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 @ 9:37 PM
Ignite Modification Date:
2025-12-24 @ 9:37 PM
NCT ID:
NCT05160532
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of knee OA by clinical criteria (American College of Rheumatology).
* Identification of knee osteoarthritis by a radiologist on an existing knee radiograph obtained within 3 years of enrollment.
* Moderate to severe knee pain for at least 3 months, defined as a score of ≥ 4 (on a 0-10 point numeric rating scale) in response to the question "What is the average level of your left/right knee pain in the past 3 months?".
Exclusion Criteria:
* Pregnancy.
* Diabetes.
* Anticoagulation therapy.
* History of total knee replacement.
* Prior knee prolotherapy or other regenerative product.
* Any knee injection within 3 months.
* Inflammatory (RA, gout, pseudogout etc.) or postinfectious knee arthritis.
* Daily use of opioid medication.
* Allergy or intolerance to study medication, corn allergy.
* Body mass index (BMI) greater than 40 kg/m\^2.
* Comorbidity severe enough to prevent participation in the study protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT05160532
Study Brief:
Protocol Section:
NCT05160532