Clinical trial NCT03294408: Multimodal Imaging of Subchondral Bone in Knee Osteoarthritis : Predictive Model
Official title: Capacity of Multimodal Imaging of Subchondral Bone for the Prediction of Structural Evolution in Knee Osteoarthritis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Knee Osteoarthritis
Joint Disease
Arthritis
Musculoskeletal Disease
Keywords: fractal analysis
trabecular bone texture
knee osteoarthritis
subchondral bone
Medical Resonnance Imaging
Lead sponsor: Centre Hospitalier Régional d'Orléans
Sponsor class: OTHER
Collaborators: name: University of Nancy
First posted: 2017-09-27
Enrollment: 167
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Proportion of patients who have one-point increase in the quality score of OARSI
timeFrame: 3 years
measure: Proportion of patients whose joint space reduction is greater than the smallest reliable detectable difference.
timeFrame: 3 years
measure: Proportion of patients who have a decrease in joint space of 0.5 mm
timeFrame: 3 years
Secondary outcomes:
measure: Proportion of patients who have evolution of medial femoral tibial joint space
timeFrame: 3 years
measure: Number of particpants who will have evolution of strucutral lesion score
timeFrame: 3 years
measure: Evolution of algo-functional scores (OAKHQOL)
timeFrame: 3 years
measure: Evolution of algo-functional scores (WOMAC)
timeFrame: 3 years
measure: Change From Baseline in quality of life Scores
timeFrame: 3 years
measure: Change From Baseline in Pain Scores on the Visual Analog Scale
timeFrame: 3 years
Other outcomes:
Locations:
city: Nancy
country: France
facility: Chu Brabois
city: Orléans
country: France
facility: CHR Orléans
Study officials:
affiliation: CHR Orléans
name: Eric LESPESSAILLES, Dr
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.