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 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT04061733
Eligibility Criteria:
Inclusion Criteria:
1. Subjects diagnosed with osteoarthritis of unilateral or bilateral knee osteoarthritis who meet the criteria defined by the American College of Rheumatology for at least 4 months prior to the study. In bilateral knee osteoarthritis, only the knee with more symptoms will be treated.
2. Arthrosis grade 2 or 3 according to the Kellgren - Lawrence Classification System (radiological classification)
3. Persistence of symptoms despite conservative treatment (NSAIDS, Physical Therapy, lifestyle changes, etc.) for more than 4 months
4. Subjects aged between 40 and 70 years
5. BMI (Kg/m²) 20-32
6. For female subjects: postmenopausal women with at least 1 year documented in the medical record.
Exclusion Criteria:
1. Arthrosis grade 0 or 4 according to the Kellgren - Lawrence Classification
2. History of allergy to any of the Hydrogel components
3. History of previous treatment with corticosteroid injections less than 4 months prior to entry into this clinical study
4. History of previous treatment with hyaluronic acid viscosupplementation
5. History of open or arthroscopic surgery in the knee to be treated less than 9 months
6. Severe chronic progressive disease
7. Insulin-requiring diabetes
8. Rheumatic diseases (rheumatoid arthritis, psoriasis, gout, pseudo-gout, fibromyalgia)
9. History of septic arthritis
10. History of psychiatric illness that makes it impossible to understand and sign the informed consent
11. History or presence of severe peripheral vascular disease
12. Deseje over 15° valgus or varus movement
13. Pregnant or breastfeeding women
14. BMI (kg/m²)\> 32
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT04061733
Study Brief:
Protocol Section:
NCT04061733