Helps Patients Heal Their Torn ACLs in Clinical Study
Virtua is the only health system in N.J. participating in innovative ACL restoration
Virtua Orthopedics & Spine is the only orthopedic practice in New Jersey participating in a post-market clinical trial for the first medical implant to enable the body to heal its own torn anterior cruciate ligament (ACL). Proponents of the Bridge Enhanced ACL Restoration or BEAR® Implant consider it a “paradigm shift” from the current standard of care – as this is the first significant innovation in ACL tear treatment in more than 30 years. Virtua Orthopedics & Spine is one of 10 sites in the U.S. participating in the BEAR III study.
“There are several advantages to restoring a ligament instead of replacing it, and this exciting medical technology is the first to clinically demonstrate that it enables healing of the patient’s torn ACL while maintaining the natural knee anatomy,” said Sean McMillan, DO, sports medicine surgeon at Virtua Orthopedics & Spine, and the first surgeon in New Jersey to perform the surgery.
“Encouraging clinical studies have shown faster recovery of muscle strength and higher patient satisfaction concerning readiness to return to the sport than traditional ACL reconstruction, which makes the BEAR® Implant especially ideal for athletes,” Dr. McMillan continued. “Also, early data has shown the potential for decreased arthritis in the long-term with the BEAR® Implant, which is important for all patients.”
Every year, approximately 400,000 ACL injuries occur in the U.S., making it one of the most common knee injuries. A torn ACL does not have the ability to heal on its own, so ACL tears are often treated with surgery called ACL reconstruction. During this surgery, 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 the tendon of a deceased donor (called an allograft).
Unlike reconstruction, the BEAR® Implant does not require a second surgical site to remove a healthy tendon or use a donor's tendon. Instead, the BEAR® Implant acts as a bridge between the two ends of the torn ACL.
In this minimally invasive procedure, the surgeon injects a small amount of the patient’s blood into the implant and inserts it between the torn ends of the ACL. The combination of the BEAR® Implant and the patient’s blood enables the body to heal the torn ends of the ACL back together. As the ACL heals, the BEAR® Implant is absorbed by the body within approximately eight weeks.
Professional mixed martial arts (MMA) fighter and coach Ryan Cafaro, age 32, was “ecstatic” when he learned he was a candidate for the BEAR® Implant after tearing his ACL in a training session in March 2022. “I extensively researched my options and realized the BEAR® Implant would allow my body to repair my own tissue and give my knee a second life,” he explained. “Standard ACL reconstruction often results in arthritis as you age. I want to continue as an MMA coach after my fighting career is over, and it made sense to me to try and avoid long-term arthritis development.”
Dr. McMillan added, “Every patient is unique, and so it’s exciting to give them more treatment options and access to cutting-edge technology. This allows us to tailor their ACL journey to recovery truly.”
In addition to his position at Virtua, Dr. McMillan is also an assistant professor of orthopedic surgery at Rowan University's School of Osteopathic Medicine. In January 2022, Virtua Health and Rowan University announced an academic affiliation encompassing the School of Medicine and other programs.
The BEAR® Implant was developed by Miach Orthopaedics. It was granted De Novo Approval from the U.S. Food and Drug Administration and is approved for skeletally mature patients at least 14 years of age with a complete rupture of the ACL, as confirmed by MRI. To construct the repair, patients must have an ACL stump attached to the tibia. The BEAR® device must be implanted within 50 days of injury.
The photo images and video below are courtesy of Miach Orthopaedics and provide a thorough overview of ACL restoration utilizing the BEAR® Implant:
About the BEAR III Study
The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration (NCT03348995) is a single-arm, multi-center 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 New Jersey, among eight other states. 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 Virtua Health
Virtua Health is an academic health system committed to helping the people of South Jersey be well, get well, and stay well by providing the complete spectrum of advanced, accessible, and trusted health care services. Virtua’s 14,000 colleagues provide tertiary care, including renowned cardiology and transplant programs, complemented by a community-based care portfolio. In addition to five hospitals, two satellite emergency departments, 30 ambulatory surgery centers, and more than 300 other locations, Virtua brings health services directly into communities through Hospital at Home, physical therapy and rehabilitation, mobile screenings, and its paramedic program. Virtua has 2,850 affiliated doctors and other clinicians, and its specialties include orthopedics, advanced surgery, and maternity. Virtua is academically affiliated with Rowan University, leading research, innovation, and immersive education at the Virtua Health College of Medicine & Health Sciences of Rowan University. Virtua is also affiliated with Penn Medicine for cancer and neuroscience and the Children’s Hospital of Philadelphia for pediatrics. As a not-for-profit, Virtua is committed to the community's well-being and provides innovative outreach programs that address social challenges affecting health, most notably the “Eat Well” food access initiative, which includes the unparalleled Eat Well Mobile Grocery Store. A Magnet-recognized health system ranked by U.S. News and World Report, Virtua has received many awards for quality, safety, and its outstanding work environment. For more information, visit Virtua.org. To help Virtua make a difference, visit GiveToVirtua.org.
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