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A Comparison of ACL Repair With BEAR Device vs. Autograft Patellar Tendon ACL Reconstruction
NCT03776162 · View on ClinicalTrials.gov ↗
Study 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 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.
Conditions Studied
Interventions
- PROCEDURE ACL Reconstruction (Bone Patellar Tendon Bone Graft)
- DEVICE Bridge Enhanced ACL Restoration (BEAR)
Study Locations (6)
Ohio
- Cleveland Clinic — Cleveland
- Ohio State University — Columbus
Colorado
- University of Colorado — Boulder
Minnesota
- TRIA Orthopaedics Center/ University of Minnesota — Bloomington
Rhode Island
- University Orthopedics Institute/ Rhode Island Hospital — Providence
Tennessee
- Vanderbilt University — Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 150 participants |
| Start Date | 2021-08-30 |
| Est. Completion | 2027-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03776162
The ClinicalTrials.gov registry entry for NCT03776162 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is The Cleveland Clinic, which has 607 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Anterior Cruciate Ligament Tear appearing as the primary indexed condition, and to 2 interventions — of which ACL Reconstruction (Bone Patellar Tendon Bone Graft) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03776162 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Ohio, Colorado, Minnesota. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03776162 about?
NCT03776162 is a clinical study titled "A Comparison of ACL Repair With BEAR Device vs. Autograft Patellar Tendon ACL Reconstruction". 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 patella...
What is the current status of trial NCT03776162?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 150 participants. The study started on 2021-08-30. Estimated completion is 2027-12.
What conditions does trial NCT03776162 study?
This clinical trial studies the following conditions: Anterior Cruciate Ligament Tear. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03776162?
The interventions under investigation include: ACL Reconstruction (Bone Patellar Tendon Bone Graft) (PROCEDURE), Bridge Enhanced ACL Restoration (BEAR) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03776162?
This trial is sponsored by The Cleveland Clinic, which has 607 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03776162 being conducted?
This trial has 6 study locations across Colorado, Minnesota, Ohio, Rhode Island, Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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