- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05950854
3D Joint Space Evaluation in Knee Osteoarthritis: The Importance of Weight-bearing and Flexion (3DJSW-MRI)
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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Overijssel
-
Enschede, Overijssel, Netherlands, 7522NB
- University of Twente
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Medial joint space width
Time Frame: 1 hour
|
Medial joint space width in four scan positions
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lateral joint space width
Time Frame: 1 hour
|
Lateral joint space width in four scan positions
|
1 hour
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Wyger Brink, PhD, University of Twente
- Principal Investigator: Simon Mastbergen, PhD, UMC Utrecht
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-040
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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