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 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT01227694
Eligibility Criteria:
Inclusion Criteria:
1. Gonarthrosis grade II-III of Kellgren and Lawrence assessed by two observers
2. Chronic knee pain with mechanical characteristics
3. Absence of local or systemic septic process
4. Haematological and biochemical laboratory tests without significant alterations that contraindicate treatment.
5. Informed Consent form signed by the patient
6. The patient is able to understand the nature of the study
Exclusion Criteria:
1. Patients \< 18 years or legally dependent
2. Patients \>65 years
3. Previous surgery of the knee
4. Intraarticular treatment in the past 6 month
5. Knee ligament or meniscus rupture observed by MRI
6. Any sign of infection
7. Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg), Hepatitis C (Anti-HCV-Ab) and syphilis.
8. Congenital or acquired malformation resulting in significant deformity of the knee and leading to problems in application or evaluation of results.
9. Overweight expressed as body mass index (BMI) greater than 30.5 (obesity grade II). BMI estimated as mass (kg) / corporal surface (m2).
10. Pregnant women or intend to become pregnant or breast-feeding
11. Neoplasia
12. Immunosuppressive states
13. Participation in another clinical trial or treatment with a different investigational product within 30 days prior to inclusion in the study.
14. Other pathologic conditions or circumstances that difficult participation in the study according to medical criteria
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01227694
Study Brief:
Protocol Section:
NCT01227694