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

Running, not enrolling · Not applicable

Conditions studied: Anterior Cruciate Ligament Tear

In brief

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 reattachment and healing of the ACL using a blood-enriched implant. BEAR will be compared to bone to patellar tendon to bone autograft (BPTB) reconstruction, a standard ACL surgical reconstruction technique that replaces a torn portion of the ACL with transplanted patellar tendon tissue, and thus requires additional invasive patellar tendon removal and reuse as a portion of the ACL surgery, in a two group randomized clinical trial (RCT) in which participants will have equal chance of receiving BEAR or BPTB reconstruction. The BEAR technique is FDA approved and involves surgically placing a sponge (the BEAR implant) between the torn ends of the ACL, providing an absorbable implant for the ligament ends to grow into. The investigators hypothesize that the ACL repair with BEAR technology will achieve results not appreciably worse than BPTB reconstruction, with a reduced burden of invasive surgery, when assessed over the first two post-operative years. Animal studies suggest BEAR may also ameliorate longer-term premature osteoarthritis of the knee, a common consequence of ACL reconstruction surgery. However, no human data yet support that, and this trial will conclude before such a benefit can be observed. All patients 18-55 years of age who are candidates for ACL surgery within 50 days of the ACL injury and who present to surgeons participating in the study will be offered participation in the trial. Patients will be randomized and will undergo specified rehabilitation protocols post-operatively with primary assessments of knee laxity and patient reported measures at 6 months, 1 year, and 2 years.

Key facts

Study ID

NCT03776162

Run by

The Cleveland Clinic

People needed

150

Starts

2021-08-30

Expected to finish

2027-12-01

Last updated by the study team

2025-07-29

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

Where it is running

• University of Colorado — Boulder, Colorado, United States
• TRIA Orthopaedics Center/ University of Minnesota — Bloomington, Minnesota, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Ohio State University — Columbus, Ohio, United States
• University Orthopedics Institute/ Rhode Island Hospital — Providence, Rhode Island, United States
• Vanderbilt University — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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