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Completed

NCT Number: NCT05950854

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Twente

Enschede, Overijssel, 7522NB, Netherlands

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Weight-bearing MRI

Diagnostic Test

Four MRI scans with 0.25T scanner: weight-bearing and non-weight-bearing with flexed and extended knee

Primary outcomes

  1. Medial joint space width

    Time frame: 1 hour

    Medial joint space width in four scan positions

Secondary outcomes

  1. Lateral joint space width

    Time frame: 1 hour

    Lateral joint space width in four scan positions

Sponsors and collaborators

Lead sponsor

Mylène Jansen

Other

Collaborators

  • University of Twente

Registry information

Acronym: 3DJSW-MRI

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 18, 2023
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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