Recruiting

Operative vs. Non-operative

Sponsor:

Rush University Medical Center

Code:

NCT05985772

Conditions

Meniscus Tear, Tibial

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Non-Operative Pain Management

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

Study Details

Brief 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

Study ID

NCT05985772

Start date

Apr 20, 2022

Status verified date

Aug, 2026

Completion date

Mar, 2030

Anticipated

Primary completion date

Dec, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • MRI-verified isolated tibial medial meniscus root tear
  • Subject must be 18 years of age or older

Exclusion Criteria:

  • Concurrent ligamentous knee pathology requiring surgical intervention (i.e. anterior cruciate ligament tear, posterior cruciate ligament tear, posterolateral corner injury, high-grade medial collateral ligament tear),
  • Preoperative Kellgren-Lawrence grade of 3 or 4
  • Inability to complete outcome questionnaires or comply with required postoperative imaging or MRI requirements, or medical contraindications to surgery or physical therapy.
  • There will be no exclusion criteria regarding body mass index (BMI) or mechanical alignment, however subjects will be stratified in groups for further analysis (BMI less and over 35 and varus alignment below and over 3º of varus).
  • Pregnancy
  • Subjects < 18 years of age

Study Design

Enrollment

140 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

active comparator: Non-operative Control (ARM 1)

Subjects randomized to 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.

experimental: Operative Intervention (ARM 2)

Subjects randomized to the operative treatment arm will undergo transtibial medial meniscus root repair within 3 weeks of enrollment. All surgically treated subjects, regardless if repairs were performed acutely or after cross over, will receive identical postoperative rehabilitation.

Interventions

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.

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)

Primary outcome measure

  • Visual analogue scale (VAS) for pain [ Time Frame: Enrollment up to 12 months postoperatively (18 months if crossover at 3 months from ARM 1 to ARM 2) ]

Central Contacts and Locations

Central contacts

Carla M. Edwards, PhD

312-563-5735carla_edwards@rush.edu

Jorge Chahla, MD

(312) 432-2818jorge.chahla@rushortho.com

Locations

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Carla M Edwards, PhD

312-563-5735carla_edwards@rush.edu

Principal Investigator:

Jorge Chahla, MD, PhD

More Information

Sponsor

Rush University Medical Center

Last update posted

Aug 24, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Rush University Medical Center on 2026-08-24.