Bridge-Enhanced ACL Repair-Safety Study (BEAR Trial)
United States20 participantsStarted 2015-01
Plain-language summary
This study will assess the safety and early efficacy of a newly developed device, bridge-enhanced scaffold (MIACH™,) used to repair a torn anterior cruciate ligament (ACL.) Ten participants will undergo surgery with the new device (Experimental Group) and 10 will undergo a standard ACL reconstruction surgery (Control Group.)
Who can participate
Age range
18 Years – 35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Complete ACL tear, confirmed by MRI
* Time from injury to screening must be less than or equal to 90 days
* ACL tissue present on pre-operative MRI
Exclusion Criteria (before surgery):
* Prior surgery on affected knee
* History of prior infection in affected knee
* Regular use of tobacco or nicotine in any form
* Use of corticosteroid within last 6 months
* Ever underwent chemotherapy treatment
* History of sickle cell disease
* History of anaphylaxis
* Any condition that could affect healing (Diabetes, inflammatory arthritis, etc)
* Diagnosis of posterolateral corner injury (LCL complete tear, Biceps femoris tendon avulsion, tear of the arcuate ligament, tear of the popliteus ligament)
* Diagnosis of Grade III medial collateral ligament injury
* Diagnosis of complete patellar dislocation
Exclusion Criteria (during surgery):
* ACL deemed normal on arthroscopic inspection
* Time from injury to surgery is greater than 90 days (for Comparator group) and greater than 30 days (for Experimental group)
* Experimental Group: Less than 50 percent of ACL remaining
* Displaced bucket handle meniscal injury requiring repair
* Diagnosis of full-thickness chondral injury on either condyle
* Grade III medial collateral ligament injury
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.