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).
MRI-verified isolated tibial medial meniscus root tear
Subject must be 18 years of age or older
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).
Parallel
Non-Operative Pain Management
Other interventionThe 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
Procedure/SurgeryThe 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)
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.
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.
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).
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.
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.
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Rush University Medical Center
Lead sponsor
International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine
Collaborator
