Multimodal Imaging of Subchondral Bone in Knee Osteoarthritis : Predictive Model (MOSART)
Primary Purpose
Knee Osteoarthritis, Joint Disease, Arthritis
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
multimodal imaging
Sponsored by
About this trial
This is an interventional prevention trial for Knee Osteoarthritis focused on measuring fractal analysis, trabecular bone texture, knee osteoarthritis, subchondral bone, Medical Resonnance Imaging
Eligibility Criteria
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
Sites / Locations
- Chu BraboisRecruiting
- CHR OrléansRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Imaging
Arm Description
multimodal imaging and clinical assessment
Outcomes
Primary Outcome Measures
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).
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.
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).
Secondary Outcome Measures
Proportion of patients who have evolution of medial femoral tibial joint space
Evolution of medial femoral-tibial joint space
Number of particpants who will have evolution of strucutral lesion score
Evolution structural lesion score is OARSI (OsteoArthritis Research Society International score)
Evolution of algo-functional scores (OAKHQOL)
OAKHQOL (OsteoArthritis of Knee and Hip Quality Of Life) scores
Evolution of algo-functional scores (WOMAC)
WOMAC (McMaster Western Ontario questionnaire ) scores
Change From Baseline in quality of life Scores
Short Form 36
Change From Baseline in Pain Scores on the Visual Analog Scale
Pain visual analogical score
Full Information
NCT ID
NCT03294408
First Posted
July 4, 2017
Last Updated
February 16, 2023
Sponsor
Centre Hospitalier Régional d'Orléans
Collaborators
University of Nancy
1. Study Identification
Unique Protocol Identification Number
NCT03294408
Brief Title
Multimodal Imaging of Subchondral Bone in Knee Osteoarthritis : Predictive Model
Acronym
MOSART
Official Title
Capacity of Multimodal Imaging of Subchondral Bone for the Prediction of Structural Evolution in Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2016 (Actual)
Primary Completion Date
November 28, 2023 (Anticipated)
Study Completion Date
November 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans
Collaborators
University of Nancy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Joint Disease, Arthritis, Musculoskeletal Disease
Keywords
fractal analysis, trabecular bone texture, knee osteoarthritis, subchondral bone, Medical Resonnance Imaging
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Allocation
N/A
Enrollment
425 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Imaging
Arm Type
Other
Arm Description
multimodal imaging and clinical assessment
Intervention Type
Diagnostic Test
Intervention Name(s)
multimodal imaging
Other Intervention Name(s)
clinical assessment
Primary Outcome Measure Information:
Title
Proportion of patients who have one-point increase in the quality score of OARSI
Description
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
Title
Proportion of patients whose joint space reduction is greater than the smallest reliable detectable difference.
Description
Patients whose joint space reduction is greater than the smallest reliable detectable difference.
Time Frame
3 years
Title
Proportion of patients who have a decrease in joint space of 0.5 mm
Description
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 Outcome Measure Information:
Title
Proportion of patients who have evolution of medial femoral tibial joint space
Description
Evolution of medial femoral-tibial joint space
Time Frame
3 years
Title
Number of particpants who will have evolution of strucutral lesion score
Description
Evolution structural lesion score is OARSI (OsteoArthritis Research Society International score)
Time Frame
3 years
Title
Evolution of algo-functional scores (OAKHQOL)
Description
OAKHQOL (OsteoArthritis of Knee and Hip Quality Of Life) scores
Time Frame
3 years
Title
Evolution of algo-functional scores (WOMAC)
Description
WOMAC (McMaster Western Ontario questionnaire ) scores
Time Frame
3 years
Title
Change From Baseline in quality of life Scores
Description
Short Form 36
Time Frame
3 years
Title
Change From Baseline in Pain Scores on the Visual Analog Scale
Description
Pain visual analogical score
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aurélie DESPUJOLS
Phone
33 2 38 74 40 71
Email
aurelie.despujols@chr-orleans.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Elodie TATSI TOTOUOM
Phone
33 2 38 74 40 86
Email
elodie.tatsi-totouom@chr-orleans.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric LESPESSAILLES, Dr
Organizational Affiliation
CHR Orléans
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Brabois
City
Nancy
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien LOEUILLE, Pr
Phone
33 3 83 15 36 26
Email
d.loeuille@chru-nancy.fr
Facility Name
CHR Orléans
City
Orléans
ZIP/Postal Code
45067
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric LESPESSAILLES, Dr
Phone
33 2 38 74 42 01
Email
eric.lespessailles@chr-orleans.fr
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27742531
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.
Results Reference
background
PubMed Identifier
26085027
Citation
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.
Results Reference
background
PubMed Identifier
21989629
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.
Results Reference
background
PubMed Identifier
23861096
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.
Results Reference
background
PubMed Identifier
19950282
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.
Results Reference
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Multimodal Imaging of Subchondral Bone in Knee Osteoarthritis : Predictive Model
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