Bridge-Enhanced ACL Restoration (BEAR) for Anterior Cruciate Ligament Rupture

Phase-Based Progress Estimates
Rhode Island Hospital, Providence, RIAnterior Cruciate Ligament Rupture+1 MoreBridge-Enhanced ACL Restoration (BEAR) - Device
12 - 80
All Sexes
What conditions do you have?

Study Summary

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

Eligible Conditions
  • Anterior Cruciate Ligament (ACL) Injury
  • Anterior Cruciate Ligament (ACL) Rupture

Treatment Effectiveness

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Time points up to two years

Time points up to two years
International Knee Documentation Committee Subjective Score (IKDC) (Survey)
Knee Injury and Osteoarthritis Score (KOOS) questionnaire
Time points up to two years.
International Knee Documentation Committee Objective Score (IKDC) (Physical Exam)
Two years
Repair Failure

Trial Safety

Trial Design

1 Treatment Group

Bridge-Enhanced ACL Restoration (BEAR)
1 of 1

Experimental Treatment

250 Total Participants · 1 Treatment Group

Primary Treatment: Bridge-Enhanced ACL Restoration (BEAR) · No Placebo Group · N/A

Bridge-Enhanced ACL Restoration (BEAR)
Experimental Group · 1 Intervention: Bridge-Enhanced ACL Restoration (BEAR) · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: time points up to two years

Who is running the clinical trial?

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

Eligibility Criteria

Age 12 - 80 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have to have at least 5% of the ligament connecting the shinbone (tibia) to the thigh bone (femur) intact.
You have a torn ACL (a ligament in your knee).
You have had an injury within the last 50 days.

Who else is applying?

How old are they?
18 - 65100.0%
What site did they apply to?
Orthopedic Institute100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Typically responds via
Most responsive sites:
  1. Orthopedic Institute: < 24 hours
Average response time
  • < 1 Day

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

Are there still opportunities to join this program?

"Affirmative. 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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.