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

NCT05985772 | Recruiting

• 1 other identifier: 19082802
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale (VAS) for pain

  The Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line.

  Enrollment up to 12 months postoperatively (18 months if crossover at 3 months from ARM 1 to ARM 2)

Secondary Outcomes (4)

• Western Ontario Meniscal Evaluation Tool (WOMET)

  Enrollment up to 12 months postoperatively (18 months if crossover at 3 months from ARM 1 to ARM 2)

• Knee Osteoarthritis and Outcomes Score (KOOS)

  Enrollment up to 12 months postoperatively (18 months if crossover at 3 months from ARM 1 to ARM 2)

• European Quality of Life Scale (Euro-QoL)

  Enrollment up to 12 months postoperatively (18 months if crossover at 3 months from ARM 1 to ARM 2)

• Lysholm knee score

  Enrollment up to 12 months postoperatively (18 months if crossover at 3 months from ARM 1 to ARM 2)

Study Arms (2)

Non-operative Control (ARM 1)

ACTIVE COMPARATOR

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.

Other: Non-Operative Pain Management

Operative Intervention (ARM 2)

EXPERIMENTAL

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.

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

Interventions

Non-Operative Pain Management OTHER

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.

Non-operative Control (ARM 1)

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

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)

Operative Intervention (ARM 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.
• Pregnancy
• Subjects \< 18 years of age

Sponsors & Collaborators

• Rush University Medical Center: lead
• International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine (ISAKOS): collaborator

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612, United States

RECRUITING

MeSH Terms

Conditions

Tibial Meniscus Injuries

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries

Study Officials

• Jorge Chahla, MD

  Rush University Medical Center Associate Professor and Surgeon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carla M. Edwards, PhD

CONTACT

312-563-5735; carla_edwards@rush.edu

Jorge Chahla, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Randomization will be structured so that surgeons at all sites are contributing an equal number of subjects to the non-operative and operative treatment arms, to mitigate the chance that differences in outcomes between the groups are confounded by variability in surgeon skill and technique. Randomization groups will be delivered by means of sealed opaque envelopes. Surgeons(Investigators) will be masked to the group assignment.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a pragmatic design, parallel group, randomized clinical trial in which 140 subjects with a diagnosed medial meniscus root tear based on MRI and confirmed intra-operatively will be randomized to one of two treatment arms.

Study Record Dates

• First Submitted: August 2, 2023
• First Posted: August 14, 2023
• Study Start: April 20, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): March 1, 2028
• Last Updated: August 21, 2025

Record last verified: 2025-08

Locations

US (1)