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

Sponsor
Mylène Jansen (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05950854
Collaborator
University of Twente (Other)
21
12

Study Details

Study Description

Brief Summary

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).

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Weight-bearing MRI

Study Design

Study Type:
Observational
Anticipated Enrollment :
21 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
3D Joint Space Evaluation in Knee Osteoarthritis: The Importance of Weight-bearing and Flexion
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Outcome Measures

Primary Outcome Measures

  1. Medial joint space width [1 hour]

    Medial joint space width in four scan positions

Secondary Outcome Measures

  1. Lateral joint space width [1 hour]

    Lateral joint space width in four scan positions

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Mylène Jansen
  • University of Twente

Investigators

  • Principal Investigator: Wyger Brink, PhD, University of Twente
  • Principal Investigator: Simon Mastbergen, PhD, UMC Utrecht

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mylène Jansen, Assistant Professor, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT05950854
Other Study ID Numbers:
  • 23-040
First Posted:
Jul 18, 2023
Last Update Posted:
Jul 18, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 18, 2023