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 @ 11:59 AM
Ignite Modification Date:
2025-12-24 @ 11:59 AM
NCT ID:
NCT04001361
Eligibility Criteria:
Inclusion Criteria:
Kellergren grading scale of 2 or 3 in at least one compartment of either or both knees with no compartment representing a stage 4 in either knee.
No significant MCL or LCL tear or laxity
No significant meniscal tear. ( i.e. bucket handle)
Exclusion Criteria:
* Injection with the past 6 weeks
* Stage 4 osteoarthritis in either knee
* Uncontrolled Diabetes or any other metabolic syndrome
* BMI greater than 28
* Significant lower extremity deformity
* Bilateral or tri compartmental Knee OA
* Adults unable to consent
* Individuals who are not yet adults (infants, children, and teenagers, age \< 18)
* pregnant women
* Prisoners
* Stage 4 osteoarthritis in either knee
* Subjects, who, in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04001361
Study Brief:
Protocol Section:
NCT04001361