Randomized Control Trial on Postoperative Weight Bearing After High Tibial Osteotomy (HTO)

Study Overview
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Brief Summary
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The study analyzes the consequences of weight bearing after an HTO in a population of young patient with medial osteoarthritis (immediate weight bearing versus two month weight bearing). The two options are usually used so the protocol belongs to the intermediate care evaluation category. The IKS (International Knee Society) score at one year follow up is the first outcome. The aim of the study is to highlight that the option early weight bearing (immediately in postoperative) is equal to the option delayed weight bearing.

Official Title
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Prospective Study on Postoperative Weight Bearing After Opening Wedge High Tibial Osteotomy (HTO): Early Weight Bearing Versus Delayed. Open Labelled Randomized Clinical Study

Conditions
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Osteoarthritis, Knee

Intervention / Treatment
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* Procedure: Early weight bearing
* Procedure: Delayed weight bearing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age: 40 to 65 years old patients with medial osteoarthritis of knee of level 1 or 2 from ahlback's classification with High Tibial Osteotomy indication one sided indication well understanding of information note by patient, non-opposition to perform the research Affiliation to a national health insurance program Exclusion Criteria: age < 40 or > 65 years old medial osteoarthritis of knee of level superior to 2 bilatéral indication patient opposition non affiliation to a national health insurance program law protected patients pregnancy and breast feeding

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Early weight bearing: immediate in postoperative | Procedure: Early weight bearing<br>* Weight bearing performed immediately after surgery<br>|
| Experimental: 2<br>Delayed weight bearing: 2 months after surgery | Procedure: Delayed weight bearing<br>* Weight bearing performed 2 months after surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IKS score |  | one year follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IKS score |  | 6 months follow-up | 
| VAS score of pain |  | at D1, D5, D15, M1, M2, M3, M6 and one year follow-up | 
| IKDC (International Knee Documentation Committee) score |  | at M2, M, M6 and one year follow-up | 
| Safety follow-up |  | during the one year follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Osteotomy, Weight bearing, Opening wedge