跳至主要内容
临床试验/NCT03294408
NCT03294408已完成不适用

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

Centre Hospitalier Régional d'Orléans4 个研究点 分布在 1 个国家目标入组 167 人开始时间: 2016年11月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
167
试验地点
4
主要终点
Proportion of patients who have one-point increase in the quality score of OARSI

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
45 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Proportion of patients who have one-point increase in the quality score of OARSI

时间窗: 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.

时间窗: 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

时间窗: 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).

次要结局

  • Change From Baseline in quality of life Scores(3 years)
  • Number of particpants who will have evolution of strucutral lesion score(3 years)
  • Evolution of algo-functional scores (OAKHQOL)(3 years)
  • Change From Baseline in Pain Scores on the Visual Analog Scale(3 years)
  • Evolution of algo-functional scores (WOMAC)(3 years)
  • Proportion of patients who have evolution of medial femoral tibial joint space(3 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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