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

Osteoarthritis, Knee Clinical Trial

— 3DJSW-MRI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05950854
• Other study ID #: 23-040
• Status: Recruiting
• Start date: November 1, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: May 2024
• Source: UMC Utrecht
• Contact: Mylène Jansen, PhD
• Phone: +31887555639
• Email: m.p.jansen-36[@]umcutrecht.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

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

Locations

Country	Name	City	State
Netherlands	University of Twente	Enschede	Overijssel

Sponsors (2)

Lead Sponsor	Collaborator
Mylène Jansen	University of Twente

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medial joint space width	Medial joint space width in four scan positions	1 hour
Secondary	Lateral joint space width	Lateral joint space width in four scan positions	1 hour