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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT06685120
Eligibility Criteria:
Inclusion Criteria:
1. Male or female patients, aged 40 to 75 years;
2. Patients with symptomatic knee osteoarthritis (VAS pain score between ≥ 3 and ≤ 8);
3. Unilateral involvement of symptomatology;
4. Radiographic or MRI signs of degenerative pathology of knee cartilage (Kellgren-Lawrence grade 1-3);
5. Failure, defined as the persistence of symptomatology, after at least one course of conservative treatment (pharmacological, physiotherapeutic or infiltrative treatment);
6. Hemoglobin \> 11 g/dl; Platelet count \> 150,000 plt/mm3 (Recently performed CBC examination);
7. Ability and consent of patients to actively participate in clinical follow-up;
8. Signature of informed consent.
Exclusion Criteria:
1. Patients unable to express consent;
2. Patients undergoing intra-articular infiltration of other substance in the previous 6 months;
3. Patients undergoing knee surgery in the previous 12 months;
4. Patients with malignant neoplasms;
5. Patients with rheumatic diseases;
6. Patients with uncontrolled diabetes;
7. Patients with hematological diseases (coagulopathies);
8. Patients on anticoagulant-antiaggregant therapy that cannot be discontinued at the time of blood collection;
9. Patients with uncompensated thyroid metabolic disorders;
10. Patients abusing alcoholic beverages, drugs or medications;
11. Body Mass Index \> 35;
12. Patients who have taken NSAIDs in the 3 days prior to blood draw;
13. Patients with cardiovascular disease for whom blood sampling 30 to 60 ml would be contraindicated;
14. Patients with recently performed CBC examination with Hb\< 11 g/dl and Platelet values \< 150,000 plt/mm3.
15. Pregnant and/or fertile women.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT06685120
Study Brief:
Protocol Section:
NCT06685120