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

NCT ID: NCT03348995

Last Updated: 2025-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-17

Study Completion Date

2034-04-17

Brief Summary

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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.

Detailed Description

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The BEAR III study is a cohort study designed to determine if age is a risk factor for a worse outcome after a bridge-enhanced ACL restoration (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

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Anterior Cruciate Ligament Injury Anterior Cruciate Ligament Rupture

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Cohort Study
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bridge-Enhanced ACL Restoration (BEAR)

The BEAR technique involves surgically placing an absorbable implant (the BEAR Implant) between the torn ends of the ACL, providing a scaffold for the ligament ends to grow into

Group Type EXPERIMENTAL

Bridge-Enhanced ACL Restoration (BEAR)

Intervention Type DEVICE

In the BEAR Procedure, surgery is performed to sew the ACL back together and a scaffold is placed between the torn ends at the time of repair.

Interventions

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Bridge-Enhanced ACL Restoration (BEAR)

In the BEAR Procedure, surgery is performed to sew the ACL back together and a scaffold is placed between the torn ends at the time of repair.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

12 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Miach Orthopaedics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Scripps Health

San Diego, California, United States

Site Status

Florida Orthopedic Institute

Tampa, Florida, United States

Site Status

Emory University School Of Medicine

Atlanta, Georgia, United States

Site Status

Ochsner Sports Medicine Institute

New Orleans, Louisiana, United States

Site Status

MedStar Health Surgery Center of Timonium

Lutherville, Maryland, United States

Site Status

Boston Children's Hospital

Boston, Massachusetts, United States

Site Status

Virtua Health

Marlton, New Jersey, United States

Site Status

Cynthia Chrostek

Providence, Rhode Island, United States

Site Status

Orthopedic Institute of Sioux Falls

Sioux Falls, South Dakota, United States

Site Status

UT Southwestern

Dallas, Texas, United States

Site Status

Inova Sports Medicine

Fairfax, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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BEAR III Trial

Identifier Type: -

Identifier Source: org_study_id

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