Multimodal Imaging of Subchondral Bone in Knee Osteoarthritis : Predictive Model

NCT03294408 | Completed

• 2 other identifiers: CHRO-2016-012016-A00552-49
• Study Type: interventional
• Target: 167
• Locations: 1 country
• Sites: 2

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.

Conditions

Knee Osteoarthritis; Joint Disease; Arthritis; Musculoskeletal Disease

Keywords

fractal analysis; trabecular bone texture; knee osteoarthritis; subchondral bone; Medical Resonnance Imaging

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Proportion of patients who have evolution of medial femoral tibial joint space

  3 years

• Number of particpants who will have evolution of strucutral lesion score

  3 years

• Evolution of algo-functional scores (OAKHQOL)

  3 years

• Evolution of algo-functional scores (WOMAC)

  3 years

• Change From Baseline in quality of life Scores

  3 years

Study Arms (1)

Imaging

OTHER

multimodal imaging and clinical assessment

Diagnostic Test: multimodal imaging

Interventions

multimodal imaging DIAGNOSTIC_TEST

Also known as: clinical assessment

Imaging

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patello-femoral degenerative osteoarthritis isolated.
• Incapacitated to consider the position in schuss for the realization of the radiography.
• Valgus \> in 5 °
• Secondary degenerative osteoarthritis

Sponsors & Collaborators

• Centre Hospitalier Régional d'Orléans: lead
• University of Nancy: collaborator

Study Sites (2)

Chu Brabois

Nancy, 54511, France

Location

CHR Orléans

Orléans, 45067, France

Location

Related Publications (5)

• 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.

  PMID: 27742531 BACKGROUND

• 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.

  PMID: 26085027 BACKGROUND

• 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.

  PMID: 21989629 BACKGROUND

• 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.

  PMID: 23861096 BACKGROUND

• 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.

  PMID: 19950282 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Joint Diseases; Arthritis; Musculoskeletal Diseases

Interventions

Multimodal Imaging

Condition Hierarchy (Ancestors)

Osteoarthritis; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Eric LESPESSAILLES, Dr

  CHR Orléans

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 4, 2017
• First Posted: September 27, 2017
• Study Start: November 29, 2016
• Primary Completion: June 19, 2023
• Study Completion: June 19, 2023
• Last Updated: November 28, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)