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 @ 3:11 AM
Ignite Modification Date:
2025-12-25 @ 3:11 AM
NCT ID:
NCT03710005
Eligibility Criteria:
Inclusion Criteria:
* Age greater than 20 years but less than 75 years old
* Both male and female (non-pregnant)
* Valid knee radiograph within 3 months of beginning treatment;
* Diagnosis of OA of the knee
* OA pain in the knee despite conservative measures
* Average daily VAS \>= 3
* Off any NSAIDs for 1 week prior to injection, may then continue for no more than 5 consecutive days after injection
* Kellgren-Lawrence system of Grade II, III, or IV
Exclusion Criteria:
* Kellgren-Lawrence Grade I
* Tense effusion of the knee
* Significant valgus/varus deformities
* Viscosupplementation within 6 months
* Surgery in the knee within the past 6 months Systemic or intraarticular injection of costicosteroids in any joint within 3 months before screening
* Chronic opioid usage
* History of Leukemia or Lymphoma
* History of any autoimmune disorders and disease
* Immunosuppressive medications
* Active, suspected, or prior infection to the joint
* Vulnerable populations (pregnant women and breast-feeding women, cognitively impaired, prisoners, etc...)
* NSAIDs used within 1 week of the procedure
* History of bleeding disorders or inflammatory joint disease
* Patients who plan on becoming pregnant during study period
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT03710005
Study Brief:
Protocol Section:
NCT03710005