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Enrolling by invitation NCT07388290

The Effect of Centralization on Medial Meniscal Extrusion for Medial Meniscus Posterior Root Tear Repair

No phase Interventional Meniscus Tear

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Medial meniscus posterior root tear (MMPRT) repair with meniscus centralization, Medial meniscus posterior root tear (MMPRT) repair without meniscus centralization.
Who it may be relevant to
Registry conditions: Meniscus Tear. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

The purpose of this research is to determine if meniscus root repair with or without centralization will have an impact on postoperative pain, function, activity levels, patient satisfaction, and incidence of revision meniscus surgery.

Interventions

  • Procedure Medial meniscus posterior root tear (MMPRT) 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 meni
  • Procedure Medial meniscus posterior root tear (MMPRT) repair without meniscus centralization
    The posterior root tear is repaired using an anatomic suture anchor for aperture medial meniscus root fixation.

Primary outcome measures

  • Meniscus extrusion measurement [Time frame: Baseline (Preoperatively), 6 months]
Secondary outcome measures (7)
  • Change in Kellgren-Lawrence grade on X-ray [Time frame: 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]
  • Change in Visual Analog Scale (VAS) Questionnaire score [Time frame: 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]
  • Change in International Knee Documentation Committee (IKDC) Questionnaire score [Time frame: 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]
  • Surgery Satisfaction Questionnaire [Time frame: 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • The Steadman Clinic — West Vail
  • Hospital for Special Surgery at Naples Comprehensive Health (HSS at NCH), — Naples
  • Mayo Clinic — Rochester

Identifiers

NCT: NCT07388290 · 25-011455

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗