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 @ 3:42 PM
Ignite Modification Date:
2025-12-24 @ 3:42 PM
NCT ID:
NCT02610192
Eligibility Criteria:
Inclusion Criteria:
* Patient must be female
* Isolated patellofemoral osteoarthritis (PFOA) in one or both knees as diagnosed by the treating physician
* Objective evidence of PFOA on one or both of a radiograph or MRI taken within 3 months of treatment
* From 40-65 years of age, inclusive at time of injection
* Symptoms return such that there is a need for further treatment within 3 months of a corticosteroid or hyaluronic acid injection
* Willing and able to comply with the study procedures
* Sign informed consent form
Exclusion Criteria:
* Any systematic inflammatory condition (e.g. rheumatoid arthritis)
* Active malignancy at time of injection
* Pregnant at time of injection
* Lactating at time of injection
* Knee joint infections or skin diseases or infections in the area of the injection site
* Leukemia, metastatic malignant cells, or who are receiving chemotherapeutic treatment
* Participation in another device, biologic or drug study
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
40 Years
Maximum Age:
65 Years
Study:
NCT02610192
Study Brief:
Protocol Section:
NCT02610192