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 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT04641351
Eligibility Criteria:
Inclusion Criteria:
1. Male or female age 40 and older
2. Scheduled for APM with enrolling surgeon
3. Arthroscopic evidence of structural OA including at least one surface with grade 2 chondral change
4. Written informed consent (and assent when applicable) obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
Exclusion Criteria:
1. Females who are pregnant or nursing or plan to become pregnant during the study; men who plan to inseminate a partner or donate sperm
2. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
3. Known or suspected hypersensitivity to Zilretta (or component of Zilretta) or triamcinolone acetonide
4. Kellgren and Lawrence Grade IV (severe OA; arthroplasty is typically preferred over APM in this setting)
5. Injection with corticosteroid into affected knee in past 12 weeks
6. Injection with platelet rich plasma into affected knee in past 12 weeks
7. Injection with hyaluronic acid into affected knee in past 24 weeks
8. Plan for cartilage resurfacing procedure (microfracture, autologous chondrocyte implantation, osteochondral autograft or allograft), ligament reconstruction or other open procedure
9. Bilateral surgery
10. Unable to undergo MRI due to implanted medical device, aneurysm clamp, metal fragments in eye, etc.
11. Absence of at least one area of grade 2 chondral change on diagnostic arthroscopy (patients without structural OA are excluded)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Study:
NCT04641351
Study Brief:
Protocol Section:
NCT04641351