Post Market Clinical Follow-Up Study for PROFEMUR® Preserve Classic Femoral Stem

Launched by MICROPORT ORTHOPEDICS INC. · Oct 29, 2019

Keywords

ClinConnect Summary

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Gender

ALL

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 -