Meniscus Tear, Tibial Clinical Trial
Official title:
Operative vs Non-operative Management of Posterior-medial Meniscal Root Tears: A Randomized Multicenter Trial (RCT)
NCT number | NCT05985772 |
Other study ID # | 19082802 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 20, 2022 |
Est. completion date | March 2026 |
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).
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 3ยบ of varus). - Pregnancy - Subjects < 18 years of age |
Country | Name | City | State |
---|---|---|---|
United States | Rush University Medical Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Rush University Medical Center | International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine (ISAKOS) |
United States,
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) |
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