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Operative vs Non-operative Management of Posterior-medial Meniscal Root Tears: A Randomized Multicenter Trial (RCT)

NCT05985772 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2025-08-21

No results posted yet for this study

Summary

The purpose of this study is to determine differences in pain, functional patient reported outcomes, and objective imaging parameters following non-operative and meniscus root repair treatment. Furthermore, the long-term goal of this research proposal is to understand the natural history of meniscal root tears and their subsequent repair, in order to better determine risk factors for inferior outcomes and progression to osteoarthritis (OA).

Conditions

  • Meniscus Tear, Tibial

Interventions

OTHER

Non-Operative Pain Management

The non-operative treatment arm will receive analgesics, physical therapy and will remain non-weight bearing. This will consist in anti-inflammatory drugs daily for 8-12 weeks and supervised physical therapy at least twice a week over a period of 8 weeks. Subjects in the non-operative arm will be offered the opportunity to crossover to the operative arm (ARM 2) of the study if the subjects do not report symptomatic improvement within 3 months after entry in this study.

PROCEDURE

Operative treatment arm will undergo transtibial medial meniscus root repair within 3 weeks of enrollment

The operative treatment group (ARM 2) will be treated acutely with a transtibial medial meniscus root repair and will be non-weight bearing for 6 weeks as well. For ARM 1 subjects if no subjective improvement is seen at 3 months, crossover will be allowed to a transtibial medial meniscal root repair (acute operative pathway (ARM 2)

Sponsors & Collaborators

  • International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine (ISAKOS)

    collaborator UNKNOWN

  • Rush University Medical Center

    lead OTHER

Principal Investigators

  • Jorge Chahla, MD · Rush University Medical Center Associate Professor and Surgeon

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-20
Primary Completion
2027-12-31
Completion
2028-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05985772 on ClinicalTrials.gov