48 Participants NeededMy employer runs this trial

Medial Unloader Brace for Meniscus Root Tear Repair

NO
AW
Overseen ByAndrew White
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: NYU Langone Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this study is to evaluate whether medial unloader bracing improves healing and clinical outcomes following arthroscopic medial meniscus posterior root repair. The primary aim is to compare 5-month MRI-based healing rates, meniscal extrusion, and cartilage changes between patients who use a medial unloader brace and those who do not following medial meniscus posterior root repair.

Who Is on the Research Team?

ES

Eric Strauss

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for people who have had surgery to repair the back root of their medial meniscus in the knee. Participants should be able to wear a knee brace and follow post-surgery care instructions. People with other major knee problems or conditions that prevent brace use cannot join.

Inclusion Criteria

Willingness and ability to comply with postoperative rehabilitation protocols and study follow-up visits
Medically appropriate candidate for use of a medial unloader valgus knee brace, as determined by the treating surgeon
Willingness and ability to undergo postoperative MRI imaging as part of routine follow-up
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Exclusion Criteria

Contraindication to MRI imaging (e.g., non-MRI compatible implants, severe claustrophobia)
Known allergy or intolerance to materials used in medial unloader valgus knee braces
Inability to comply with postoperative rehabilitation or study follow-up requirements, in the opinion of the investigator
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What Are the Treatments Tested in This Trial?

Interventions

  • Medial unloader valgus knee brace

Trial Overview

The study compares patients who use a special knee brace called a medial unloader after meniscus root repair surgery to those who do not use the brace, looking at healing on MRI scans and changes in cartilage over five months.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: Medial unloader valgus knee braceExperimental Treatment1 Intervention
Group II: Standard of care management without use of the braceActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials
1,431
Recruited
838,000+