Multimodal Imaging of Subchondral Bone in Knee Osteoarthritis : Predictive Model
- Conditions
- ArthritisKnee OsteoarthritisJoint DiseaseMusculoskeletal Disease
- Interventions
- Diagnostic Test: multimodal imaging
- Registration Number
- NCT03294408
- Lead Sponsor
- Centre Hospitalier Régional d'Orléans
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 167
- 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
- Patello-femoral degenerative osteoarthritis isolated.
- Incapacitated to consider the position in schuss for the realization of the radiography.
- Valgus > in 5 °
- Secondary degenerative osteoarthritis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Imaging multimodal imaging multimodal imaging and clinical assessment
- Primary Outcome Measures
Name Time Method Proportion of patients who have one-point increase in the quality score of OARSI 3 years 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).
Proportion of patients whose joint space reduction is greater than the smallest reliable detectable difference. 3 years Patients whose joint space reduction is greater than the smallest reliable detectable difference.
Proportion of patients who have a decrease in joint space of 0.5 mm 3 years 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).
- Secondary Outcome Measures
Name Time Method Change From Baseline in quality of life Scores 3 years Short Form 36
Number of particpants who will have evolution of strucutral lesion score 3 years Evolution structural lesion score is OARSI (OsteoArthritis Research Society International score)
Evolution of algo-functional scores (OAKHQOL) 3 years OAKHQOL (OsteoArthritis of Knee and Hip Quality Of Life) scores
Change From Baseline in Pain Scores on the Visual Analog Scale 3 years Pain visual analogical score
Evolution of algo-functional scores (WOMAC) 3 years WOMAC (McMaster Western Ontario questionnaire ) scores
Proportion of patients who have evolution of medial femoral tibial joint space 3 years Evolution of medial femoral-tibial joint space
Trial Locations
- Locations (2)
CHR Orléans
🇫🇷Orléans, France
Chu Brabois
🇫🇷Nancy, France