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 @ 2:16 AM
Ignite Modification Date:
2025-12-25 @ 2:16 AM
NCT ID:
NCT06905860
Eligibility Criteria:
Inclusion Criteria:The following inclusion criteria will be followed:
* Age 50 years or older
* Who have not improved with non-surgical treatment for at least 3 months, ability to sign a consent form, average visual analog scale \> 40/100 (over at least 7 days in the previous month)
* Mild or moderate knee osteoarthritis diagnosed by radiographic imaging grade 2 or 3 according to the Kellgren-Lawrence classification.
Exclusion Criteria: The exclusion criteria will be:
-Absence from work due to disability benefits or income reduction assistance (worker's compensation). Whenever one of the investigators believes that a participant may be simulating a worse health condition than reality to receive financial assistance with work absence, they will be excluded from the study.
The following non-inclusion criteria will be observed:
* Angular deviation \>10º of varus or valgus in relation to the anatomical neutral axis in the coronal plane assessed clinically with a goniometer (anatomical axis of the femur x anatomical axis of the tibia \> 4º varus or \> 16º valgus)
* Body Mass Index (BMI)\>35 or \<18
* Smoking
* Autoimmune inflammatory disease - rheumatological
* Diabetes - with HbA1c \> 7
* Chronic kidney disease
* Coagulopathies
* severe cardiovascular diseases
* infections or immunodeficiencies
* active or treated malignant neoplasia
* use of NSAIDs in the last month
* use of corticosteroids in the last 3 months
* platelets \< 150,000
* recent intra-articular corticosteroid injection or recent HA injection (in the last 6 months)
* pregnancy or suspected pregnancy
* psychiatric disorders.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT06905860
Study Brief:
Protocol Section:
NCT06905860