Clinical trial NCT05985772: Operative vs Non-operative Management of Posterior-medial Meniscal Root Tears: A Randomized Multicenter Trial (RCT)
Official title: Operative vs Non-operative Management of Posterior-medial Meniscal Root Tears: A Randomized Multicenter Trial (RCT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Meniscus Tear, Tibial
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
Collaborators: name: International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine (ISAKOS)
First posted: 2023-08-14
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model 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.
Primary purpose: OTHER

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).

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Visual analogue scale (VAS) for pain
timeFrame: Enrollment up to 12 months postoperatively (18 months if crossover at 3 months from ARM 1 to ARM 2)
Secondary outcomes:
measure: Western Ontario Meniscal Evaluation Tool (WOMET)
timeFrame: Enrollment up to 12 months postoperatively (18 months if crossover at 3 months from ARM 1 to ARM 2)
measure: Knee Osteoarthritis and Outcomes Score (KOOS)
timeFrame: Enrollment up to 12 months postoperatively (18 months if crossover at 3 months from ARM 1 to ARM 2)
measure: European Quality of Life Scale (Euro-QoL)
timeFrame: Enrollment up to 12 months postoperatively (18 months if crossover at 3 months from ARM 1 to ARM 2)
measure: Lysholm knee score
timeFrame: Enrollment up to 12 months postoperatively (18 months if crossover at 3 months from ARM 1 to ARM 2)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
affiliation: Rush University Medical Center Associate Professor and Surgeon
name: Jorge Chahla, MD
role: PRINCIPAL_INVESTIGATOR
References: