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 @ 7:50 PM
Ignite Modification Date:
2025-12-24 @ 7:50 PM
NCT ID:
NCT04000204
Eligibility Criteria:
Inclusion Criteria:
1. age from 35 to 85 years;
2. radiographic Kellgren-Lawrence grade II to III;
3. symptoms ≧6 months despite conservative treatments such as analgesics, NSAID and/or physical therapy;
4. average knee pain score ≧30mm on 100-mm visual analog scale (VAS) in recent one week;
5. radiographic evidence of bilateral knee OA not reason for exclusion if VAS pain in contralateral knee \<30mm.
Exclusion Criteria:
1. previous orthopedic surgery in the lower extremity;
2. disabling osteoarthritis of hip or ankle;
3. previous IAHA within 6 months;
4. IA steroid or joint puncture within 3 months;
5. characters of severe acute synovitis under ultrasound (US) examination, such as Grade 3 in suprapatellar synovitis (SPS), suprapatellar effusion (SPE), medial compartment synovitis (MCS) or lateral compartment synovitis (LCS);
6. Any specific medical condition, such as rheumatoid arthritis, Lupus erythematous, hemiparesis, infection, neoplasm, and etc., that would interfere with assessments;
7. confirmed or suspected pregnancy or lactating;
8. known allergy history to any avian protein or HA product.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
85 Years
Study:
NCT04000204
Study Brief:
Protocol Section:
NCT04000204