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Knee OsteoarthritisMOSARTNCT03294408

Multimodal Imaging of Subchondral Bone in Knee Osteoarthritis : Predictive Model

A study testing multimodal imaging in people with Knee Osteoarthritis and Joint Disease, run by Centre Hospitalier Régional d'Orléans at 2 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 45 to 80 years
Conditions the study is for
Knee Osteoarthritis, Joint Disease, Arthritis
What is being tested?
multimodal imaging
Could I receive a placebo?
No, everyone receives an active treatment
How many people
167 participants
Where
2 sitesFrance
Study dates
29 Nov 2016to 19 Jun 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Patello-femoral degenerative osteoarthritis isolated.
  • Incapacitated to consider the position in schuss for the realization of the radiography.
  • Valgus > in 5 °
  • Secondary degenerative osteoarthritis

Trial locations and contacts

2 sites in 1 country.

France2 sites

  • Chu Brabois

    Nancy, 54511

  • CHR Orléans

    Orléans, 45067

Other trials in France

About this study

Official title: 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.

Being tested
multimodal imaging
Keywords
fractal analysis, trabecular bone texture, knee osteoarthritis, subchondral bone, Medical Resonnance Imaging
Medical subject headings
Osteoarthritis, Knee, Joint Diseases, Arthritis, Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • multimodal imagingDiagnostic test

    Also called clinical assessment

Study groups in NCT03294408
Study groupRoleWhat they receive
ImagingOthermultimodal imaging and clinical assessment
Receives: Diagnostic Test: multimodal imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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).

    Measured: 3 years

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

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

    Measured: 3 years

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

    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).

    Measured: 3 years

Secondary outcomes (6)

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

    Evolution of medial femoral-tibial joint space

    Measured: 3 years

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

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

    Measured: 3 years

  3. Evolution of algo-functional scores (OAKHQOL)

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

    Measured: 3 years

  4. Evolution of algo-functional scores (WOMAC)

    WOMAC (McMaster Western Ontario questionnaire ) scores

    Measured: 3 years

  5. Change From Baseline in quality of life Scores

    Short Form 36

    Measured: 3 years

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

    Pain visual analogical score

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Sep 2017
  2. Study start29 Nov 2016
  3. Primary completion19 Jun 2023
  4. Study completion19 Jun 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
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)
Enrolment
167 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03294408
Sponsor's protocol ID
CHRO-2016-01
Other IDs
2016-A00552-49
Acronym
MOSART
Status last verified
Nov 2025
First submitted
4 Jul 2017
Last updated
28 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Janvier T, Jennane R, Valery A, Harrar K, Delplanque M, Lelong C, Loeuille D, Toumi H, Lespessailles E. Subchondral tibial bone texture analysis predicts knee osteoarthritis progression: data from the Osteoarthritis Initiative: Tibial bone texture & knee OA progression. Osteoarthritis Cartilage. 2017 Feb;25(2):259-266. doi: 10.1016/j.joca.2016.10.005. Epub 2016 Oct 11.

    PubMed 27742531

  • Arden N, Richette P, Cooper C, Bruyere O, Abadie E, Branco J, Brandi ML, Berenbaum F, Clerc C, Dennison E, Devogelaer JP, Hochberg M, D'Hooghe P, Herrero-Beaumont G, Kanis JA, Laslop A, Leblanc V, Maggi S, Mautone G, Pelletier JP, Petit-Dop F, Reiter-Niesert S, Rizzoli R, Rovati L, Tajana Messi E, Tsouderos Y, Martel-Pelletier J, Reginster JY. Can We Identify Patients with High Risk of Osteoarthritis Progression Who Will Respond to Treatment? A Focus on Biomarkers and Frailty. Drugs Aging. 2015 Jul;32(7):525-35. doi: 10.1007/s40266-015-0276-7.

    PubMed 26085027

  • Woloszynski T, Podsiadlo P, Stachowiak GW, Kurzynski M, Lohmander LS, Englund M. Prediction of progression of radiographic knee osteoarthritis using tibial trabecular bone texture. Arthritis Rheum. 2012 Mar;64(3):688-95. doi: 10.1002/art.33410.

    PubMed 21989629

  • Guermazi A, Roemer FW, Felson DT, Brandt KD. Motion for debate: osteoarthritis clinical trials have not identified efficacious therapies because traditional imaging outcome measures are inadequate. Arthritis Rheum. 2013 Nov;65(11):2748-58. doi: 10.1002/art.38086. No abstract available.

    PubMed 23861096

  • Kraus VB, Feng S, Wang S, White S, Ainslie M, Brett A, Holmes A, Charles HC. Trabecular morphometry by fractal signature analysis is a novel marker of osteoarthritis progression. Arthritis Rheum. 2009 Dec;60(12):3711-22. doi: 10.1002/art.25012.

    PubMed 19950282

Questions about this trial

What is this clinical trial studying?

A study testing multimodal imaging in people with Knee Osteoarthritis and Joint Disease, run by Centre Hospitalier Régional d'Orléans at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who have one-point increase in the quality score of OARSI (time frame: 3 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03294408, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.

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