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:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT04325334
Eligibility Criteria:
Inclusion Criteria:
ALL:
* aged greater than 40 years
* recreational runners who run at least twice per week for a total of at least 10 km, and have done so for a minimum of 12 months
* comfortable running on a treadmill for 30 minutes.
TFOA Group:
* exhibit radiographic evidence of mild or moderate tibiofemoral osteoarthritis (TFOA) according to the Kellgren and Lawrence OA classification scale (grade ≥ 2)
* report knee pain on most days of the previous 3 months (during running and activities of daily living).
Control Group:
* free of any radiographic signs of TFOA according to the Kellgren and Lawrence scale (grade = 0)
* pain free in both knees for the 12 months prior to recruitment.
Exclusion Criteria:
ALL:
* any history of traumatic knee injury (fracture, severe sprain, meniscus injury)
* presence of an inflammatory arthritic condition
* presence of any health condition (other than OA in the TFOA group) affecting normal movement or precludes engaging in moderate to high impact activities such as running
* use of any oral or injected corticosteroids or viscosupplementation in the previous 6 months
* any history of surgery in either knee
* standard contra-indications to magnetic resonance imaging (MRI).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT04325334
Study Brief:
Protocol Section:
NCT04325334