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

November 26, 2025 updated by: Centre Hospitalier Régional d'Orléans

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
167

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Nancy, France, 54511
        • Chu Brabois
      • Orléans, France, 45067
        • CHR Orléans

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Imaging
multimodal imaging and clinical assessment
Diagnostic test: multimodal imaging
Other Names:
  • clinical assessment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
3 years
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 years
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).
3 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of patients who have evolution of medial femoral tibial joint space
Time Frame: 3 years
Evolution of medial femoral-tibial joint space
3 years
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 years
Evolution of algo-functional scores (OAKHQOL)
Time Frame: 3 years
OAKHQOL (OsteoArthritis of Knee and Hip Quality Of Life) scores
3 years
Evolution of algo-functional scores (WOMAC)
Time Frame: 3 years
WOMAC (McMaster Western Ontario questionnaire ) scores
3 years
Change From Baseline in quality of life Scores
Time Frame: 3 years
Short Form 36
3 years
Change From Baseline in Pain Scores on the Visual Analog Scale
Time Frame: 3 years
Pain visual analogical score
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Régional d'Orléans

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Nancy

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eric LESPESSAILLES, Dr, CHR Orléans

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 29, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 19, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 19, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 4, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 27, 2017

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHRO-2016-01
  • 2016-A00552-49 (Registry Identifier: IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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