Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT03776162 · ClinicalTrials.gov registry record · NA

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

A NA study of Anterior Cruciate Ligament Tear, sponsored by The Cleveland Clinic.

Active
Registry status
NA
Development phase
150
Enrollment target
6
Study locations

NCT03776162 is a NA study of Anterior Cruciate Ligament Tear that is active but no longer recruiting, run by The Cleveland Clinic. The registered enrollment target is 150 participants, below the 217-participant average among 11 other Anterior Cruciate Ligament Tear trials with a reported enrollment target (31% lower). The trial reports 6 study locations across 5 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT03776162, a NA study of Anterior Cruciate Ligament Tear, is active but no longer recruiting, sponsored by The Cleveland Clinic.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
150 participants
Enrollment target
6
Study locations

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

Anterior Cruciate Ligament Tear

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

FieldValue
Enrollment Target 150 participants
Start Date 2021-08-30
Est. Completion 2027-12
Phase NA

Sponsor

The Cleveland Clinic

688 total trials

Interested in This Trial?

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, categorized as NA. The registered enrollment target is 150 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 217-participant average among 11 other Anterior Cruciate Ligament Tear trials with a reported enrollment target (31% lower). The listed sponsor is The Cleveland Clinic, which has 688 total studies on file at ClinicalTrials.gov.

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.

NCT03776162 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Ohio, Colorado, Minnesota.

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.

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).

Who is sponsoring clinical trial NCT03776162?

This trial is sponsored by The Cleveland Clinic, which has 688 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Anterior Cruciate Ligament Tear

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Explore more on PlainTrial

Anterior Cruciate Ligament Tear

All registered trials for this condition

Colorado

All trials with a study site in Colorado

Recruiting now

Find trials open to new participants near you

Rankings

Top sponsors, conditions, and phases

Read our methodology - how this data is sourced, computed, and verified.

Related

Browse all → | Rankings →
Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.