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 @ 5:53 PM
Ignite Modification Date:
2025-12-24 @ 5:53 PM
NCT ID:
NCT05086068
Eligibility Criteria:
Inclusion Criteria:
* Primary OA according to the American College of Rheumatology criteria1.
* Self-reported pain, aching, or stiffness of the index knee on most days of the past month, and a knee pain score of greater than 40 out of 100 on a visual analogue scale (VAS).
* Radiological OA greater than Kellgren-Lawrence (K-L) grading scale 2
* Patients aged over 18 years
* Patient willing to undergo synovial sampling at 3 months post injection.
Exclusion Criteria:
* Previous trauma with significant alteration in bone architecture
* Symptoms of spinal disease
* Prior injection in the last 12 months
* Joint re-placement operation on the other knee
* Cognitive disorders
* Inflammatory arthritis (i.e., rheumatoid arthritis, spondylarthritis and gout)
* Fibromyalgia
* Auto-immune disease (i.e., connective tissue disorders)
* Previous history of septic arthritis.
* Unwilling or unable to give informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05086068
Study Brief:
Protocol Section:
NCT05086068