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 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT05800457
Eligibility Criteria:
Inclusion Criteria:
1. Males or females over the age of 40 diagnosed with knee osteoarthritis
2. Scheduled for first unilateral total knee arthroplasty
3. Moderate to severe (at least grade two) synovitis and synovial hyperplasia, as determined by ultrasound assessment
4. Referred to the Pre-Admission Clinic at University Hospital
Exclusion Criteria:
1. Bilateral, uni-compartmental, or revision total knee arthroplasty
2. Osteoarthritis due to genetic syndromes (e.g., Ehlers-Danlos Syndrome, etc.)
3. Known inflammatory arthropathy, another rheumatic disease, or disease-modifying anti-rheumatic drug (DMARD) use (e.g. methotrexate, hydroxychloroquine, sulfasalazine, leflunomide, TNF inhibitors, etc.) - note: Gout is NOT an exclusion
4. Joint injection (steroid or viscosupplement) within 12 weeks of Pre-Admission Clinic appointment date
5. Cannot read, write, or understand English (printed instructions are provided in English only)
6. Any factors precluding patients from attending follow-up appointments (e.g., socio-economic limitations, distance from clinic, no access to home/cell phone, etc.).
7. Cognitive impairment or psychological problems that preclude the ability to understand instructions
8. Not able to follow up at routine standard of care post-operative visits
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
41 Years
Maximum Age:
80 Years
Study:
NCT05800457
Study Brief:
Protocol Section:
NCT05800457