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Active, not recruiting Not applicable Interventional

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

ClinicalTrials.gov ID: NCT03348995

Public ClinicalTrials.gov record NCT03348995. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 10:23 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Prospective Cohort Clinical Trial Evaluating Age as a Risk Factor for Poor Outcomes of Bridge-Enhanced ACL Restoration (BEAR)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT03348995
Recruitment status
Active, not recruiting
Study type
Interventional
Phase
Not applicable
Lead sponsor
Miach Orthopaedics
Industry
Enrollment
250 participants

Conditions and interventions

Eligibility (public fields only)

Age range
12 Years to 80 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Apr 17, 2018 (Actual)
Primary completion
Feb 28, 2026 (Actual)
Completion
Apr 17, 2034 (Estimated)
Last update posted
Jun 9, 2026

2018 – 2034

United States locations

U.S. sites
11
U.S. states
11
U.S. cities
11
Facility City State ZIP Site status
Scripps Health San Diego California 92121 —
Florida Orthopedic Institute Tampa Florida 33637 —
Emory University School Of Medicine Atlanta Georgia 30329 —
Ochsner Sports Medicine Institute New Orleans Louisiana 70121 —
MedStar Health Surgery Center of Timonium Lutherville Maryland 21093 —
Boston Children's Hospital Boston Massachusetts 02115 —
Virtua Health Marlton New Jersey 08053 —
Cynthia Chrostek Providence Rhode Island 02903 —
Orthopedic Institute of Sioux Falls Sioux Falls South Dakota 57105 —
UT Southwestern Dallas Texas 75390 —
Inova Sports Medicine Fairfax Virginia 22031 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT03348995, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Jun 9, 2026 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT03348995 live on ClinicalTrials.gov.

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