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

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: Active, not recruiting
• Conditions: Arthritis; Knee Osteoarthritis; Musculoskeletal Disease; Joint Disease
• Intervention / Treatment: Diagnostic test: multimodal imaging

• Study Type: Interventional
• Enrollment (Actual): 167
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aurélie Despujols; Phone Number: 33 2 38 74 40 71; Email: aurelie.despujols@chr-orleans.fr
• Study Contact Backup: Name: Elodie TATSI TOTOUOM; Phone Number: 33 2 38 74 40 86; Email: elodie.tatsi-totouom@chr-orleans.fr

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Imaging; multimodal imaging and clinical assessment	Diagnostic test: multimodal imaging; Other Names: clinical assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	3 years
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.	3 years
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).	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who have evolution of medial femoral tibial joint space	Evolution of medial femoral-tibial joint space	3 years
Number of particpants who will have evolution of strucutral lesion score	Evolution structural lesion score is OARSI (OsteoArthritis Research Society International score)	3 years
Evolution of algo-functional scores (OAKHQOL)	OAKHQOL (OsteoArthritis of Knee and Hip Quality Of Life) scores	3 years
Evolution of algo-functional scores (WOMAC)	WOMAC (McMaster Western Ontario questionnaire ) scores	3 years
Change From Baseline in quality of life Scores	Short Form 36	3 years
Change From Baseline in Pain Scores on the Visual Analog Scale	Pain visual analogical score	3 years

Collaborators and Investigators

• Sponsor: Centre Hospitalier Régional d'Orléans
• Collaborators: University of Nancy
• Investigators: Principal Investigator: Eric LESPESSAILLES, Dr, CHR Orléans

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 29, 2016
• Primary Completion (Estimated): November 28, 2024
• Study Completion (Estimated): November 28, 2024

Study Registration Dates

• First Submitted: July 4, 2017
• First Submitted That Met QC Criteria: September 22, 2017
• First Posted (Actual): September 27, 2017

Study Record Updates

• Last Update Posted (Estimated): February 29, 2024
• Last Update Submitted That Met QC Criteria: February 28, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: knee osteoarthritis; fractal analysis; trabecular bone texture; subchondral bone; Medical Resonnance Imaging
• Additional Relevant MeSH Terms: Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Joint Diseases; Musculoskeletal Diseases
• Other Study ID 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