Time-dependent Functional Results Following HTO. Closing Wedge vs Opening Wedge Technique.

Study Overview
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Brief Summary
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Prospective randomized study. Compare two techniques for high tibial osteotomy (HTO) for treatment of medial knee osteoarthritis. Opening wedge osteotomy using Puddu plate vs Closing wedge osteotomy using cramp fixation. We will compare functional results and patient satisfaction with repetitive evaluations from preoperatively to 2 years postoperatively.

Detailed Description
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Determination of the time course of patient-relevant functional outcome and the time course of Range of Motion (ROM) following HTO. Comparison of the Opening wedge and Closing wedge methods. Time-dependent improvement in functional outcome following High tibial Osteotomy. Medial opening wedge vs Lateral closing wedge. A two-year prospective randomized study involving 70 patients. In a prospective randomized study, we plan to include 70 patients aged 30-60 years operated with valgus high tibial osteotomy. 2 groups: 35 opening wedge, and 35 closing wedge osteotomies. Data are collected by independent investigators (physiotherapists) preoperatively and at 3 months, 6 months, 1 year, and 2 years postoperatively. Knee injury and Osteoarthritis Outcome Score (KOOS) and ROM are determined at all follow-ups.

Official Title
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Time-dependent Functional Results Following HTO. Closing Wedge vs Opening Wedge Technique.

Conditions
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Osteoarthritis

Intervention / Treatment
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* Other: High tibial osteotomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medial osteoarthritis in the knee (x-ray and arthroscopy) Pain in medial compartment of the knee Correction angle of 5 degrees or more Exclusion Criteria: Former or active infection in the knee Rheumatoid arthritis or other similar disease Cancer Neurological disease Kidney disease or metabolic disease

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 60 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 |
| --- | --- |
| Active Comparator: Opening wedge HTO<br>Opening wedge high tibial osteotomy using Puddu plate | Other: High tibial osteotomy<br> <br> |
| Active Comparator: Closing wedge HTO<br>Closing wedge high tibial osteotomy using cramp fixation | Other: High tibial osteotomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kne injury and Osteoarthritis Outcome Score (KOOS) | The change in KOOS score are followed at several time points the first 2 years. Patients will be evaluated with KOOS, 3 months, 6 months, 1 year and 2 years postoperatively. | 2 years postoperataively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Range of motion (ROM) | The change in ROM are followed at several time points the first 2 years. ROM will be measured 3 months, 6 months, 1 year and 2 years postoperatively. | 2 years postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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osteoarthritis, osteotomy, closing, opening, wedge, kne, tibia