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Procedure

BEAR Implant for Meniscus Tears

N/A

Waitlist Available

Led By Guillem Gonzalez-Lomas, MD Gonzalez-Lomas, MD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 year post-procedure

Awards & highlights

Study Summary

This trial compares outcomes of knee meniscus repair surgery with and without a special implant to help promote healing.

Who is the study for?

This trial is for individuals with meniscus injuries that need repair but don't require other knee procedures like ligament reconstruction. Participants must not have blood-borne diseases such as HIV, hepatitis B or C, human T-lymphotropic virus, and syphilis.Check my eligibility

What is being tested?

The study tests a new BEAR implant against standard meniscal repair procedures. The BEAR implant uses a collagen scaffold with the patient's own blood to encourage healing in the knee joint.See study design

What are the potential side effects?

Potential side effects are not specified in the provided information. Generally, risks may include typical surgical complications such as infection, bleeding, or adverse reactions to materials used.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 year post-procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 year post-procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 year post-procedure for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score

Change in Lysholm Scale Score

Change in Visual Analogue Scale (VAS) Score

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BEAR ImplantExperimental Treatment2 Interventions

Adult patients with meniscus injury indicated for isolated meniscus repair. In the experimental group, the BEAR Implant will be utilized in the repair procedure.

Group II: Standard RepairActive Control1 Intervention

adult patients with meniscus injury indicated for isolated meniscus repair. In the standard repair group, participants will undergo an isolated meniscus repair without the implant.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,367 Previous Clinical Trials

839,681 Total Patients Enrolled

Guillem Gonzalez-Lomas, MD Gonzalez-Lomas, MDPrincipal InvestigatorNYU Langone Health

Frequently Asked Questions

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

Does this research accept octogenarian participants?

"This research is soliciting volunteers that are 18 years of age or older, and not yet 75."

Answered by AI

Is recruitment open for the current research project?

"According to the data available on clinicaltrials.gov, this trial has recently concluded its recruitment phase and is not actively seeking out participants. Originally posted on October 1st 2023, it was last modified on September 12th 23rd. However, there are currently 17 different studies that do require volunteers at this time."

Answered by AI

What processes do I need to follow in order to participate in this medical research?

"To qualify for this medical trial, the prospective participants must have a diagnosed meniscal tear and be between 18 to 75 years old. The study is currently aiming to recruit 80 patients in total."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Bridge-Enhanced ACL Repair (BEAR) in Meniscus Repair

2024. "Bridge-Enhanced ACL Repair (BEAR) in Meniscus Repair". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06041763.