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Multimodal Imaging of Subchondral Bone in Knee Osteoarthritis : Predictive Model

Not Applicable
Active, not recruiting
Conditions
Arthritis
Knee Osteoarthritis
Joint Disease
Musculoskeletal 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
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
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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
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
Imagingmultimodal imagingmultimodal imaging and clinical assessment
Primary Outcome Measures
NameTimeMethod
Proportion of patients who have one-point increase in the quality score of OARSI3 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 mm3 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
NameTimeMethod
Change From Baseline in quality of life Scores3 years

Short Form 36

Number of particpants who will have evolution of strucutral lesion score3 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 Scale3 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 space3 years

Evolution of medial femoral-tibial joint space

Trial Locations

Locations (2)

CHR Orléans

🇫🇷

Orléans, France

Chu Brabois

🇫🇷

Nancy, France

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