blood enables the body to heal the torn ends of the ACL back together while maintaining the ACL’s original attachments to the femur and tibia. As the ACL heals, the BEAR Implant is resorbed by the body, within approximately eight weeks.
“There are a number of advantages to restoring a ligament instead of replacing it, and the BEAR Implant is an exciting medical technology that is the first to clinically demonstrate that it enables healing of the patient’s torn ACL while maintaining the natural knee anatomy,” said Dr. Chang. “Encouraging clinical studies have shown faster recovery of muscle strength and higher patient satisfaction with regard to readiness to return to sport than traditional ACL reconstruction – the standard of care today.”
Every year, approximately 400,000 ACL injuries occur in the United States. A torn ACL does not heal without treatment, resulting in ACL reconstruction being one of the most common orthopedic procedures in the U.S. Yet the procedure has drawbacks. Some procedures require two separate incisions, and some people who undergo reconstruction are unable to return to the same level of daily activities or sports.
The BEAR Implant has the same potential medical and surgical complications as other orthopedic surgical procedures, including ACL reconstruction. These include the risk of retear, infection, knee pain, meniscus injury and limited range of motion. During a traditional ACL reconstruction, the surgeon completely removes the remaining torn ACL and reconstructs it with either a tendon from the patient’s leg (called an autograft) or a tendon from a deceased donor (called an allograft). As with any surgery, ACL reconstruction has certain risks. About half of people who receive patellar tendon grafts experience pain while kneeling, and those who receive hamstring grafts may have persistent weakness – as much as a 50% deficit two years after surgery.
The BEAR Implant was granted De Novo Approval from the U.S. Food and Drug Administration and is indicated for skeletally mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. Patients must have an ACL stump attached to the tibia to facilitate the restoration. The BEAR Implant must be implanted within 50 days of injury. Patients should discuss their individual symptoms, diagnosis and treatment with their surgeon.
Media Contact: Tracy Connell, tracy.connell@inova.org, 703-289-2087
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About the BEAR III Study
The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration (NCT03348995) is a single-arm, multicenter cohort study enrolling 250 patients, all of whom will receive the BEAR Implant and will be followed for 10 years. BEAR III is or will soon be enrolling patients at orthopedic centers in Florida, Georgia, Louisiana, Maryland, Massachusetts, New Jersey, South Dakota, Texas and Virginia. In the BEAR III clinical study, the BEAR Implant is being evaluated in patients as young as 12 years old with partial or full ACL tears. Use of the BEAR Implant in patients who are under 14 years old, as well as those with partial ACL tears, is considered investigational.
About Inova
Inova is Northern Virginia’s leading nonprofit healthcare provider. Our mission is to provide world-class healthcare – every time, every touch – to each person in every community we have the privilege to serve. Inova’s 20,000 team members provide more than 2 million patient visits each year through an integrated network of hospitals, primary and specialty care practices, emergency and urgent care centers, outpatient services, and destination institutes.
Inova’s five hospitals are consistently recognized by the Centers for Medicare and Medicaid Services, U.S. News & World Report Best Hospitals, and Leapfrog Hospital Safety Grades for excellence in healthcare.
Inova is home to Northern Virginia’s only Level 1 Trauma Center and Level 4 Neonatal Intensive Care Unit. Its hospitals have a total of 1,936 licensed beds. More information about Inova can be found at inova.org.