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Completed

NCT Number: NCT03294408

Multimodal Imaging of Subchondral Bone in Knee Osteoarthritis : Predictive Model

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.

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Key information

Age range

45 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Brabois, Nancy, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multimodal imaging

Diagnostic Test

Other names: clinical assessment

Primary outcomes

  1. Proportion of patients who have one-point increase in the quality score of OARSI

    Time frame: 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).

  2. Proportion of patients whose joint space reduction is greater than the smallest reliable detectable difference.

    Time frame: 3 years

    Patients whose joint space reduction is greater than the smallest reliable detectable difference.

  3. Proportion of patients who have a decrease in joint space of 0.5 mm

    Time frame: 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 outcomes

  1. Proportion of patients who have evolution of medial femoral tibial joint space

    Time frame: 3 years

    Evolution of medial femoral-tibial joint space

  2. Number of particpants who will have evolution of strucutral lesion score

    Time frame: 3 years

    Evolution structural lesion score is OARSI (OsteoArthritis Research Society International score)

  3. Evolution of algo-functional scores (OAKHQOL)

    Time frame: 3 years

    OAKHQOL (OsteoArthritis of Knee and Hip Quality Of Life) scores

  4. Evolution of algo-functional scores (WOMAC)

    Time frame: 3 years

    WOMAC (McMaster Western Ontario questionnaire ) scores

  5. Change From Baseline in quality of life Scores

    Time frame: 3 years

    Short Form 36

  6. Change From Baseline in Pain Scores on the Visual Analog Scale

    Time frame: 3 years

    Pain visual analogical score

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional d'Orléans

Other

Collaborators

  • University of Nancy

Registry information

Official study title

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

Acronym: MOSART

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Sep 27, 2017
Registry last updated
Nov 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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