Medial unloader brace after root repair

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults aged 18–60 undergoing arthroscopic medial meniscus posterior root repair are randomly or prospectively assessed to see if wearing a medial unloader valgus knee brace after surgery improves MRI-determined healing at 5 months, reduces meniscal extrusion, and affects cartilage changes compared with not using the brace. The trial uses MRI assessments and clinical follow-up to evaluate structural and clinical outcomes after postoperative rehab. The study is conducted at NYU Langone Health with standard postoperative care plus brace use as the intervention. Enrollment requires willingness to follow rehabilitation, undergo postoperative MRI, and comply with follow-up visits.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18-60 years at the time of enrollment.
2. Undergoing arthroscopic medial meniscus posterior root repair performed by a study investigator.
3. Willingness and ability to comply with postoperative rehabilitation protocols and study follow-up visits.
4. Willingness and ability to undergo postoperative MRI imaging as part of routine follow-up.
5. Ability to understand the study procedures and provide informed consent.
6. Ambulatory prior to surgery and expected to resume weightbearing as part of standard postoperative care.
7. Medically appropriate candidate for use of a medial unloader valgus knee brace, as determined by the treating surgeon.

Exclusion Criteria:

1. Age less than 18 or greater than 60 years.
2. Inability or unwillingness to provide informed consent.
3. Prior surgery on the ipsilateral knee that would interfere with assessment of meniscal healing or extrusion.
4. Concomitant ligamentous injury requiring reconstruction at the time of meniscal root repair (e.g., anterior cruciate ligament (ACL) or Posterior Cruciate Ligament (PCL) reconstruction).
5. Advanced medial compartment osteoarthritis, defined as Kellgren-Lawrence grade 4.
6. Contraindication to MRI imaging (e.g., non-MRI compatible implants, severe claustrophobia).
7. Known allergy or intolerance to materials used in medial unloader valgus knee braces.
8. Neurologic, musculoskeletal, or medical conditions that would preclude safe brace use or interfere with gait mechanics.
9. Inability to comply with postoperative rehabilitation or study follow-up requirements, in the opinion of the investigator.
10. Pregnancy at the time of enrollment (not eligible for surgery).

Where it's running

• NYU Langone Health
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Eric Strauss — NYU Langone Health
• Study coordinator: Nicole Oberlag
• Email: Nicole.oberlag@nyulangone.org
• Phone: 720-326-9831

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.