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 @ 9:44 PM
Ignite Modification Date:
2025-12-24 @ 9:44 PM
NCT ID:
NCT02034032
Eligibility Criteria:
Inclusion Criteria:
1. Voluntary signature of the IRB approved Informed Consent
2. Ages 18 to 70
3. Diagnosis of Knee osteoarthritis
4. Kellgren-Lawrence Grade 2 or 3 on X-Ray
5. BMI of \<30
6. Minimum flexion to 110 degrees
7. Varus under 12 degrees/Valgus under 15 degrees
8. Instability in any plane less than 2 mm translation
9. ACL intact and no history of ACL reconstruction
10. Knee Society 100 point score \> 65
11. If bilateral arthritis, subject must be able and willing to delay treatment of the second side for at least 6 months
12. Candidate is able to follow Regenexx medication guidelines
13. Patient agrees to return for periodic assessment protocol
14. Patient must execute all required documents
15. Patient must be appraised of Clinical Trial
Exclusion Criteria:
1. History of infection of the joint in the last five years
2. Intra-articular PRP, steroid or viscosupplementation in the last three months
3. Previous knee surgery within the last 6 months
4. Flexion contracture over 15 degrees
5. Low back pain with radiculopathy or with "significant" radiographic changes
6. History of immunosuppressive or chemotherapy in the last five years
7. Systemic neurological disease
8. HIV positive or chronic hepatitis
9. Any significant co-morbidity that in the opinion of the investigator should exclude the subject from the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02034032
Study Brief:
Protocol Section:
NCT02034032