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 @ 2:15 AM
Ignite Modification Date:
2025-12-25 @ 2:15 AM
NCT ID:
NCT01365260
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic unilateral knee tibiofemoral OA
* Radiographic evidence of knee OA of Kellgren-Lawrence Grade II or III in one or both knees on a recent 3 months time X-Ray
* Knee pain within the last 24 hours before assessment more than 40mm on VAS
* Pain on most days in the last month
Exclusion Criteria:
* Knee pain equal or more than 80mm on a 100mm VAS.
* Pain in the contra lateral knee; more than 30mm on a 100 VAS.
* Concomitant inflammatory joint disease (e.g. gout, rheumatoid arthritis, history of Reiter's syndrome, psoriatic arthritis and ankylosing spondylitis.
* Any condition that may interfere with the measure of pain in the targeted knee
* Concomitant meaningful synovial fluid effusion
* Post trauma OA
* Gross ligamentous instability of the knee
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Study:
NCT01365260
Study Brief:
Protocol Section:
NCT01365260