Information for current and prospective participants
The BEAR-MOON trial is currently enrolling 200 English-speaking individuals who:
The BEAR-MOON trial is being conducted at six academic hospitals in the United States with a long history of experience in orthopaedic surgery and research:
Eligible BEAR-MOON participants who choose to participate in the trial will receive the same care before and after surgery as they would receive were they not in the trial. In addition they will receive some additional tests just for the study, which include additional muscle strength tests and x-rays during certain visits before and after their surgery. They will also be asked to complete various health assessments while waiting for the doctor. Finally, they will be expected to to follow a physical therapy rehabilitation protocol that is specific to the surgical treatment they receive and to pass certain performance measures before being allowed to return to sports.
Participants will come in for follow-up visits five times in the first year after surgery surgery (2 weeks, 6 weeks, 3 months, and 6 months), which are similar to if they had not participated in the study. Participants will also return for a visit at the research site at 1 and 2 years after surgery (these are considered research visits) and will be able to come back to the research site at any time in-between scheduled visits if there is a need to see the surgeon. There is the potential to be contacted from the research site in the future for additional long-term follow-up outcomes.
Even though interested patients may qualify for consideration in the study, it is necessary to make a final determination that they are eligible for the study once in the operating room. This is done with a diagnostic arthroscopy (examination of the inside of the knee using a special small camera) after participants have been administered anesthesia but before surgical treatment for their ACL tear begins. This exam will look for any other additional injuries in the knee, including severe injury to the cartilage (tissue that lines the knee joint), meniscus (shock absorber in the knee), or other knee ligaments. If any of these findings are present or the surgeon feels other circumstances should preclude participation in the study, the patient will be excluded from the study and will instead receive the current gold standard of ACL treatment (reconstruction with a tendon graft).
Patients who are deemed eligible for the study after the diagnostic arthroscopy will then be randomized with equal probability (like flipping a coin) into one of two surgical groups: the BEAR® group or the standard ACL reconstruction group. Neither the patient nor the research investigator can choose which group will be selected, and patients will not be informed of which treatment they received until two years after surgery. Several of the study team members who will be evaluating participants' knees during the post-operative follow-up period will also not know which surgery was performed.
Surgery costs will be billed to participants' health insurance carriers as would be done if they were not in the study. Pre-authorization will be obtained prior to the surgery by the billing department as usual, but participants whose insurance refuses to preauthorize surgery payment because of study participation will have the option to opt out of the study.
The study BEAR® implant will be provided free of charge to those randomized to that procedure. Both study groups will receive knee braces free of charge that would normally be billed to insurance.
Neither participants nor their insurance will be charged for the costs of any of the testing performed only for the purpose of this research study. These tests include x-rays and extra strength and balance tests that are done for research purposes only. However, participants' insurance will be billed in the standard manner for routine care, and participants will be responsible for costs not covered by their insurance carrier. These costs include any applicable co-payments, coinsurances, and deductibles.