MOSART: Multimodal Imaging of Subchondral Bone in Knee Osteoarthritis : Predictive Model
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Imaging multimodal imaging and clinical assessment |
Diagnostic Test: multimodal imaging
Other Names:
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Outcome Measures
Primary Outcome Measures
- Proportion of patients who have one-point increase in the quality score of OARSI [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).
- Proportion of patients whose joint space reduction is greater than the smallest reliable detectable difference. [3 years]
Patients whose joint space reduction is greater than the smallest reliable detectable difference.
- Proportion of patients who have a decrease in joint space of 0.5 mm [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).
Secondary Outcome Measures
- Proportion of patients who have evolution of medial femoral tibial joint space [3 years]
Evolution of medial femoral-tibial joint space
- Number of particpants who will have evolution of strucutral lesion score [3 years]
Evolution structural lesion score is OARSI (OsteoArthritis Research Society International score)
- Evolution of algo-functional scores (OAKHQOL) [3 years]
OAKHQOL (OsteoArthritis of Knee and Hip Quality Of Life) scores
- Evolution of algo-functional scores (WOMAC) [3 years]
WOMAC (McMaster Western Ontario questionnaire ) scores
- Change From Baseline in quality of life Scores [3 years]
Short Form 36
- Change From Baseline in Pain Scores on the Visual Analog Scale [3 years]
Pain visual analogical score
Eligibility Criteria
Criteria
Inclusion Criteria:
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knee osteoarthritis according to the criteria of knee osteoarthritis of American College of Rheumatology.
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Having felt a painful push in the last 6 months.
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Visual Analogic Scale pain > 4 on a 0 to 10 scale.
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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:
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Patello-femoral degenerative osteoarthritis isolated.
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Incapacitated to consider the position in schuss for the realization of the radiography.
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Valgus > in 5 °
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Secondary degenerative osteoarthritis
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Chu Brabois | Nancy | France | 54511 | |
| 2 | CHR Orléans | Orléans | France | 45067 |
Sponsors and Collaborators
- Centre Hospitalier Régional d'Orléans
- University of Nancy
Investigators
- Principal Investigator: Eric LESPESSAILLES, Dr, CHR Orléans
Study Documents (Full-Text)
None provided.More Information
Publications
- Arden N, Richette P, Cooper C, Bruyère 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. Review.
- 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.
- 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.
- 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.
- 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.
- CHRO-2016-01
- 2016-A00552-49