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Procedure

BEAR Device vs. Autograft for ACL Tear (BEAR-MOON Trial)

N/A

Recruiting

Led By Kurt P Spindler, MD

Research Sponsored by The Cleveland Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Selected surgical treatment of ACL injury

18-55 years of age

Timeline

Screening 3 weeks

Treatment Varies

Follow Up kt-1000 instrumented knee laxity measure 2 years after surgery (difference from contralateral knee)

Awards & highlights

BEAR-MOON Trial Summary

This trial is designed to compare the effectiveness of two different surgical techniques for repairing a torn ACL. One technique, called BEAR, is new and involves placing a sponge between the torn ends of the ACL to provide a scaffold for the ligament to grow. The other technique, called BPTB, is the standard ACL surgery that replaces the torn portion of the ACL with transplanted patellar tendon tissue. The trial will conclude before any long-term benefits can be observed.

Who is the study for?

This trial is for individuals aged 18-55 who have a complete ACL tear confirmed by MRI and are within 50 days of their injury. They must be considered candidates for ACL surgery, agree to follow study procedures including activity restrictions, and provide informed consent.Check my eligibility

What is being tested?

The study compares two surgical techniques for repairing torn ACLs: the new BEAR method using a blood-enriched implant to promote healing, versus the traditional BPTB reconstruction that uses transplanted patellar tendon tissue.See study design

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include pain at the surgery site, infection risk from surgery, knee stiffness or weakness during recovery. The BEAR method aims to reduce invasive surgery burden.

BEAR-MOON Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have chosen surgery for my ACL injury.

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I am between 18 and 55 years old.

BEAR-MOON Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ active knee range of motion 2 years after surgery

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~active knee range of motion 2 years after surgery

This trial's timeline: 3 weeks for screening, Varies for treatment, and active knee range of motion 2 years after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

IKDC (International Knee Documentation Committee) Score

KT-1000

Secondary outcome measures

Active Knee Range of Motion

Knee

Hop Test Limb Difference

+6 more

BEAR-MOON Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Bridge Enhanced ACL RestorationExperimental Treatment1 Intervention

Procedure/Surgery Bridge Enhanced ACL Restoration (BEAR): The surgical repair of the ACL using the BEAR technique involves surgically placing a sponge (the BEAR implant) between the torn ends of the ACL, providing a sponge for the ligament ends to group into.

Group II: ACL Reconstruction(BPTB Graft)Active Control1 Intervention

Procedure/Surgery ACL Reconstruction (Bone Patellar Tendon Bone Graft): Standard of care surgical procedure Patellar Tendon Autograft ACL reconstruction, in which a bone-patellar tendon-bone graft from the front of the knee is taken to replace the torn ACL.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Cleveland ClinicLead Sponsor

1,029 Previous Clinical Trials

1,364,878 Total Patients Enrolled

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH

484 Previous Clinical Trials

1,086,807 Total Patients Enrolled

1 Trials studying Anterior Cruciate Ligament Tear

40 Patients Enrolled for Anterior Cruciate Ligament Tear

Miach OrthopaedicsIndustry Sponsor

4 Previous Clinical Trials

1,120 Total Patients Enrolled

2 Trials studying Anterior Cruciate Ligament Tear

120 Patients Enrolled for Anterior Cruciate Ligament Tear

Media Library

ACL Reconstruction (Bone Patellar Tendon Bone Graft) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03776162 — N/A

Anterior Cruciate Ligament Tear Research Study Groups: ACL Reconstruction(BPTB Graft), Bridge Enhanced ACL Restoration

Anterior Cruciate Ligament Tear Clinical Trial 2023: ACL Reconstruction (Bone Patellar Tendon Bone Graft) Highlights & Side Effects. Trial Name: NCT03776162 — N/A

ACL Reconstruction (Bone Patellar Tendon Bone Graft) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03776162 — N/A

Frequently Asked Questions

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

What demographic of participants are eligible to be involved in this experiment?

"This trial is accepting applicants aged between 18 and 55 that have a torn Anterior Cruciate Ligament. A total of 200 individuals will be enrolled in this experiment."

Answered by AI

Are volunteers being recruited to join this clinical trial at present?

"Affirmative, the information accessible from clinicaltrials.gov shows that this medical experiment is presently looking for volunteers; it was launched on August 30th 2021 and last updated October 31st 2022. The researchers are searching to enlist 200 individuals across 6 sites."

Answered by AI

What is the scope of participants in this research endeavor?

"In order to complete this medical trial, 200 participants meeting the specified criteria need to be enrolled. These individuals can take part in locations such as TRIA Orthopaedics Center/University of Minnesota in Bloomington and University of Colorado in Boulder."

Answered by AI

How widely distributed is this trial across the United States?

"Participants can join this clinical trial at TRIA Orthopaedics Center/ University of Minnesota in Bloomington, Minnesota, University of Colorado in Boulder, Colorado and Vanderbilt University in Nashville Tennessee along with 6 additional sites."

Answered by AI

What does the research team hope to accomplish with this venture?

"Per the study sponsor, Miach Orthopaedics, primary measurements observational over a two-year period following surgery will be evaluated with KT-1000. Secondary outcomes to be assessed include Number of Participants with Knee Infection; MARX Activity (Marx Activity Rating Scale); and Hop Test Limb Difference. The latter entails quantifying any disparity between hop distances utilising the normal leg compared to that of an ACL injured one."

Answered by AI

Does this experiment include a cohort of participants aged 30 and over?

"This clinical trial has a participant age range of 18 to 55 years old. Those who are younger than 18 can join the 47 pre-established trials and those over 65 can participate in 25 other studies."

Answered by AI