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 @ 12:02 PM
Ignite Modification Date:
2025-12-24 @ 12:02 PM
NCT ID:
NCT03491761
Eligibility Criteria:
Inclusion Criteria:
* Ability to provide informed consent
* Chronic pain (\>3 months)
* Grade 2 -3 according to Kellgren- Lawrence (K-L) classification system (using bilateral anteroposterior radiograph image acquired while the patient is weight-bearing with both knees in full extension)
* Minimum score of 40 out of possible 100 on the VAS (Visual Analog Scale) for pain
* Age 18 to 75 years old
* Physical exam and medical history
* Complete Blood Count to include platelets and differential (CBC with Diff) within normal limits
* C-Reactive Protein (CRP) within normal limits
* Sed Rate (ESR) within normal limits
* Survey of current medications
Exclusion Criteria:
* Presence of major axial deformity (\>5° valgus or varus deviation)
* Surgery on target knee within 12 months prior to scheduled treatment
* Autoimmune disorder
* Active infections
* Immuno-suppression (e.g., AIDS, etc.)
* Anti-coagulant therapy
* Use of NSAIDs 5 days prior to blood draw or up to 7 days after last PRP / HA treatment
* Hemoglobin (Hg) \<12 g/dL
* Platelet counts (PLT) \<150,000 /mm3
* Previous infiltrative treatment within 3 weeks prior to scheduled treatment
* Pregnancy/Breastfeeding
* Hypersensitivity to HA
* Inability to complete an MRI due to metal implants or claustrophobia
* Diabetes
* Active treatment for a malignancy
* Active wound in the knee
* Recent history of knee trauma
* Vasovagal history
* An injection of hyaluronic acid (HA) or platelet-rich plasma (PRP) to the affected knee within the last two years.
* In the judgment of the investigator, the patient is unable to perform and/or complete all of the study visits or treatments required.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT03491761
Study Brief:
Protocol Section:
NCT03491761