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 @ 10:58 PM
Ignite Modification Date:
2025-12-24 @ 10:58 PM
NCT ID:
NCT03519269
Eligibility Criteria:
Inclusion Criteria:
* age between 40 and 85
* body mass index (BMI) less than 40.0 kg/m\^2
* end-stage knee osteoarthritis (Kellgren and Lawrence grade 4)
* failure of a minimum 12 weeks of nonoperative management
* English fluency
Exclusion Criteria:
* history of inflammatory arthropathy in the same knee
* history of prior open knee surgery in the same knee
* history of prior osteotomy or periarticular fracture
* deformity \> 15 degrees from a neutral mechanical axis
* gross ligamentous incompetence of the medial or lateral collateral ligaments
* musculoskeletal involvement beyond unilateral knee osteoarthritis significantly limiting their function
* unwillingness or inability to participate in the proposed study protocol and follow-up
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT03519269
Study Brief:
Protocol Section:
NCT03519269