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 @ 2:37 AM
Ignite Modification Date:
2025-12-25 @ 2:37 AM
NCT ID:
NCT02823834
Eligibility Criteria:
Inclusion Criteria:
* Has undergone primary THA for any of the following:
* Non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, or painful hip dysplasia;
* Inflammatory degenerative joint disease such as rheumatoid arthritis; or
* Correction of functional deformity
* Subject is implanted with the specified combination of components
* Subject is willing and able to complete required study visits or assessments
Previously implanted bilateral subjects can have both THAs enrolled in the study provided:
* the specified combination of components were implanted in both
* all other aspects of the Inclusion/Exclusion Criteria are satisfied
* enrollment does not exceed the subject count specified in the Clinical Trial Agreement
* the subject agrees to a second Informed Consent document specific to the second THA.
Exclusion Criteria:
* Subjects implanted with a metal-on-metal articulation
* Subjects implanted with non-MPO or non-Wright Medical Technology components (femoral heads, acetabular shells, acetabular liners) at the time of their primary THA in the enrolled THA
* Subjects skeletally immature (less than 21 years of age) at time of primary THA surgery
* Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol
* Subjects unwilling to sign the Informed Consent document
* Subjects with substance abuse issues
* Subjects who are incarcerated or having pending incarceration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02823834
Study Brief:
Protocol Section:
NCT02823834