CClinicalTrials.gg
CompletedNCT03294408MOSARTUpdated Nov 28, 2025

Multimodal Imaging of Subchondral Bone in Knee Osteoarthritis : Predictive Model

An interventional study of multimodal imaging in Knee Osteoarthritis, Joint Disease and Arthritis, sponsored by Centre Hospitalier Régional d'Orléans. Completed at 2 sites in France. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-11-28.

Sponsored by Centre Hospitalier Régional d'Orléans · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
167
Allocation
Not applicable
Ages
45 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Knee Osteoarthritis
  • Joint Disease
  • Arthritis
  • Musculoskeletal Disease

Keywords

  • fractal analysis
  • trabecular bone texture
  • knee osteoarthritis
  • subchondral bone
  • Medical Resonnance Imaging
03

Who can participate

Ages eligible
45 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
167 participants (actual)

Study arms

  • Other
    Imaging

    multimodal imaging and clinical assessment

    Diagnostic Test: multimodal imaging

Interventions

  • Diagnostic testmultimodal imaging

    Also known as: clinical assessment

05

What researchers measure

Primary outcomes

  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).

    Time frame: 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.

    Time frame: 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).

    Time frame: 3 years

Secondary outcomes

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

    Evolution of medial femoral-tibial joint space

    Time frame: 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)

    Time frame: 3 years

  3. Evolution of algo-functional scores (OAKHQOL)

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

    Time frame: 3 years

  4. Evolution of algo-functional scores (WOMAC)

    WOMAC (McMaster Western Ontario questionnaire ) scores

    Time frame: 3 years

  5. Change From Baseline in quality of life Scores

    Short Form 36

    Time frame: 3 years

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

    Pain visual analogical score

    Time frame: 3 years

06

Study locations

2 sites
  • Chu Brabois
    Nancy, 54511, France
  • CHR Orléans
    Orléans, 45067, France
07

References and documents

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 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03294408
Lead sponsor
Centre Hospitalier Régional d'Orléans
Collaborators
University of Nancy
Responsible party
Sponsor
First posted
Sep 27, 2017
Start date
Nov 29, 2016
Primary completion
Jun 19, 2023
Completion
Jun 19, 2023
Last update
Nov 28, 2025

Study contacts

Eric LESPESSAILLES, Dr
principal investigator · CHR Orléans

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion