Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-24 @ 9:19 PM
NCT ID:
NCT06063304
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
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT06063304
Study Brief:
Protocol Section:
NCT06063304