A Comparison of ACL Repair With BEAR Device vs. Autograft Patellar Tendon ACL Reconstruction (BEAR-MOON)
Anterior Cruciate Ligament Tear
About this trial
This is an interventional treatment trial for Anterior Cruciate Ligament Tear focused on measuring Anterior Cruciate Ligament Tear, Anterior Cruciate Ligament Reconstruction, Anterior Cruciate Ligament Repair, Knee Surgery
Eligibility Criteria
INCLUSION CRITERIA
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- 18-55 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 ACL surgery on affected knee (simple arthroscopy for plica, debris removal, or diagnosis is accepted)
- Any prior ACL surgery on unaffected knee (simple arthroscopy for plica, debris removal, diagnosis or partial meniscectomy is accepted)
- 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 ≥45
- Does not speak or understand English
- Daily smoking (occasional or social use is accepted if smoking ≤ 3 days/ week and ≤ 5 cigarettes/day)
- 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 corticosteroids for treatment of an autoimmune disorder such as lupus, rheumatoid arthritis, etc. (maintenance or rescue inhaler for asthma is allowed)
- 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)
Sites / Locations
- University of ColoradoRecruiting
- TRIA Orthopaedics Center/ University of MinnesotaRecruiting
- Cleveland ClinicRecruiting
- Ohio State UniversityRecruiting
- University Orthopedics Institute/ Rhode Island HospitalRecruiting
- Vanderbilt UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
ACL Reconstruction(BPTB Graft)
Bridge Enhanced ACL Restoration
Procedure/Surgery ACL Reconstruction (Bone Patellar Tendon Bone Graft): Standard of care surgical procedure Patellar Tendon Autograft ACL reconstruction, in which a bone-patellar tendon-bone graft from the front of the knee is taken to replace the torn ACL.
Procedure/Surgery Bridge Enhanced ACL Restoration (BEAR): The surgical repair of the ACL using the BEAR technique involves surgically placing a sponge (the BEAR implant) between the torn ends of the ACL, providing a sponge for the ligament ends to group into.