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 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT02848027
Eligibility Criteria:
Inclusion Criteria:
1. Voluntary signature of the IRB approved Informed Consent
2. Unilateral or bilateral osteoarthritic male or female ages 35-85
3. Pain, swelling, and/or functional disability in the affected knee consistent with osteoarthritis in the knee joint
4. Physical examination consistent with osteoarthritis in one knee joint
5. Kellgren-Lawrence grade 2 or greater knee osteoarthritis and/or diagnostic MRI imaging of the affected knee showing osteoarthritis (i.e. chondral loss, fissuring, defect, bone marrow lesion, meniscus tear, synovial thickening, etc…)
6. Is independent, ambulatory, and can comply with all post-operative evaluations and visits
Exclusion Criteria:
1. Knee injections of any type within 3 months prior to the study.
2. Knee surgery within 6 months prior to the study.
3. Inflammatory or auto-immune based joint diseases or other lower extremity pathology (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, polymyalgia, polymyositis, gout pseudogout)
4. Quinolone or Statin induced myopathy/tendinopathy
5. Severe neurogenic inflammation of the cutaneous nerves about the knee or thigh
6. Contraindications for MRI
7. Condition represents a worker's compensation case
8. Currently involved in a health-related litigation procedure
9. Is pregnant
10. Bleeding disorders
11. Currently taking anticoagulant or immunosuppressive medication
12. Allergy or intolerance to study medication
13. Use of chronic opioid
14. Documented history of drug abuse within six months of treatment
15. Any other condition, that in the opinion of the investigator, that would preclude the patient from enrollment
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
85 Years
Study:
NCT02848027
Study Brief:
Protocol Section:
NCT02848027