Recruiting

Medial Unloader Brace

Sponsor:

NYU Langone Health

Code:

NCT07909369

Conditions

Arthroscopic Medial Meniscus Posterior Root Repair

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Medial unloader valgus knee brace

Study Details

Brief summary:

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.

Conditions

Arthroscopic Medial Meniscus Posterior Root Repair

Study ID

NCT07909369

Start date

Oct 19, 2026

Status verified date

Oct, 2026

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Nov 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Medial unloader valgus knee brace

Standard postoperative care following medial meniscus posterior root repair with the addition of a medial unloader valgus knee brace during ambulation beginning at approximately 1-2 weeks postoperatively, following resumption of weightbearing.

no intervention: Standard of care management without use of the brace

Standard postoperative care following medial meniscus posterior root repair without use of a medial unloader valgus knee brace after resumption of weightbearing.

Interventions

Medial unloader valgus knee brace

Commercially available orthopedic device designed to reduce load across the medial compartment of the knee by applying an external valgus force during weightbearing.

Primary outcome measure

  • Change in medial meniscal extrusion on coronal T2-weighted MRI at 5 months as defined by greater than 3 mm of extrusion from the tibial plateau. [ Time Frame: Baseline, Month 5 ]

Central Contacts and Locations

Locations

NYU Langone Health

Recruiting

New York, New York, United States, 10016

More Information

Sponsor

NYU Langone Health

Last update posted

Nov 2, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-03. This information was provided to ClinicalTrials.gov by NYU Langone Health on 2026-11-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.