A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Trial Comparing High Tibial Osteotomy Plus Non-Surgical Treatment and Non-Surgical Treatment Alone

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: Medial Opening Wedge High Tibial Osteotomy (HTO)
* Other: Non-Surgical Treatment Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Is the subject either: 25-55 years old? Older than 55 but still active (ex. physical labour, regular recreational activities)? 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: Has this subject had a previous HTO or joint replacement in either limb? Is this subject likely to undergo bilateral HTO within the 2 year follow up period? Does this subject have an unstable knee or ligament? Does this subject have inflammatory or infectious arthritis of the knee? Radiographic disease too advanced for HTO (ie. diffuse lateral compartment, patellofemoral joint OA and/or severe enough disease to suggest that joint replacement is the better surgical option) and/or Kellgren and Lawrence grade 4. The subject's disease is not advanced enough (symptomatically or radiographically) to warrant HTO. Does this subject have a major medical illness with life expectancy <2 years or with an unacceptably high operative risk? Does this subject have a major neurological deficit that would affect gait? Is this subject possibly pregnant or planning pregnancy? Is this subject unable to read English? Does this subject have a psychiatric illness that limits informed consent? Is the subject unlikely to comply with study protocol?

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-Surgical Treatment plus HTO<br>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. | Procedure: Medial Opening Wedge High Tibial Osteotomy (HTO)<br>* A lower limb realignment surgery to redistribute load away from the most affected portion of the knee.<br>Other: Non-Surgical Treatment Program<br>* A 12-week optimized non-surgical treatment program consisting of medication, physiotherapy and nutritional seminars.<br>|
| Active Comparator: Non-Surgical Treatment<br>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. | Other: Non-Surgical Treatment Program<br>* A 12-week optimized non-surgical treatment program consisting of medication, physiotherapy and nutritional seminars.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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knee osteoarthritis, high tibial osteotomy, gait analysis, muscular strength, body composition, magnetic resonance imaging, biological markers