Osteoarthritis, Knee3DJSW-MRINCT05950854
3D Joint Space Evaluation in Knee Osteoarthritis: The Importance of Weight-bearing and Flexion
An observational study of Osteoarthritis, Knee, run by Mylène Jansen at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Weight-bearing MRI
- How many people
- 21 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Nov 2023to 25 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with symptomatic and radiographic (Kellgren-Lawrence grade 2-3) knee osteoarthritis eligible for MRI scanning
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
- Being tested
- Weight-bearing MRI
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight-bearing MRIDiagnostic test
Four MRI scans with 0.25T scanner: weight-bearing and non-weight-bearing with flexed and extended knee
What is being measured
The primary outcome is the main question the study is designed to answer.
Medial joint space width
Medial joint space width in four scan positions
Measured: 1 hour
Secondary outcomes (1)
Lateral joint space width
Lateral joint space width in four scan positions
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start1 Nov 2023
- Primary completion25 Sep 2024
- Study completion25 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mylène Jansen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Twente
- Responsible party
- Sponsor-investigator, Mylène Jansen, UMC Utrecht
- Investigators
- Wyger Brink, PhD, Principal investigator, University of TwenteSimon Mastbergen, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950854
- Sponsor's protocol ID
- 23-040
- Acronym
- 3DJSW-MRI
- Status last verified
- May 2026
- First submitted
- 6 Jul 2023
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Joint Space Evaluation in Knee Osteoarthritis: The Importance of Weight-bearing and Flexion
- ClinicalTrials.gov ID
- NCT05950854
- Acronym / sponsor ID
- 3DJSW-MRI / 23-040
- Conditions
- Osteoarthritis, Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Mylène JansenUniversity, hospital or other
- Collaborators
- University of Twente
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 25 Sep 2024 (actual)
- Study completion
- 25 Sep 2024 (actual)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with symptomatic and radiographic (Kellgren-Lawrence grade 2-3) knee osteoarthritis eligible for MRI scanning
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weight-bearing MRIFour MRI scans with 0.25T scanner: weight-bearing and non-weight-bearing with flexed and extended knee | Diagnostic test | – |
Primary outcome
Medial joint space width
Time frame: 1 hour
Medial joint space width in four scan positions
1 secondary outcome
Lateral joint space width
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wyger Brink, PhD principal investigator
University of Twente
Simon Mastbergen, PhD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by Mylène Jansen at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Medial joint space width (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.