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A Comparison of ACL Repair With BEAR Device vs. Autograft Patellar Tendon ACL Reconstruction

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This study is designed to determine whether anterior cruciate ligament (ACL) repair with the bridge-enhanced ACL repair (BEAR) device is inferior to autograft patellar tendon ACL reconstruction. We hypothesize that the ACL repair with BEAR technology (which does not require harvest of autograft tissue like patellar tendon) will not be inferior to patellar tendon ACL reconstruction in either of the co-primary outcomes. Our co-primary endpoints will be assessed by blinded assessors and include instrumented anterior laxity (KT-1000) and a patient reported outcome measure (IKDC Subjective Score). All patients 18-40 years of age presenting to surgeons in the study who are candidates for ACL surgery (scheduled within 50 days of injury) will be offered participation in the randomized control trial (RCT). Patients will be randomized and will undergo specified rehabilitation protocols post-operatively with primary assessments of KT1000 and IKDC Subjective Score at 6 months, 1 year, and 2 years.

I'm interested

All
18 Years to 40 Years old
This study is NOT accepting healthy volunteers
INCLUSION CRITERIA In order to be eligible to participate in this study, an individual must meet all of the following criteria:
• 18-40 years of age
• Complete ACL tear as confirmed by MRI
• Selected surgical treatment of ACL injury
• Believed to be a surgical candidate for ACL reconstruction by treating physician
• Time from injury to surgery is ≤50 days
• Stated willingness to comply with all study procedures for the duration of the study, including lifestyle, activity, and sports restrictions
• Provision of signed and dated informed consent form EXCLUSION CRITERIA AT PRE-OPERATIVE EXAM An individual who meets any of the following criteria, either during a pre-operative exam or during intraoperative arthroscopic evaluation, will be excluded from participation in this study:
• Any prior surgery on affected or unaffected knee
• Confirmed or suspected contralateral ACL tear
• ACL tear found to be only partial and the treating physician feels it does not require surgery because it is "stable"
• Diagnosis of posterolateral corner injury (complete lateral collateral ligament tear, biceps femoris tendon avulsion, arcuate ligament tear, popliteus ligament tear) that requires concurrent or staged surgical treatment
• Diagnosis of Grade 3 medial collateral injury that requires concurrent or staged surgery
• Insufficient ACL tissue on MRI
• Diagnosis of complete patellar dislocation
• Diagnosis of complete patellar tendon or quadriceps tear
• Obesity with a BMI ≥35
• Does not speak or understand English
• History of regular tobacco or nicotine use in any form
• History of drug or alcohol abuse
• Inability to take oral medications
• Use of intra-articular corticosteroids in the affected knee within last 6 months
• Chronic use of oral corticosteroids (e.g., to treat lupus, rheumatoid arthritis, asthma, etc.)
• History of prior infection in knee
• History of chemotherapy treatment
• History of sickle cell disease
• History of anaphylaxis
• Any condition that, in the opinion of the investigator, could affect healing (e.g., diabetes, inflammatory arthritis, etc.)
• Pregnancy or lactation
• Known allergic reactions to meat products or collagen
• Known allergy to bovine collagen, bovine gelatin, or other bovine products
• Known adverse reaction to any bovine product
• Febrile illness within 7 days
• Treatment with another investigational drug or other intervention, either concurrently or previously, that would interfere with surgical healing EXCLUSION CRITERIA AT INTRAOPERATIVE ARTHROSCOPIC EVALUATION
• Time from injury to surgery has exceeded 50 days
• No ACL tear found upon arthroscopic inspection
• ACL tear found to be only partial, with normal pivot shift and endpoint, and does not require surgery
• Displaced bucket handle meniscal injury requiring repair
• Diagnosis of full-thickness chondral injury of Grade 3 or 4, or that requires more than microfracture (i.e., osteochondral autograft transplant), on either condyle
• Unrecognized lateral or medial sided Grade 3 ligamentous injury that requires concurrent or staged surgery
• Tibial stump length is < 1cm
• Tibial footprint attachment is < 50% intact
• Any other reason the ACL stump should be deemed irreparable (e.g., tissue quality too poor to hold suture)

Procedure: ACL Reconstruction (Bone Patellar Tendon Bone Graft), Device: Bridge Enhanced ACL Repair (BEAR)

Anterior Cruciate Ligament Tear

Anterior Cruciate Ligament Tear, Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Repair, Knee Surgery

sfinder@umn.edu
N/A
NCT03776162
See this study on ClinicalTrials.gov

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