An observational study in Knee Osteoarthritis, sponsored by Imperial College London. Not yet recruiting. Open to participants aged 40 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-02.
Sponsored by Imperial College London · Observational
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:
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 70 is below the median of 100 across 791 observational studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →Imperial College London is the lead sponsor of 824 studies on the registry; 178 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
The research team will be recruiting both healthy volunteers and early knee osteoarthritis patients using the inclusion and exclusion criteria detailed above.
Exclusion Criteria For Healthy Volunteers:
Inclusion Criteria for Knee Osteoarthritis Patients:
Exclusion Criteria for Knee Osteoarthritis Patients
This group consists of healthy volunteers with no history of knee joint pain (refer to inclusion/exclusion criteria for more details). They will be scanned once and their scans will be used as the baseline to compare the early knee osteoarthritis patient data with. 10 healthy volunteers will be recruited.
This group consists of early knee osteoarthritis patients (refer to inclusion/exclusion criteria for more details). They will be scanned 4 times over a period of 2 years (at enrolment, 6 months, 12 months and 24 months after enrolment) to see how the disease progresses. Their scans will be compared with the baseline healthy volunteer scans to check for any differences in anatomy and tissue properties. 60 knee osteoarthritis patients will be recruited.
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
The cartilage thickness values will be calculated from the MRI scans that will be acquired.
Time frame: at enrolment, after 6 months, after 12 months and after 24 months
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
The microstructure maps will be calculated from the MRI scans that will be acquired.
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
MRI Osteoarthritis Knee Score (MOAKS) values will be calculated from the MRI scans that will be acquired. MOAKS is a semi-quantitative scoring tool that scores sub-regions of articular cartilage and bone marrow lesions. Different grades are used to score each sub-region. For cartilage sub-region loss, grade 0 indicates no loss and grade 3 indicates over 75% loss.
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
Cartilage thickness will be calculated for scans acquired at the various time points on the 3T and 7T scanners and compared with each other to investigate the change in thickness over the specified time frame.
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
Microstructure maps will be calculated for scans acquired at the various time points on the 3T and 7T scanners and compared with each other to investigate the change in thickness over the specified time frame.
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
No study locations are listed for this record.
Plan to share: No — We will not be sharing IPD with other researchers.
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Imperial College London