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| ID | Type | Description | Link |
|---|---|---|---|
| MOP-133489 | Other Grant/Funding Number | CIHR |
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| Name | Class |
|---|---|
| The Arthritis Society, Canada | OTHER |
| Canadian Institutes of Health Research (CIHR) | OTHER_GOV |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-Surgical Treatment plus HTO | Experimental | The optimized non-surgical treatment program consists of medications, physiotherapy and nutritional seminars. The 12-week program will include an assessment by a primary care physician, physiotherapist and orthopaedic surgeon, one supervised physiotherapy session per week, one body recomposition session per week, and a home program. After the 12-week program is completed, patients randomized to this group will undergo a medial opening wedge high tibial osteotomy (HTO). They will continue with their home program and will be followed up for 2 years after baseline. |
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| Non-Surgical Treatment | Active Comparator | The optimized non-surgical treatment program consists of medications, physiotherapy and nutritional seminars. The 12-week program will include an assessment by a primary care physician, physiotherapist and orthopaedic surgeon, one supervised physiotherapy session per week, one body recomposition session per week, and a home program. After the 12-week program is completed, patients randomized to this group will continue with their home program and will be followed up for 2 years after baseline. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medial Opening Wedge High Tibial Osteotomy (HTO) | Procedure | A lower limb realignment surgery to redistribute load away from the most affected portion of the knee. |
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| Measure | Description | Time Frame |
|---|---|---|
| MRI articular cartilage morphology | 3 Tesla MRI measure of medial tibiofemoral articular cartilage thickness | Change from baseline to 24 months post operative |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change from baseline to 24 months post operative |
| Western Ontario Meniscal Evaluation Tool (WOMET) |
| Measure | Description | Time Frame |
|---|---|---|
| Cost-effectiveness questionnaires | Collection of accumulated direct and indirect costs related to the intervention incurred over the study period as reported by the patient. | Baseline and every 3 months from baseline up to 24 months post operative |
Inclusion Criteria:
Is the subject either:
Does this subject present with varus alignment? (Based on hip to ankle x-rays).
Does this subject have clinical Knee OA? (MAA <-2° on full limb standing AP) according to the Altman classification primarily involving the medial compartment of the knee?
Patient is a good candidate for high tibial osteotomy and will be receiving a PEEK plate, or if receiving an alternate plate, agrees to have the plate removed prior to 1 year postoperative.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Trevor B Birmingham, PT, PhD | Western University | Principal Investigator |
| J R Giffin, MD | Western University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fowler Kennedy Sport Medicine Clinic, Western University | London | Ontario | N6A 3K7 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40720836 | Derived | Birmingham TB, Primeau CA, Moyer RF, Bryant DM, Ma J, Leitch KM, Wirth W, Degen R, Getgood AM, Litchfield RB, Willits KR, Eckstein F, Giffin JR. High Tibial Osteotomy for Medial Compartment Knee Osteoarthritis : A Randomized Trial With Parallel Preference Arm. Ann Intern Med. 2025 Sep;178(9):1238-1248. doi: 10.7326/ANNALS-25-00920. Epub 2025 Jul 29. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 30, 2026 | |
| Reset | Feb 17, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 30, 2026 | Feb 17, 2026 |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Non-Surgical Treatment Program | Other | A 12-week optimized non-surgical treatment program consisting of medication, physiotherapy and nutritional seminars. |
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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 |
| Change from baseline to 24 months post operative |
| Biological Markers of Disease Progression | Synovial fluid, serum and urine biological markers | 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) | 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. | Baseline, 12 and 24 months post operative |
| Isometric Strength Testing | Isometric quadriceps and hamstrings strength tested using an isokinetic dynamometer. | 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 | 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 | 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 | Change from baseline to 24 months post operative |
| D012216 |
| Rheumatic Diseases |