The purpose of this study is to compare patients with knee osteoarthritis (OA) receiving optimized non-surgical treatment plus surgical realignment of the tibia, or optimized non-surgical treatment only. We hypothesize that outcomes assessed at 12 and 24 months follow-up will suggest favourable changes in patients undergoing surgical realignment when compared to patients receiving non-surgical treatment only.
This two groups, parallel design randomized controlled trial will compare patients with medial compartment knee OA and varus alignment receiving optimized non-surgical treatment plus High Tibial Osteotomy (HTO) to similar patients receiving optimized non-surgical treatment only. All participants will receive non-surgical treatment that will be individualized to the patient and include medications, physiotherapy and nutritional seminars. The non-surgical treatment will include supervised physiotherapy and nutritional seminars once per week for 12 weeks, will be accompanied and followed by a home program, and follow-up appointments for potential modification every three months for the duration of the study. Participants randomized to surgery will also undergo medial opening wedge HTO after 12 weeks of optimized non-surgical treatment. Both groups will follow the same schedule of clinic visits throughout the 24 month follow-up period. MRI-derived measures of articular cartilage morphology, biological markers of articular cartilage degradation and synthesis, gait biomechanics and patient-reported outcomes will be assessed at baseline, 12 and 24 months follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
71
A lower limb realignment surgery to redistribute load away from the most affected portion of the knee.
A 12-week optimized non-surgical treatment program consisting of medication, physiotherapy and nutritional seminars.
Fowler Kennedy Sport Medicine Clinic, Western University
London, Ontario, Canada
MRI articular cartilage morphology
3 Tesla MRI measure of medial tibiofemoral articular cartilage thickness
Time frame: Change from baseline to 24 months post operative
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Patient-reported outcome measure. 5 subdomains: pain, symptoms, activities of daily living, sport and recreation, quality of life
Time frame: Change from baseline to 24 months post operative
Western Ontario Meniscal Evaluation Tool (WOMET)
Patient-reported outcome measure. Assesses health-related quality of life (HRQoL) in patients with meniscal tears. 3 dimensions: physical symptoms, sports/recreation/work/lifestyle, emotions
Time frame: Change from baseline to 24 months post operative
Biological Markers of Disease Progression
Synovial fluid, serum and urine biological markers
Time frame: Baseline, 12 and 24 months post operative
Numeric Rating Scale for Pain
Patient-reported outcome measure. Assesses patient's pain. 0 (no pain) - 10 (worst possible pain)
Time frame: Baseline, 12 and 24 months post operative
Gait Biomechanics
Knee frontal, sagittal and transverse plane kinematics and kinetics tested during level walking in a motion analysis laboratory. The measure of most interest is the peak external knee adduction moment during stance phase of walking.
Time frame: Baseline, 12 and 24 months post operative
Isometric Strength Testing
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Isometric quadriceps and hamstrings strength tested using an isokinetic dynamometer.
Time frame: Baseline, 12 and 24 months post operative
Intermittent and Constant Osteoarthritis Pain Index (ICOAP)
Patient-reported outcome measure. Assesses pain in individuals with hip or knee osteoarthritis taking into account both constant and intermittent pain. 3 domains: intermittent pain, constant pain, total pain
Time frame: Change from baseline to 24 months post operative
Short-Form 12 (SF12)
Patient-reported outcome measure. Self-reported outcome measure assessing the impact of health on an individual's everyday life
Time frame: Change from baseline to 24 months post operative
Western Ontario and McMaster Universities Arthritis Index (WOMAC)
Patient-reported outcome measure. 3 sub domains: pain, symptoms, function
Time frame: Change from baseline to 24 months post operative