Multimodal Imaging of Subchondral Bone in Knee Osteoarthritis : Predictive Model

Knee Osteoarthritis Clinical Trial

— MOSART  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03294408
• Other study ID #: CHRO-2016-01
• Secondary ID: 2016-A00552-49
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 29, 2016
• Est. completion date: November 28, 2024

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Régional d'Orléans
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 167
• Est. completion date: November 28, 2024
• Est. primary completion date: November 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Joint Disease
• Joint Diseases
• Knee Osteoarthritis
• Musculoskeletal Disease
• Musculoskeletal Diseases
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Diagnostic Test:
• multimodal imaging

Locations

Country	Name	City	State
France	Chu Brabois	Nancy
France	CHR Orléans	Orléans

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Régional d'Orléans	University of Nancy

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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