NCT07388290

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
46mo left

Started Feb 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Feb 2026Mar 2030

First Submitted

Initial submission to the registry

January 28, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

February 17, 2026

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2028

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2030

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2.5 years

First QC Date

January 28, 2026

Last Update Submit

April 8, 2026

Conditions

Meniscus Tear

Keywords

Meniscus tearMeniscus extrusionMedial meniscus root repairMeniscus centralization

Outcome Measures

Primary Outcomes (1)

  • Meniscus extrusion measurement

    Meniscus extrusion is measured in millimeters (mm) on coronal MRI at the level of the tibial spine

    Baseline (Preoperatively), 6 months

Secondary Outcomes (7)

  • Change in Kellgren-Lawrence grade on X-ray

    Baseline (Screening), 12 months, 24 months

  • Change in Tegner Activity Score

    Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months

  • Change in Visual Analog Scale (VAS) Questionnaire score

    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

    Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months

  • Change in International Knee Documentation Committee (IKDC) Questionnaire score

    Baseline, 2 weeks, 6 weeks, 3 months, 6 months, 12 months, 24 months

  • +2 more secondary outcomes

Study Arms (2)

Repair with meniscus centralization

EXPERIMENTAL

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

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

Repair without centralization

ACTIVE COMPARATOR

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

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

Interventions

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

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.

Repair with meniscus centralization
Medial meniscus posterior root tear (MMPRT) repair without meniscus centralizationPROCEDURE

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

Repair without centralization

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

The Steadman Clinic

West Vail, Colorado, 81657, United States

Location

Hospital for Special Surgery at Naples Comprehensive Health (HSS at NCH),

Naples, Florida, 34110, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

MeSH Terms

Interventions

Wound Healing

Intervention Hierarchy (Ancestors)

RegenerationBiological Phenomena

Study Officials

  • Aaron J. Krych, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 28, 2026

First Posted

February 5, 2026

Study Start

February 17, 2026

Primary Completion (Estimated)

September 1, 2028

Study Completion (Estimated)

March 1, 2030

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(3)