High Tibial Osteotomy With/Without Arthroscopy.

Study Overview
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Brief Summary
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This study will compare Hight Tibial Osteotomy with or without arthroscopically repair intra-articular knee lesions in patients with early stages of Osteoarthritis.The purpose of this study is evaluate if addition of arthroscopy to HTO provides better clinical, radiological and laboratory outcomes.

Detailed Description
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Intraarticular knee lesions are often in patients with early stages of osteoarthritis. The most frequent findings are degenerative meniscus/meniscal tears and cartilage degeneration. Degenerative meniscal lesions or meniscal tears are often incidental findings without any complains from patients. In the current literature there is no evidence for good clinical outcomes after arthroscopically treatment degenerative meniscus. Cartilage injuries are common in osteoarthritic knee and depending on grading of chondromalacia are usually treated by microfractures. By this time the choice of performed surgery depends on surgeons personal assessment. The investigators believe that concomitant intraarticular procedures added to HTO will provide better clinical outcomes.

Official Title
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Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes of Hight Tibial Osteotomy With or Without Concomitant Arthroscopic Treatment of Knee Intraarticular Lesions.

Conditions
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Osteoarthritis, Knee, Meniscus; Degeneration

Intervention / Treatment
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* Procedure: HTO
* Procedure: Arthroscopy treatment
* Procedure: Micro fractures


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Knee medial compartment or patellofemoral osteoarthritis in medical interview and physical examination Intraarticular lesions in MRI Confirmation of cartilage degeneration/damage and knee malalignment in radiological tests Exclusion Criteria: no informed consent to participate in the study age under 18 years or above 65 multilligament injury or single plane knee instability another musculoskeletal disorders in lower limb lower limb deformity requiring axis correction below 4o or above 12.5o • joints inflammatory diseases ASA score > II

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: High Tibial Osteotomy and arthroscopy<br>High Tibial Osteotomy with arthroscopically treatment of intraarticular lesions. | Procedure: HTO<br>* Hight Tibial Osteotomy<br>Procedure: Arthroscopy treatment<br>* Arthroscopy treatment<br>|
| Sham Comparator: High Tibial Osteotomy<br>Descending High Tibial Osteotomy with arthroscopy without treatment of intraarticular lesions. | Procedure: HTO<br>* Hight Tibial Osteotomy<br>|
| Active Comparator: High Tibial Osteotomy, arthroscopy and microfractures<br>High Tibial Osteotomy with arthroscopically treatment of intraarticular lesions and microfracture. | Procedure: HTO<br>* Hight Tibial Osteotomy<br>Procedure: Arthroscopy treatment<br>* Arthroscopy treatment<br>Procedure: Micro fractures<br>* Micro fractures<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS | Knee Injury and Osteoarthritis Outcome Score | 12 months | 
| KOOS | Knee Injury and Osteoarthritis Outcome Score | 24 months | 
| IKDC | International Knee Documentation Committee - Subjective Knee Evaluation Form | 12 months | 
| IKDC | International Knee Documentation Committee - Subjective Knee Evaluation Form | 24 months | 
| VAS | Visual Analog Scale | 12 months | 
| VAS | Visual Analog Scale | 24 months | 
| Blood test | no inflammatory reaction - CRP, Il-6, CTx | 2 day | 
| Blood test | no inflammatory reaction - CRP, Il-6, CTx | 6 weeks | 
| Blood test | no inflammatory reaction - CRP, Il-6, CTx | 12 weeks, | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kinematic MRI with [chondrogram] | Meniscus healing, cartilage quality | 2 day, | 
| Kinematic MRI with [chondrogram] | Meniscus healing, cartilage quality | 24 months | 
| X-ray - Baldini projection | Patellofemoral joint measurements | 2 day | 
| X-ray - Baldini projection | Patellofemoral joint measurements | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HTO, Degenerative Meniscus, Osteoarthritis, Microfracture