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 @ 1:06 AM
Ignite Modification Date:
2025-12-25 @ 1:06 AM
NCT ID:
NCT02309593
Eligibility Criteria:
Inclusion Criteria:
* Subject previously underwent / is a candidate for 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 has been previously implanted / is a candidate to be implanted with the specified combination of components
* Subject is willing and able to complete required study visits or assessments
* Not previously implanted subject is able to undergo primary THA procedure
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
Prospective enrollment of a previously unimplanted contralateral hip is permitted in this study provided:
* it occurs not more than two years after the index THA
* the specified combination of components is used
* 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:
* Subject is skeletally immature (less than 21 years of age) at time of primary THA surgery
* Subject is currently enrolled in another clinical study which could affect the endpoints of this protocol
* Subject is unwilling to sign the Informed Consent document
* Subject has substance abuse issues
* Subject is incarcerated or has pending incarceration
* Subject is anticipated to require a contralateral THA less than 1 year after the index THA on the enrolled hip
In addition, not previously implanted subjects will be excluded if they meet any of the following criteria:
* Subject has any of the following contraindications at the time of implantation
* Overt infection
* Distant foci of infections (which may cause hematogenous spread to the implant site)
* Rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram
* Inadequate neuromuscular status (e.g., prior paralysis, fusion, and/or inadequate abductor strength), poor bone stock, poor skin coverage around the joint which would make the procedure unjustifiable
* Neuropathic joints
* Hepatitis or HIV infection
* Neurological or musculoskeletal disease that may adversely affect gait or weight-bearing
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT02309593
Study Brief:
Protocol Section:
NCT02309593