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

Meniscus Tear, Tibial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05985772
• Other study ID #: 19082802
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2022
• Est. completion date: March 2026

Study information

• Verified date: August 2023
• Source: Rush University Medical Center
• Contact: Carla M. Edwards, PhD
• Phone: 312-563-5735
• Email: carla_edwards[@]rush.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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. The first group (ARM 1) will be treated non-operatively with analgesics, physical therapy, and will be kept non-weight bearing for 6 weeks (to match the postoperative protocol). 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) (CONSORT Flow Diagram)) as determined by 3 month patient reported outcomes (PROs and operating study physician approval.

The second 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. A previously published protocol will be used to standardize the rehabilitation. (14) Subjects will be followed with patient reported outcomes, serial radiographs (3 views), and a magnetic resonance imaging (MRI) scan at 12 months to determine repair status, meniscal extrusion, and presence of degenerative changes. Subjects who crossover at 3 months will be evaluated using additional MRI imaging prior to assignment to the acute operative meniscal root repair pathway (ARM 2). These subjects will crossover from ARM 1 to ARM 2 without first performing the ARM 1, 3 month radiograph (x-rays-3 views). The 3-month radiograph (x-rays-3 views) will be performed 3 months post-operative.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: March 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Meniscus Tear, Tibial
• Tibial Meniscus Injuries

Intervention

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)

Locations

Country	Name	City	State
United States	Rush University Medical Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Rush University Medical Center	International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine (ISAKOS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Western Ontario Meniscal Evaluation Tool (WOMET)	We will measure symptoms of osteoarthritis (OA) of the knee using the Western Ontario Meniscal Evaluation Tool (WOMET). The instrument has 16 items representing the domains of physical symptoms (nine items), sports/recreation/work/lifestyle (four items), and emotions (three items).This instrument has been validated for additional meniscal injury etiologies including degenerative tears.	Enrollment up to 12 months postoperatively (18 months if crossover at 3 months from ARM 1 to ARM 2)
Secondary	Knee Osteoarthritis and Outcomes Score (KOOS)	The KOOS is a 42-item knee-specific questionnaire with five separately reported domains, including pain (9 items), other symptoms (7 items), function in daily living (17 items), function in sports/recreation (5 items) and knee-related quality of life (4 items). Domain scores represent the average of all items in the domain standardized to a score from 0 to 100. This instrument has face validity and has demonstrated construct validity, excellent test-retest reliability for each domain (range, 0.75 to 0.93) and has been shown to be responsive to change in patients with knee osteoarthritis (OA).	Enrollment up to 12 months postoperatively (18 months if crossover at 3 months from ARM 1 to ARM 2)
Secondary	European Quality of Life Scale (Euro-QoL)	The EuroQol (EQ) comprises two sections, the EQ-5D(5 level digit) index and the EQ-5D visual analogue scale (VAS). The EQ-5D index is a 5 item standardized generic measure of HRQOL that includes domains of mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each item is scored using a 3-point response scale and each combination of response choices describes a health state.	Enrollment up to 12 months postoperatively (18 months if crossover at 3 months from ARM 1 to ARM 2)
Secondary	Lysholm knee score	The Lysholm score is comprised of eight domains including limp, locking, pain, stair climbing, and use of supports, instability, swelling, and squatting, for a combined score ranging from 0-100.	Enrollment up to 12 months postoperatively (18 months if crossover at 3 months from ARM 1 to ARM 2)