Status:
ACTIVE_NOT_RECRUITING
A Comparison of ACL Repair With BEAR Device vs. Autograft Patellar Tendon ACL Reconstruction
Lead Sponsor:
The Cleveland Clinic
Collaborating Sponsors:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Miach Orthopaedics
Conditions:
Anterior Cruciate Ligament Tear
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
This study is designed to evaluate bridge-enhanced ACL restoration (BEAR), a new surgical technique for repairing knees injured by a tear of the anterior cruciate ligament (ACL) that promotes reattach...
Detailed Description
The study population will include active and otherwise healthy patients of both genders, all races, and between 18-55 years old at any of six locations, who elect to undergo primary surgery for a torn...
Eligibility Criteria
Inclusion
- 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 (except simple arthroscopy for plica, debris removal, or diagnosis)
- Any prior ACL surgery on unaffected knee (except simple arthroscopy for plica, debris removal, diagnosis or partial meniscectomy)
- 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 III 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)
- Documented history of illicit drug or alcohol abuse (except for recreational use of marijuana)
- 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, requiring a documented medical intervention
- 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
- Not considered by treating physician to be a good research candidate
- 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)
Exclusion
Key Trial Info
Start Date :
August 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2027
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT03776162
Start Date
August 30 2021
End Date
December 1 2027
Last Update
July 29 2025
Active Locations (6)
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1
University of Colorado
Boulder, Colorado, United States, 80309
2
TRIA Orthopaedics Center/ University of Minnesota
Bloomington, Minnesota, United States, 55431
3
Cleveland Clinic
Cleveland, Ohio, United States, 44195
4
Ohio State University
Columbus, Ohio, United States, 43202