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Procedure

BEAR Procedure for ACL Injury

N/A
Waitlist Available
Research Sponsored by Miach Orthopaedics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 5% of the ACL attached to the tibia
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time points up to two years
Awards & highlights

Study Summary

This trial is testing a new procedure to see if age is a risk factor in determining the success of the procedure.

Who is the study for?
The BEAR III Trial is for individuals who have recently (within 50 days) injured their ACL and still have at least 5% of the ligament attached to the tibia. It's not suitable for those with allergies to bovine products or gelatin, a BMI over 35, history of knee issues like infections or moderate osteoarthritis, prior knee surgery, tobacco use, or severe allergic reactions.Check my eligibility
What is being tested?
This trial tests the BEAR procedure where an implant soaked in the patient's blood aims to heal torn ACLs. The study focuses on whether age affects recovery by comparing outcomes using scores that measure knee function two years post-surgery.See study design
What are the potential side effects?
Potential side effects may include infection risks around the implant site, possible graft rejection which could lead to additional surgeries, and general complications associated with surgical procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
At least 5% of my ACL is attached to my shinbone.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~two years
This trial's timeline: 3 weeks for screening, Varies for treatment, and two years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
International Knee Documentation Committee Objective Score (IKDC) (Physical Exam)
International Knee Documentation Committee Subjective Score (IKDC) (Survey)
Secondary outcome measures
Knee Injury and Osteoarthritis Score (KOOS) questionnaire
Repair Failure

Trial Design

1Treatment groups
Experimental Treatment
Group I: Bridge-Enhanced ACL Restoration (BEAR)Experimental Treatment1 Intervention
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

Find a Location

Who is running the clinical trial?

Miach OrthopaedicsLead Sponsor
4 Previous Clinical Trials
1,070 Total Patients Enrolled

Media Library

Bridge-Enhanced ACL Restoration (BEAR) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03348995 — N/A
Anterior Cruciate Ligament Rupture Research Study Groups: Bridge-Enhanced ACL Restoration (BEAR)
Anterior Cruciate Ligament Rupture Clinical Trial 2023: Bridge-Enhanced ACL Restoration (BEAR) Highlights & Side Effects. Trial Name: NCT03348995 — N/A
Bridge-Enhanced ACL Restoration (BEAR) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03348995 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What qualifications are required for potential participants in this clinical research?

"This clinical trial is accepting 250 candidates that have suffered an anterior cruciate ligament injury and are between the ages of 12 to 80."

Answered by AI

How many people have taken part in this experiment thus far?

"This medical trial requires a cohort of 250 eligible individuals, who can be enrollees from multiple locations such as Emory University School Of Medicine in Johns Creek, Georgia and Ochsner Sports Medicine Institute in New Orleans, Louisiana."

Answered by AI

Are there still opportunities to join this program?

"Affirmative. Clinicaltrials.gov shows that the trial, which was first made public on April 17th 2018 and recently edited on May 24th 2022 is presently accepting applicants. At least 250 volunteers are needed between 8 distinct locations."

Answered by AI

Are there venues in Canada operating this research endeavor?

"Subjects are being recruited for this trial at Emory University School Of Medicine in Johns Creek, Georgia, Ochsner Sports Medicine Institute in New Orleans, Louisiana and Florida Orthopedic Institute in Tampa, Florida; with 8 other medical centres also participating."

Answered by AI

Does the current research project permit individuals below four decades of age to participate?

"The trial's parameters stipulate that the youngest participant must be 12 years old while the oldest can not exceed 80."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
Cynthia Chrostek
Orthopedic Institute
What portion of applicants met pre-screening criteria?
Met criteria

How responsive is this trial?

Typically responds via
Email
Most responsive sites:
  1. Orthopedic Institute: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration
2018. "The BEAR III Trial for Bridge-Enhanced ACL (Anterior Cruciate Ligament) Restoration". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03348995.
All > Rhode Island
~36 spots leftby May 2025
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