Arthroscopic Medial Meniscus Posterior Root RepairNCT07909369
Medial Unloader Brace After Root Repair
A study testing Medial unloader valgus knee brace in people with Arthroscopic Medial Meniscus Posterior Root Repair, run by NYU Langone Health at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Arthroscopic Medial Meniscus Posterior Root Repair
- What is being tested?
- Medial unloader valgus knee brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Oct 2026to 1 Mar 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years at the time of enrollment.
- Undergoing arthroscopic medial meniscus posterior root repair performed by a study investigator.
- Willingness and ability to comply with postoperative rehabilitation protocols and study follow-up visits.
- Willingness and ability to undergo postoperative MRI imaging as part of routine follow-up.
- Ability to understand the study procedures and provide informed consent.
- Ambulatory prior to surgery and expected to resume weightbearing as part of standard postoperative care.
- Medically appropriate candidate for use of a medial unloader valgus knee brace, as determined by the treating surgeon.
Who cannot join
- Age less than 18 or greater than 60 years.
- Inability or unwillingness to provide informed consent.
- Prior surgery on the ipsilateral knee that would interfere with assessment of meniscal healing or extrusion.
- Concomitant ligamentous injury requiring reconstruction at the time of meniscal root repair (e.g., anterior cruciate ligament (ACL) or Posterior Cruciate Ligament (PCL) reconstruction).
- Advanced medial compartment osteoarthritis, defined as Kellgren-Lawrence grade 4.
- Contraindication to MRI imaging (e.g., non-MRI compatible implants, severe claustrophobia).
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- Known allergy or intolerance to materials used in medial unloader valgus knee braces.
- Neurologic, musculoskeletal, or medical conditions that would preclude safe brace use or interfere with gait mechanics.
- Inability to comply with postoperative rehabilitation or study follow-up requirements, in the opinion of the investigator.
- Pregnancy at the time of enrollment (not eligible for surgery).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
NYU Langone Health
New York, New York, 10016
About this study
Official title: Medial Unloader Brace Impact on Clinical Outcomes Following Meniscus Repair
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.
- Being tested
- Medial unloader valgus knee brace
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medial unloader valgus knee braceDevice
Commercially available orthopedic device designed to reduce load across the medial compartment of the knee by applying an external valgus force during weightbearing.
| Study group | Role | What they receive |
|---|---|---|
| Medial unloader valgus knee brace | Experimental | 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. Receives: Device: Medial unloader valgus knee brace |
| Standard of care management without use of the brace | No intervention | Standard postoperative care following medial meniscus posterior root repair without use of a medial unloader valgus knee brace after resumption of weightbearing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Month 5
Secondary outcomes (8)
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
The KOOS survey is comprised of 42 questions. The questions are divided into 5 sub-categories: symptoms (7 questions), pain (9 questions), function/daily living (17 questions), function/sports and recreational activities (5 questions), and quality of life (4 questions). The total range for each sub-category is 0-100, making the total range for the whole survey 0-500. The higher the score, the worse the symptoms and pain/ higher difficulty in function.
Measured: Baseline, Month 5
Change in Lysholm knee scoring scale
The Lysholm knee scoring scale is a 100-point patient-reported questionnaire designed to assess functional knee ligament injuries. It evaluates eight areas-limp, support, locking, instability, pain, swelling, stair climbing, and squatting-with higher scores (up to 100) indicating better function.
Measured: Baseline, Month 5
Change in Tegner Activity Scale (TAS)
The TAS is a self-administered patient-reported measure that describes the level of work- and sports-based activity in which a patient can engage. The TAS is a one-item questionnaire that is scored on an 11-item scale (0 to 10) based on the patient's reported level of activity/work. A level of 0 represents maximum disability while a level of 10 represents elite sports athletes.
Measured: Baseline, Month 5
Change in Visual Analogue Scale (VAS) for Pain score
VAS is a tool widely used to measure pain. A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 10 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (no pain) to 10 (worst pain imaginable); the higher the score, the worse the pain.
Measured: Baseline, Month 5
Change in medial femoral condyle cartilage thickness
Measured: Baseline, Month 5
Change in tibial plateau cartilage thickness
Measured: Baseline, Month 5
Number of participants who could not tolerate the brace
Measured: End of study (Up to 5 months)
Rate of reoperation
Measured: End of study (Up to 5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start19 Oct 2026
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroscopic Medial Meniscus Posterior Root RepairStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Strauss, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07909369
- Sponsor's protocol ID
- 25-01325
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset will be shared upon request immediately following publication - no end date - provided the requesting individual executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: nicole.oberlag@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Medial Unloader Brace Impact on Clinical Outcomes Following Meniscus Repair
- ClinicalTrials.gov ID
- NCT07909369
- Acronym / sponsor ID
- 25-01325
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 19 Oct 2026 (actual)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 2 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medial unloader valgus knee brace | Experimental | Device: Medial unloader valgus knee braceStandard 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. |
| Standard of care management without use of the brace | No intervention | –Standard postoperative care following medial meniscus posterior root repair without use of a medial unloader valgus knee brace after resumption of weightbearing. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age 18-60 years at the time of enrollment.
- Undergoing arthroscopic medial meniscus posterior root repair performed by a study investigator.
- Willingness and ability to comply with postoperative rehabilitation protocols and study follow-up visits.
- Willingness and ability to undergo postoperative MRI imaging as part of routine follow-up.
- Ability to understand the study procedures and provide informed consent.
Key exclusion criteria (10 listed)
- Age less than 18 or greater than 60 years.
- Inability or unwillingness to provide informed consent.
- Prior surgery on the ipsilateral knee that would interfere with assessment of meniscal healing or extrusion.
- Concomitant ligamentous injury requiring reconstruction at the time of meniscal root repair (e.g., anterior cruciate ligament (ACL) or Posterior Cruciate Ligament (PCL) reconstruction).
- Advanced medial compartment osteoarthritis, defined as Kellgren-Lawrence grade 4.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medial unloader valgus knee braceCommercially available orthopedic device designed to reduce load across the medial compartment of the knee by applying an external valgus force during weightbearing. | Device | Medial unloader valgus knee brace |
Primary outcome
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
8 secondary outcomes
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Baseline, Month 5
Change in Lysholm knee scoring scale
Time frame: Baseline, Month 5
Change in Tegner Activity Scale (TAS)
Time frame: Baseline, Month 5
Change in Visual Analogue Scale (VAS) for Pain score
Time frame: Baseline, Month 5
Change in medial femoral condyle cartilage thickness
Time frame: Baseline, Month 5
Change in tibial plateau cartilage thickness
Time frame: Baseline, Month 5
Number of participants who could not tolerate the brace
Time frame: End of study (Up to 5 months)
Rate of reoperation
Time frame: End of study (Up to 5 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset will be shared upon request immediately following publication - no end date - provided the requesting individual executes a data use agreement with NYU Langone Health. This instance of data sharing will also require separate IRB review as well as review from NYU Langone's Data Sharing Strategy Board (DSSB). Requests should be directed to: nicole.oberlag@nyulangone.org. The protocol and statistical analysis plan will be posted on Clinicaltrials.gov only as required by federal regulation or supporting awards and agreements.
Related trials for Arthroscopic Medial Meniscus Posterior Root Repair
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Hemi-tibial Plateau Osteotomy Combined With Arthroscopic Repair for Medial Meniscus Posterior Root Tears in Varus Knees
Knee Osteoarthristis, Meniscus Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric Strauss principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medial unloader valgus knee brace in people with Arthroscopic Medial Meniscus Posterior Root Repair, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Oberlag (720-326-9831, Nicole.oberlag@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.