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 @ 2:52 PM
Ignite Modification Date:
2025-12-24 @ 2:52 PM
NCT ID:
NCT04147559
Eligibility Criteria:
Inclusion Criteria:
1\. Has previously undergone or currently has determined to undergo primary THA with the specified combination of components: PROFEMUR® Preserve Classic Stem combined with other Wright Medical Technologies (WMT) or MPO THA components including acetabular shells, acetabular liners and femoral heads.
2\. Has previously undergone or currently has been determined to undergo a primary THA for any of the following:
* non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
* inflammatory degenerative joint disease such as rheumatoid arthritis;
* correction of functional deformity 3. Willing and able to complete required study visits and assessments through the 10 year postoperative follow-up visit 4. Previously implanted subjects must be enrolled within 3 years of their primary THA implantation.
Exclusion Criteria:
1. Implanted with non-MPO or non-WMT components (femoral heads, acetabular shells, acetabular liners)
2. Skeletally immature (less than 21 years of age) at time of implantation
3. Has or had an overt infection at the time of implantation
4. Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation
5. Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation
6. Has or had 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
7. Has or had neuropathic joints
8. Has or had hepatitis or HIV infection
9. Has or had a neurological or musculoskeletal disease that may adversely affect gait or weight-bearing
10. Has had a revision procedure(s) where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques
11. Currently enrolled in another clinical investigation which could affect the endpoints of this protocol
12. Unwilling or unable to sign the Informed Consent document
13. Has documented substance abuse issue
14. Has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study
15. Currently incarcerated or has impending incarceration
16. Has a medical condition, as judged by the investigator, that would interfere with the subject's ability to comply with the requirements of the protocol -
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT04147559
Study Brief:
Protocol Section:
NCT04147559