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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

This is a survey patients complete about how their knee is feeling and functioning. Range is 0 to 100, with 100 indicating no problems and 0 indicating extreme problems.

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
Miach Orthopaedics

4 total trials

What the registry record for NCT03348995 still lists

NCT03348995 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, above the 120-participant average among 9 other Anterior Cruciate Ligament Rupture trials with a reported enrollment target (108% higher).

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 lists 11 locations in 11 states (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.

Learn More About Clinical Trials

Similar trials for Anterior Cruciate Ligament Rupture

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.

Where NCT03348995's enrollment target sits among peer trials

250 2nd of 9 the highest of 9 other Anterior Cruciate Ligament Rupture trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Anterior Cruciate Ligament Rupture trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03348995, the US trial registry maintained by the National Library of Medicine. NCT03348995 (mid enrollment · multi site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.