High Tibial Osteotomy With/Without Fulkerson Osteotomy in Knee OA

Study Overview
=================
Brief Summary
-----------------
This study will compare Hight Tibial Osteotomy with or without Fulkerson Osteotomy performed on patients with early stages of Osteoarthritis with patellofemoral joint disorders. The purpose of this study is evaluate which type of osteotomy provides better clinical, radiological and laboratory outcomes.

Detailed Description
-----------------
Progression of knee cartilage degenerative changes leads to necessary total knee arthroplasty in future, which is the most popular procedure for treating OA. HTO applied at early stages of osteoarthritis allow slow down cartilage degeneration process, but the choice of performed surgery depends on surgeons personal assessment. Patellofemoral Pain Syndrome often occurs with knee arthritis. Antero-medialisation of tibial tubercle is frequent procedures for patella maltracking. So far, both, HTO and Fulkerson osteotomy was performed separately, even if patient have symptoms from patellofemoral joint and OA. The investigators believe that simultaneously surgery of HTO and fulkerson Osteotomy provides better outcomes and significantly slow down knee degeneration.

Official Title
-----------------
Prospective, Randomized, Double Blinded Trial Comparing Clinical, Radiological and Laboratory Outcomes of Hight Tibial Osteotomy With or Without Concomitant Fulkerson Osteotomy

Conditions
-----------------
Osteoarthritis, Knee, Patellofemoral Disorder

Intervention / Treatment
-----------------
* Procedure: High Tibial Osteotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Knee medial compartment or patellofemoral osteoarthritis in medical interview and physical examination 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 multi ligament 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
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

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: HTO and Fulkerson<br>High Tibial Osteotomy with Antero-medialisation of Tibial Tubercle | Procedure: High Tibial Osteotomy<br>* Surgery procedure - High Tibial Osteotomy<br>|
| Sham Comparator: HTO<br>Descending Hight Tibial Osteotomy | Procedure: High Tibial Osteotomy<br>* Surgery procedure - High Tibial Osteotomy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomechanics MRI | Patellofemoral Joints Biomechanics improvement measured | 1 year | 
| Biomechanics MRI | Patellofemoral Joints Biomechanics improvement measured | 2 years | 
| Biomechanics X-ray | Patellofemoral Joints Biomechanics improvement measured | 12 weeks | 
| Biomechanics X-ray | Patellofemoral Joints Biomechanics improvement measured | 6 months | 
| Biomechanics X-ray | Patellofemoral Joints Biomechanics improvement measured | 12 months | 
| Biomechanics X-ray | Patellofemoral Joints Biomechanics improvement measured | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| KOOS | Knee Injury and Osteoarthritis Outcome Score | 12 weeks | 
| KOOS | Knee Injury and Osteoarthritis Outcome Score | 6 months | 
| KOOS | Knee Injury and Osteoarthritis Outcome Score | 12 months | 
| KOOS | Knee Injury and Osteoarthritis Outcome Score | 24 months | 
| IKDC | International Knee Documentation Committee | 12 weeks | 
| IKDC | International Knee Documentation Committee | 6 months | 
| IKDC | International Knee Documentation Committee | 12 months, | 
| IKDC | International Knee Documentation Committee | 24 months | 
| Tegner Lysholm | Tegner Lysholm Knee Scoring Scale | 12 weeks, | 
| Tegner Lysholm | Tegner Lysholm Knee Scoring Scale | 6 months | 
| Tegner Lysholm | Tegner Lysholm Knee Scoring Scale | 12 months | 
| Tegner Lysholm | Tegner Lysholm Knee Scoring Scale | 24 months | 
| SF-36 | The Short Form (36) Health Survey | 12 weeks | 
| SF-36 | The Short Form (36) Health Survey | 6 months | 
| SF-36 | The Short Form (36) Health Survey | 12 months | 
| SF-36 | The Short Form (36) Health Survey | 24 months | 
| VAS | Pain Visual Analog Scale | 12 week | 
| VAS | Pain Visual Analog Scale | 6 months | 
| VAS | Pain Visual Analog Scale | 12 months | 
| VAS | Pain Visual Analog Scale | 24 months | 
| Blood test | CRP, IL-6, CTx | 2nd day | 
| Blood test | CRP, IL-6, CTx | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HTO, Fulkerson, Osteoarthritis