PROVIDENCE, R.I. (WPRI) — A new approach to treating a common but potentially devastating injury is being tested right here in Rhode Island.
Lifespan Orthopedics Institute is helping test a new way to treat a ruptured anterior cruciate ligament (ACL) using a biological implant.
Lifespan is one of six clinical trial sites in the country, and the only one in New England, to see if a less invasive procedure using what’s called a Bridge-Enhanced ACL Restoration (BEAR) Implant is more beneficial than traditional ACL surgery.
The implant is what doctors describe as a “collagen sponge” that gets populated with the patient’s own blood in an effort to bridge the ACL “back to its native footprint.”
Doctors say the standard reconstructive surgery comes with a lot of challenges, including up to a year of recovery time and the risk of developing osteoarthritis.
ACL injuries affect around 400,000 Americans a year. Dr. Brett Owens, a surgeon with the Lifespan Orthopedics Institute and principal investigator for the local BEAR Implant trial, said he’s seen them occur in people of all ages, with various activity levels, but noted they’re especially common in young athletes.
“Unfortunately, we can see recurrent injuries, especially when high-activity athletes get back to their previous level of activity. We can see re-tears,” Owens explained.
Owens says in his 20 years performing ACL reconstruction surgeries, little has changed with the technique behind the procedure.
“This is a very different approach where we try to preserve the native ligament that’s torn, and then we’re able to shuttle sutures across it and then bridge that gap with with the implant, and then perform a restoration of the patient’s native ACL,” Owens explained.
Doctors say the implant allows the tendon inside the knee to heal itself and avoids the need for a graft from somewhere else on the patient, a painful part of a typical ACL reconstruction surgery.
“You’re not just recovering from the reconstruction, you’re also recovering from the harvest of the graft, and that’s one thing that the BEAR procedure touts as an advantage,” Owens noted.
That’s part of the reason researchers wanted to find out why the ACL doesn’t heal on its own, according to Owens.
The research started with Dr. Martha Murray at Boston Children’s Hospital in the late 1990s, before a collaboration with Rhode Island Hospital and Brown University for preclinical studies, which involved testing cartilage from pigs.
“She came to us to begin some of the preclinical studies where we actually wanted to optimize the scaffold and compare it to standard of care, which is ACL reconstruction. So, several preclinical studies would have been to try to do that,” said Dr. Braden Fleming, an orthopedics researcher with Lifespan and Brown University.
“These studies were important not only for the development of the device itself or recruitment of the device, but to provide all the data that was necessary to get FDA approval to move the scaffolds into human use,” Fleming added.
Human studies then began testing the BEAR implant against the standard of care.
“It looked like the ACL-restored knees were at least equivalent to reconstructed knees,” Fleming said.
Fleming said it’s still too early to tell what some of the long-term benefits will be, but researchers are hopeful based on the results of the preclinical studies of cartilage.
“The outcome, it looks very promising,” he added.
After promising results utilizing the procedure in the BEAR I and BEAR II trials, two additional studies — BEAR III trial and BEAR-MOON (Multicenter Orthopaedic Outcomes Network) — were approved by the U.S. Food & Drug Administration (FDA).
The BEAR-MOON research study was approved by the FDA and is funded by grants from the National Institutes of Health and the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Recruitment for the trial was initiated last September, and the study is currently underway.
The BEAR-MOON trial is enrolling 200 English-speaking individuals nationwide who:
- Are between the ages of 18 and 55
- Have suffered a complete ACL tear (as documented on an MRI scan by a medical professional) within the past 50 days
- Were advised by a medical professional that surgery is recommended to treat the ACL tear
- Are willing to follow the study instructions for return visits and rehabilitation exercises