We performed the first procedure in the country as part of the BEAR-MOON clinical trial, which is a trial studying a new technology for anterior cruciate ligament (ACL) restoration.
Dr. Marc Tompkins, one of two surgeons on this study, performed the surgery on Lori, a patient who tore her ACL playing soccer. Lori is excited to be a part of this clinical trial, and is hopeful that her participation will help improve outcomes for others who have similar injuries in the future.
After the first procedure, Dr. Tompkins and Dr. Brad Nelson, the principal investigator of the study, shared a few thoughts on the clinical trial and why it’s so exciting for the future of ACL surgery.
What is the BEAR-MOON clinical trial?
Dr. Tompkins: “The BEAR-MOON trial is a multicenter, randomized clinical trial funded by the National Institutes of Health (NIH). The goal is to evaluate the outcomes of the ‘BEAR’ technique for ACL restoration. ‘BEAR’ stands for ‘bridge enhanced ACL restoration,’ which uses a new technology for ACL restoration. Some patients in the study will receive the ‘BEAR’ technique while others will receive a traditional ACL reconstruction with patellar tendon autograft.”
How is this technique different than the current ACL reconstruction?
Dr. Nelson: “ACL reconstruction has proven a successful surgical procedure over the last 40 years. However, this reconstruction method doesn’t restore the knee to its native condition and takes significant time to recover. In contrast, the ACL restoration we are studying has the potential to restore the ligament, overall improving the function of the knee and allowing a faster recovery.”
Dr. Tompkins: “For decades, the standard for ACL surgery has been reconstruction. This surgery typically uses tissue from another area of the patient’s body, such as from the hamstring or quadricep tendons, which becomes the new ACL. This works well, but can cause dysfunction or pain at those sites, and potentially adds more surgical risk at those sites, such as infection. We’re excited about this new technology because it repairs the ACL without using tissue from elsewhere in the patient’s body.”
How did you get involved in this clinical trial?
Dr. Nelson: “TRIA with its affiliation to the University of Minnesota Department of Orthopedic Surgery has been an innovative center since its founding in 2005. We have participated in multiple clinical trials over the years, and using innovative technology to improve patient care is at the core of our mission.”
Dr. Tompkins: “Through my residency program, I’ve been exposed to the ‘BEAR’ research process for many years because of my connection to Martha Murray, the clinician scientist who has brought the ‘BEAR’ procedure into clinical practice. I’ve been fortunate to observe the whole research process as this went from lab testing, to animal studies and now clinical trials. When the NIH approved this multicenter clinical study, TRIA became one of six sites across the country to participate. We are excited to be participating, especially in such a landmark study on this topic.”
How did the first procedure go?
Dr. Tompkins: “It went very well. We had a patient who met all the qualifications and was excited about being part of this clinical trial. Since this study is blinded for the patients and the reviewers, the patient won’t know for two years whether or not they underwent the new ‘BEAR’ procedure.”
How could this study impact patient care in the future?
Dr. Nelson: “Early research on ACL restoration with the BEAR technology has been very encouraging. We are excited to be testing its effectiveness because of the potential to provide more reliable healing of the torn ACL.”
Dr. Tompkins: “If this clinical trial has good results, it will be a game changer for patients. We think this can potentially be a big step forward for ACL procedures, and we’re excited about this chance to study it over the next couple of years.”