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 (MIACHâ„¢,) 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 range18 Years – 35 Years
SexALL
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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