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

NCT05950854 | Completed

• 1 other identifier: 23-040
• Study Type: observational
• Target: 21
• Locations: 1 country
• Sites: 1

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).

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• Medial joint space width

  Medial joint space width in four scan positions

  1 hour

Secondary Outcomes (1)

• Lateral joint space width

  1 hour

Interventions

Weight-bearing MRI DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with symptomatic and radiographic (Kellgren-Lawrence grade 2-3) knee osteoarthritis eligible for MRI scanning

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mylène Jansen: lead
• University of Twente: collaborator

Study Sites (1)

University of Twente

Enschede, Overijssel, 7522NB, Netherlands

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Wyger Brink, PhD

  University of Twente

  PRINCIPAL INVESTIGATOR

• Simon Mastbergen, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 18, 2023
• Study Start: November 1, 2023
• Primary Completion: September 25, 2024
• Study Completion: September 25, 2024
• Last Updated: May 8, 2026

Record last verified: 2026-05

Locations

NL (1)