University Orthopedics 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.
Clinical studies enable medical advances to move knowledge and science forward and often offer the newest treatment approaches. People participate in clinical studies for a variety of reasons. If you have a torn ACL, here are five reasons to consider participating in the BEAR MOON clinical study:
1. Access to two clinically proven treatments Patients in the BEAR MOON clinical study will be randomized to either receive ACL reconstruction with a patellar tendon autograft (BPTB) or ACL restoration with the BEAR® Implant. ACL reconstruction has been the standard of care for ACL surgery for more than 30 years, and the BEAR Implant is a new approach that was approved by the FDA in 2020. Both approaches have published research demonstrating their effectiveness.
2. High-quality care Strict rules for clinical studies have been put into place by the National Institute of Health (NIH) and the FDA. In addition, U.S. clinical studies must be overseen by an Institutional Review Board (IRB) to check that patient risks are as low as possible and that proper study procedures are followed. Patients in clinical studies are monitored closely by their doctor throughout the duration of the study, and information about you will be carefully recorded and reviewed. Participants in the BEAR MOON study are treated by orthopaedic specialists according to a treatment plan called a “protocol” that ensures they stay on track with their recovery.
3. Advancing science Clinical studies offer hope for many people and an opportunity to help researchers find better treatments for others in the future who have their same condition. Your participation in this clinical study, available only at select hospitals in the U.S., may provide long-lasting benefits for others affected by ACL injuries
4. Additional testing free of charge Patients who participate in the BEAR MOON study will receive additional x-rays and strength and balance tests for research purposes. You may find it interesting to have additional insights into your recovery. Be sure to discuss your specific treatment costs with the doctors and nurses conducting the BEAR MOON study before agreeing to participate.
5. Confidentiality Confidentiality is an important part of clinical research – the personal information gathered about you during the clinical study will remain confidential and will not be reported with your name attached. This also means that the personal identity and all medical information of clinical study participants is known only to the individual patient and researchers; results from a clinical study will usually be presented only in terms of trends or overall findings and will not mention specific participants.
Are you eligible for the BEAR MOON clinical study?
To be eligible for the clinical study, you must be between the ages of 18 and 55, have an ACL tear within 50 days of the expected surgery date and have a BMI less than 45 kg/m2. To learn more, please email BEAR.TRIAL@LIFESPAN.ORG or call 1-401-649-1906. or visit the University Orthopedics BEAR-MOON Trial page.
Dr. Brett Owens, a surgeon at UOI and principal investigator of the ongoing trial, spoke with Channel 12 reporter Alexandra Leslie about the groundbreaking procedure.
Every year, approximately 400,000 anterior cruciate ligament (ACL) injuries occur. ACL reconstruction surgery is one of the most common orthopedic procedures in the United States. Unlike other ligaments, the ends of a torn ACL do not reconnect naturally. During an ACL reconstruction, an orthopedic surgeon removes the ends of the torn ACL and replaces them with a graft, usually taken from either the patient’s patellar or the hamstring tendon. Although most patients can return to sports, the ACL re-tear rate can be as high as 20 percent for teens. Up to 80 percent of patients develop arthritis 15 to 20 years after surgery.
The bridge-enhanced ACL restoration (BEAR®), uses stitches and a bridging scaffold (a sponge injected with the patient’s blood) to stimulate healing of the torn ACL. The procedure has been performed in preclinical models and over 100 patients with excellent results. The goal of the current study is to determine if this new technique, which repairs the torn ACL is comparable to the patellar tendon ACL reconstruction surgery.
Dr. Paul Fadale, Dr. Michael Hulstyn, and Dr. Owens –, all University Orthopedics surgeons – are the only providers in the region performing the procedure.
Individuals who have recently suffered an ACL injury and are between the ages of 18 and 55 may be candidates to participate in the BEAR-MOON trial. To learn more about the BEARMOON trial or schedule an appointment with a BEAR-MOON trial physician, please email BEAR.TRIAL@LIFESPAN.ORG or call 1-401-649-1906. You can also learn more about this clinical trial and the BEAR ACL restoration procedure at www.bearmoon.org.