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Multimodal Imaging of Subchondral Bone in Knee Osteoarthritis : Predictive Model (MOSART)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03294408
Recruitment Status : Recruiting
First Posted : September 27, 2017
Last Update Posted : February 5, 2020
Sponsor:
Collaborator:
University of Nancy
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Joint Disease Arthritis Musculoskeletal Disease Diagnostic Test: multimodal imaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 425 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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)
Primary Purpose: Prevention
Official Title: Capacity of Multimodal Imaging of Subchondral Bone for the Prediction of Structural Evolution in Knee Osteoarthritis
Actual Study Start Date : November 29, 2016
Estimated Primary Completion Date : November 28, 2021
Estimated Study Completion Date : November 28, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Imaging
multimodal imaging and clinical assessment
Diagnostic Test: multimodal imaging
Other Name: clinical assessment




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03294408


Contacts
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Contact: Aurélie DESPUJOLS 33 2 38 74 40 71 aurelie.despujols@chr-orleans.fr
Contact: Elodie TATSI TOTOUOM 33 2 38 74 40 86 elodie.tatsi-totouom@chr-orleans.fr

Locations
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France
Chu Brabois Recruiting
Nancy, France, 54511
Contact: Damien LOEUILLE, Pr    33 3 83 15 36 26    d.loeuille@chru-nancy.fr   
CHR Orléans Recruiting
Orléans, France, 45067
Contact: Eric LESPESSAILLES, Dr    33 2 38 74 42 01    eric.lespessailles@chr-orleans.fr   
Sponsors and Collaborators
Centre Hospitalier Régional d'Orléans
University of Nancy
Investigators
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Principal Investigator: Eric LESPESSAILLES, Dr CHR Orléans
Publications:

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Responsible Party: Centre Hospitalier Régional d'Orléans
ClinicalTrials.gov Identifier: NCT03294408    
Other Study ID Numbers: CHRO-2016-01
2016-A00552-49 ( Registry Identifier: IDRCB )
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: February 5, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Régional d'Orléans:
fractal analysis
trabecular bone texture
knee osteoarthritis
subchondral bone
Medical Resonnance Imaging
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases