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NCT03348995 · ClinicalTrials.gov registry record · NA

The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration

A NA study of Anterior Cruciate Ligament Rupture and Anterior Cruciate Ligament Injury, sponsored by Miach Orthopaedics.

Active
Registry status
NA
Development phase
250
Enrollment target
11
Study locations

NCT03348995 is a NA study of Anterior Cruciate Ligament Rupture and Anterior Cruciate Ligament Injury that is active but no longer recruiting, run by Miach Orthopaedics. The registered enrollment target is 250 participants, above the 120-participant average among 9 other Anterior Cruciate Ligament Rupture trials with a reported enrollment target (108% higher). The trial reports 11 study locations across 11 states.

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The verdict

NCT03348995, a NA study of Anterior Cruciate Ligament Rupture and Anterior Cruciate Ligament Injury, is active but no longer recruiting, sponsored by Miach Orthopaedics.

ACTIVE NOT RECRUITING
Registry status
NA
Development phase
250 participants
Enrollment target
11
Study locations

Study Summary

Bridge-Enhanced ACL Restoration (BEAR) is a new procedure being developed to treat patients with ACL injuries. In the BEAR procedure, an implant is placed between the torn ends of the ACL and the patient's own blood is added to the implant to stimulate ligament healing. We propose the current study to determine if older patients do better than younger patients (or vice versa) with this procedure. This is a cohort study designed to determine if age is a risk factor for a worse outcome after a bridge-enhanced ACL repair (BEAR) as defined by an 11.5 point difference on the IKDC Subjective or Objective Knee Evaluation score at two years after surgery. Additional objectives are to determine the effect of age on safety outcomes including infection, graft rejection, and need for further surgical procedures.

Conditions Studied

Anterior Cruciate Ligament Rupture Anterior Cruciate Ligament Injury

Interventions

  • DEVICE Bridge-Enhanced ACL Restoration (BEAR)

Study Locations (11)

California

  • Scripps Health - San Diego

Florida

  • Florida Orthopedic Institute - Tampa

Georgia

  • Emory University School Of Medicine - Atlanta

Louisiana

  • Ochsner Sports Medicine Institute - New Orleans

Maryland

  • MedStar Health Surgery Center of Timonium - Lutherville

Massachusetts

  • Boston Children's Hospital - Boston

New Jersey

  • Virtua Health - Marlton

Rhode Island

  • Cynthia Chrostek - Providence

Trial Details

FieldValue
Enrollment Target 250 participants
Start Date 2018-04-17
Est. Completion 2034-04-17
Phase NA

Sponsor

Miach Orthopaedics

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03348995

The ClinicalTrials.gov registry entry for NCT03348995 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 250 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 120-participant average among 9 other Anterior Cruciate Ligament Rupture trials with a reported enrollment target (108% higher). The listed sponsor is Miach Orthopaedics, which has 4 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Anterior Cruciate Ligament Rupture appearing as the primary indexed condition, and to 1 intervention - of which Bridge-Enhanced ACL Restoration (BEAR) is the first listed.

NCT03348995 reports 11 study locations spanning 11 distinct geographic areas - top geographies include California, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT03348995 about?

NCT03348995 is a clinical study titled "The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration". Bridge-Enhanced ACL Restoration (BEAR) is a new procedure being developed to treat patients with ACL injuries. In the BEAR procedure, an implant is placed between the torn ends of the ACL and the patient's own blood is added to the implant to stimulate ligament healing. We propose the current study ...

What is the current status of trial NCT03348995?

This trial is currently active not recruiting. It is a NA study. The enrollment target is 250 participants. The study started on 2018-04-17. Estimated completion is 2034-04-17.

What conditions does trial NCT03348995 study?

This clinical trial studies the following conditions: Anterior Cruciate Ligament Rupture, Anterior Cruciate Ligament Injury.

What interventions are being tested in trial NCT03348995?

The interventions under investigation include: Bridge-Enhanced ACL Restoration (BEAR) (DEVICE).

Who is sponsoring clinical trial NCT03348995?

This trial is sponsored by Miach Orthopaedics, which has 4 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03348995 being conducted?

This trial has 11 study locations across California, Florida, Georgia, Louisiana, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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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.