Quantitative MRI For Detection and Tracking of Knee Osteoarthritis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Knee Osteoarthritis. Basic parameters: 40 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Quantitative MRI For Detection And Tracking of Disease Progression Over 2 Years In Early Knee Osteoarthritis Patients & Healthy Volunteers
Overview
The goal of this observational study is to develop whole-joint quantitative MRI techniques that aid in the detection and tracking of osteoarthritis disease progression at 3T and 7T MRI scanners. The research objectives are: 1. Compare the relative accuracies of 7T and 3T MRI in detecting clinical osteoarthritis progression. 2. Compare the quantitative MRI measures developed with the results acquired from the following two questionnaires: Knee Injury and Osteoarthritis Outcome Score (KOOS) and the Visual Analogue Score (VAS). 3. Measure the repeatability of 7T and 3T quantitative MRI methods developed in whole-joint knee imaging 4. Optimize the quality and efficiency of 7T and 3T whole-joint knee MRI Participants will be scanned at the 3T scanner at the Clinical Imaging Facility at Hammersmith Hospital and/or the 7T scanner at the LOCUS Center at St Thomas' Hospital. Knee osteoarthritis volunteers will be asked to fill out two questionnaires and will be scanned 4 times over a 2 year period (at enrolment, after 6 months, after 12 months and after 24 months) while healthy volunteers will be scanned once at enrolment. Both healthy volunteers and knee osteoarthritis patients will be asked to fill out MRI safety forms before entering the scanner room, and both groups will be scanned up to 90 minutes during each session. Researchers will compare knee osteoarthritis patients with healthy volunteers to see how their knee anatomy and tissue properties differ.
Primary outcome measures
- Reproducibility of cartilage thickness values at 3T and 7T as a measure of knee osteoarthritis at enrolment, after 6 months, after 12 months and after 24 months [Time frame: at enrolment, after 6 months, after 12 months and after 24 months]
Secondary outcome measures (6)
- Reproducibility of microstructure maps at 3T and 7T as a measure of knee osteoarthritis at enrolment, after 6 months, after 12 months and after 24 months [Time frame: at enrolment, after 6 months, after 12 months and after 24 months]
- Reproducibility of MOAKS analysis at 3T and 7T as a measure of knee osteoarthritis at enrolment, after 6 months, after 12 months and after 24 months [Time frame: at enrolment, after 6 months, after 12 months and after 24 months]
- Calculate and compare the longitudinal changes in cartilage thickness at 3T and 7T over the 2 year period [Time frame: at enrolment, after 6 months, after 12 months and after 24 months]
- Calculate and compare the longitudinal changes in microstructure maps at 3T and 7T over the 2 year period [Time frame: at enrolment, after 6 months, after 12 months and after 24 months]
- Calculate minimum detectable effect size for osteoarthritis progression at 3T and 7T with cartilage thickness [Time frame: at enrolment, after 6 months, after 12 months and after 24 months]
- Calculate minimum detectable effect size for osteoarthritis progression at 3T and 7T with microstructure maps [Time frame: at enrolment, after 6 months, after 12 months and after 24 months]
Eligibility criteria
Inclusion Criteria For Healthy Volunteers:
- All people between 40 to 70 years of age
- All people with no history of knee injury, surgery, or knee pain
Exclusion Criteria For Healthy Volunteers:
- Patients with body mass index of more than 35, or body geometry that prevents scanning due to MRI scanner bore width or knee coil diameter
- Patients with varus or valgus malalignment
- Patients with contraindications to MRI
- Patients lacking capacity to consent
- Patients who are pregnant or breast-feeding
- Patients who are participating in a clinical trial(s) for new drugs and/or therapies
Inclusion Criteria for Knee Osteoarthritis Patients:
- All patients with primary osteoarthritis (grade 2-3 per Kellgren-Lawrence Scale)
- Patients who have had radiographs taken as part of their routine clinical care agreed with their orthopaedic surgeon, Mr Gareth Jones. Note that their radiographs must have been acquired a maximum of three weeks from the first, baseline scanning session. This radiograph will be used to check if patients have primary osteoarthritis.
- All patients between 40 to 70 years of age
Exclusion Criteria for Knee Osteoarthritis Patients
- Patients with body mass index of more than 35, or body geometry that prevents scanning due to MRI scanner bore width or knee coil diameter
- Patients with varus or valgus malalignment of more than 5°
- Patients with radiographic osteoarthritis (grade ≥4 per Kellgren-Lawrence Scale, obtained from radiographs)
- Patients with contraindications to MRI
- Patients lacking capacity to consent
- Patients who are pregnant or breast-feeding
- Patients who are participating in a clinical trial(s) for new drugs and/or therapies
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06063304 · 22IC8098