Clinical trial NCT05950854: 3D Joint Space Evaluation in Knee Osteoarthritis: The Importance of Weight-bearing and Flexion
Official title: 3D Joint Space Evaluation in Knee Osteoarthritis: The Importance of Weight-bearing and Flexion
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Osteoarthritis, Knee
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: University of Twente
First posted: 2023-07-18
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with symptomatic and radiographic (Kellgren-Lawrence grade 2-3) knee osteoarthritis eligible for MRI scanning

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).


Eligibility criteria: 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

Primary outcomes:
measure: Medial joint space width
timeFrame: 1 hour
Secondary outcomes:
measure: Lateral joint space width
timeFrame: 1 hour
Other outcomes:
Locations:
city: Enschede
country: Netherlands
facility: University of Twente
state: Overijssel
Study officials:
affiliation: University of Twente
name: Wyger Brink, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UMC Utrecht
name: Simon Mastbergen, PhD
role: PRINCIPAL_INVESTIGATOR
References: