Multimodal Imaging of Subchondral Bone in Knee Osteoarthritis : Predictive Model

Study Overview
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Brief Summary
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Predictive factors of osteoarthritis progression are not yet well understood. However, a growing role attaches importance to the subchondral bone. The aim of the present project is to determine predictive factors of progression of osteoarthritis at the knee by a multimodal characterization of subchondral bone by Medical Resonnance Imaging, direct high resolution digitization radiographs and bone texture analysis. At the end of the project, an innovative imaging device, combining semi-automatic softwares for texture analysis, control detection and image registration would be supplied. This will enable on the one hand a more accurate and reproducible way to measure the joint space width of the affected compartment and on the other hand, an assistance to better detect patients at risk of progression of their knee osteoarthritis. Identifying These progressors patients might permit their selection in clinical trials at baseline adapted to their severe disease, using for example biologic treatments targeting knee osteoarthritis. The main objective of this study is to analyze the predictive capacities of bone texture parameters measured on the high-resolution radiography of the knee on the structural evolution of the knee osteoarthritis at 3 years.

Official Title
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Capacity of Multimodal Imaging of Subchondral Bone for the Prediction of Structural Evolution in Knee Osteoarthritis

Conditions
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Knee Osteoarthritis, Joint Disease, Arthritis, Musculoskeletal Disease

Intervention / Treatment
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* Diagnostic Test: multimodal imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: knee osteoarthritis according to the criteria of knee osteoarthritis of American College of Rheumatology. Having felt a painful push in the last 6 months. Visual Analogic Scale pain > 4 on a 0 to 10 scale. having a Radiographic score of OARSI (Osteoarthritis Research Society International Score) from 2 to 3 whether it is for the presence of a joint space narrowing or the presence of an osteophyte Exclusion Criteria: Patello-femoral degenerative osteoarthritis isolated. Incapacitated to consider the position in schuss for the realization of the radiography. Valgus > in 5 ° Secondary degenerative osteoarthritis

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 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: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: Interventional study among patients suffering from knee osteoarthritis for at least six months. All the patients will benefit from a multimodal imaging and clinical assessment.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Imaging<br>multimodal imaging and clinical assessment | Diagnostic Test: multimodal imaging<br> <br> * Other names: clinical assessment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who have one-point increase in the quality score of OARSI | Patients who over the 3-year follow-up period will have a one-point increase in the quality score of OARSI compared to the initial pinch score (Altman RD et al, Osteoarthritis and Cartilage 1995). | 3 years | 
| Proportion of patients whose joint space reduction is greater than the smallest reliable detectable difference. | Patients whose joint space reduction is greater than the smallest reliable detectable difference. | 3 years | 
| Proportion of patients who have a decrease in joint space of 0.5 mm | Patients who have a decrease in joint space of 0.5 mm or more over the 3-year period (Cooper C et al, CMRO 2012). | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who have evolution of medial femoral tibial joint space | Evolution of medial femoral-tibial joint space | 3 years | 
| Number of particpants who will have evolution of strucutral lesion score | Evolution structural lesion score is OARSI (OsteoArthritis Research Society International score) | 3 years | 
| Evolution of algo-functional scores (OAKHQOL) | OAKHQOL (OsteoArthritis of Knee and Hip Quality Of Life) scores | 3 years | 
| Evolution of algo-functional scores (WOMAC) | WOMAC (McMaster Western Ontario questionnaire ) scores | 3 years | 
| Change From Baseline in quality of life Scores | Short Form 36 | 3 years | 
| Change From Baseline in Pain Scores on the Visual Analog Scale | Pain visual analogical score | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fractal analysis, trabecular bone texture, knee osteoarthritis, subchondral bone, Medical Resonnance Imaging