Nicklaus Children’s Hospital is the first children’s hospital in South Florida to offer the BEAR® Implant for treatment of anterior cruciate ligament (ACL) tears, one of the most common knee injuries in the U.S. 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. Since March 2023, the hospital has performed four BEAR implant procedures on patients ranging in age from 14 to 17.
Every year, approximately 400,000 ACL injuries occur in the U.S. The population group most affected by these injuries is adolescent females ages 15 to 20, followed by males in the same age range. 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.
“At Nicklaus Children’s Orthopedic, Sports Medicine and Spine Institute, we are committed to offering the latest treatments to ensure that our patients can receive the best clinical approach to meet their individual needs,” said Dr. Craig Spurdle, the program’s medical director. “For eligible patients, 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. Early 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. Our commitment to offering the latest surgical techniques to our patients is one more example of why Nicklaus Children’s is the hospital where children matter most.”
Clinicians performing the procedure at Nicklaus Children’s include Dr. Roger Saldana, Dr. Spurdle and Dr. Margaret Wright, all specialists in orthopedics and sports medicine.
During an ACL reconstruction, the surgeon completely removes the remaining torn ACL and reconstructs it with either a tendon from the patient’s own leg (called an autograft) or 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 can have persistent weakness even two years after surgery.
Unlike reconstruction, the BEAR Implant does not require a second surgical wound site to remove a healthy tendon from another part of the leg or the use of a donor tendon. 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. To be eligible for the treatment, one centimeter of the patient’s torn ACL must still be attached to the tibia.
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. Patients should discuss their individual symptoms, diagnosis and treatment with their surgeon. The BEAR Implant has the same potential medical/surgical complications as other orthopedic surgical procedures, including ACL reconstruction. These include the risk of re-tear, infection, knee pain, meniscus injury and limited range of motion.