- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07388290
The Effect of Centralization on Medial Meniscal Extrusion for Medial Meniscus Posterior Root Tear Repair
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Colorado
-
West Vail, Colorado, United States, 81657
- The Steadman Clinic
-
-
Florida
-
Naples, Florida, United States, 34110
- Hospital for Special Surgery at Naples Comprehensive Health (HSS at NCH),
-
-
Minnesota
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Rochester, Minnesota, United States, 55902
- Mayo Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Type 2 Medial Meniscus Posterior Root Tear demonstrated on MRI
- Notable extrusion (>3 mm) on preoperative MRI
- Patient able to consent for themselves
- Patient agrees to comply with trial schedules and plan
Pre-operative Exclusion:
- Concomitant ligamentous or meniscal procedures
- Meniscal extrusion > 6 mm on pre-operative MRI
- Kellgren-Lawrence grade > 2
- Varus malalignment > 10 degrees
- Asymmetric varus alignment > 5 degrees
- Varus thrust while weightbearing
- Grade 3 bipolar medial compartment changes (isolated grade 3 changes on single articular surface with ≤ grade 2 changes on the opposing surface remains eligible)
- Previous surgery of the affected knee
- Associated fractures requiring surgery
- Concurrent Vascular injuries
- Hypermobility/Ehlers-Danlos Syndrome
- Inflammatory or autoimmune disease
- Severe mental/physical disability precluding post operative rehabilitation demands
- Contraindications to MRI
- Pregnant women
Arthroscopy Inclusion Criteria:
- Complete radial tears within 9 mm of medial meniscus posterior root
- ICRS Grade 3 or better
Arthroscopy Exclusion Criteria:
- Requiring concomitant procedures other than MMPRT
- ICRS Grade 4 changes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Repair with meniscus centralization
Medial meniscus posterior root tear (MMPRT) surgical repair with meniscus centralization
|
The centralization technique involves placement of 1.8-mm Knotless FiberTak suture anchors along the periphery of the tibial plateau, starting from the posteromedial corner and progressing anteriorly. The anchors are deployed using a curved drill guide, and sutures are passed in a mattress configuration to re-tension the meniscotibial ligament to centralize the meniscus. Once centralization is complete, the posterior root tear is repaired using an anatomic suture anchor for aperture medial meniscus root fixation. |
|
Active Comparator: Repair without centralization
Medial meniscus posterior root tear (MMPRT) surgical repair without centralization
|
The posterior root tear is repaired using an anatomic suture anchor for aperture medial meniscus root fixation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Meniscus extrusion measurement
Time Frame: Baseline (Preoperatively), 6 months
|
Meniscus extrusion is measured in millimeters (mm) on coronal MRI at the level of the tibial spine
|
Baseline (Preoperatively), 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Kellgren-Lawrence grade on X-ray
Time Frame: Baseline (Screening), 12 months, 24 months
|
The Kellgren-Lawrence (KL) system is a 0-4 scale used to grade the severity of knee osteoarthritis (OA) based on X-ray.
It ranges from Grade 0 (no changes) to Grade 4 (severe).
|
Baseline (Screening), 12 months, 24 months
|
|
Change in Tegner Activity Score
Time Frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
|
The Tegner Activity Questionnaire is a 1-item questionnaire rating physical activity from 0 (Disabled) to 10 (Elite competitive athlete).
Total scores range from 0 - 10, with higher scores indicating a higher level of activity.
|
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
|
|
Change in Visual Analog Scale (VAS) Questionnaire score
Time Frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
|
The VAS is a 2-item questionnaire assessing pain using a scale of 0 (No pain) to 10 (Worst pain).
Total scores range from 0 - 10, lower scores indicating lower pain and higher scores indicating greater pain.
|
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
|
|
Change in Knee Injury and Osteoarthritis Outcome Score Jr. (KOOS, JR) Questionnaire score
Time Frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
|
The KOOS JR is a questionnaire designed to measure outcomes for patients with knee replacements.
Questions focus on knee stiffness, pain, and function for daily activities and are assessed on a 5 point Likert-scale between 0 (None) and 4 (Extreme).
Total scores range from 0 - 28, with higher scores indicating a greater impact of pain on daily functioning.
|
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
|
|
Change in International Knee Documentation Committee (IKDC) Questionnaire score
Time Frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
|
The International Knee Documentation Committee (IKDC) Subjective Knee Evaluation assesses overall function over 3 domains: symptoms, athletic activity, and knee function.
Higher scores indicate higher levels of function and lower levels of symptoms.
|
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
|
|
Change in Likert Knee Questionnaire score
Time Frame: Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
|
The Likert Knee Questionnaire is a 1-item survey asking the patient to rate knee pain post-surgery on a Likert scale where 0 (Much better than before surgery) and 5 (Much worse than before surgery).
|
Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
|
|
Surgery Satisfaction Questionnaire
Time Frame: 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
|
The Surgery Satisfaction Questionnaire is a 1-item survey asking the patient to rate satisfaction with knee surgery on a Likert scale where 0 (Not at all) and 10 (Most Satisfied).
|
2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aaron J. Krych, MD, Mayo Clinic
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25-011455
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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