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Enrolling by Invitation

NCT Number: NCT07388290

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

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.

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Key information

Conditions

Meniscus Tear

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Steadman Clinic, West Vail, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medial meniscus posterior root tear (MMPRT) repair with meniscus centralization

Procedure

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.

Medial meniscus posterior root tear (MMPRT) repair without meniscus centralization

Procedure

The posterior root tear is repaired using an anatomic suture anchor for aperture medial meniscus root fixation.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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).

  7. 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).

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Feb 5, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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