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临床试验/NCT05950854
NCT05950854已完成不适用

3D Joint Space Evaluation in Knee Osteoarthritis: The Importance of Weight-bearing and Flexion

Mylène Jansen2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2023年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
试验地点
2
主要终点
Medial joint space width

研究概览

简要总结

Rationale: Osteoarthritis (OA) is mainly characterized by cartilage degeneration. In knee OA, measuring the distance between the tibia and femur, known as the joint space width (JSW), is an often-used method to quantify the progression of the disease or the effectiveness of treatments, because it is an indirect measure of cartilage degeneration. However, JSW is often measured while the patient is standing (weight-bearing) with slightly flexed knees, with a flexion angle of around 7-10 degrees, while direct cartilage thickness measurements are usually performed while the patient is lying down (non-weight-bearing) with an extended leg [1]. Because of this difference in positioning, it is difficult to compare different JSW and cartilage thickness measures, as it is not clear what happens with the JSW distribution in the joint when a patient changes position between weight-bearing/non-weight-bearing and flexion/extension. In this study, we aim to identify the changes that occur in the knee of OA patients under the influence of weight-bearing and/or flexion, to enable comparing joint space measures from different positions. In this research we want to use MRI as a three-dimensional imaging technique because there is no radiation involved..

Objective: To evaluate how the 3D knee joint space distribution in knee OA patients changes under the influence of weight-bearing (upright) and flexion MRI scanning.

Study design: Explorative cross-sectional study. Study population: 21 patients with symptomatic knee osteoarthritis (Kellgren-Lawrence grade 2 or 3) are included from the orthopaedics department of Medisch Spectrum Twente in Enschede.

Main study parameters/endpoints: The primary study parameter is the change in medial joint space width between the different positions (weight-bearing/non-weight-bearing and flexion/extension).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Patients with symptomatic knee osteoarthritis in at least one knee
  • > 18 years old
  • Kellgren-Lawrence grade (severity) 2 or 3
  • Good knowledge of the Dutch language
  • Signed informed consent

排除标准

  • Previous surgery in (both) symptomatic knee(s)
  • Inability to stand for 15 minutes, without assistance
  • Unable to fit knee in the MRI coil (knee width > ~15 cm)
  • Not eligible for MRI, in response to the MRI safety checklist

结局指标

主要结局

Medial joint space width

时间窗: 1 hour

Medial joint space width in four scan positions

次要结局

  • Lateral joint space width(1 hour)

研究者

发起方
Mylène Jansen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mylène Jansen

Assistant Professor

UMC Utrecht

研究点 (2)

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