Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Z Revision Femoral Stems

Launched by MICROPORT ORTHOPEDICS INC. · Aug 19, 2019

Keywords

ClinConnect Summary

Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Z Revision Femoral Stems

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Has undergone a revision for nonunion and/or hardware removal (i.e. all conditions resulting in poor quality proximal bone).
• • 2. Subject is implanted with the PROFEMUR® Z Revision Femoral Stem at the time of their revision THA.
• • 3. Subject is willing and able to complete required study visits or assessments.
• • 4. Plans to be available through the 10 year postoperative follow-up visit.
• Previously implanted bilateral subjects can have both THAs enrolled in the study provided:
• • 1. the PROFEMUR Z Revision Femoral Stem was implanted in both,
• • 2. all other aspects of the Inclusion/Exclusion Criteria are satisfied,
• • 3. enrollment does not exceed the subject count specified in the Clinical Trial Agreement, and
• • 4. the subject agrees to a second Informed Consent document specific to the second THA. Prospective enrollment of a previously unimplanted hip is not permitted in this study.
• Exclusion Criteria:
• • 1. Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol.
• • 2. Subject has a PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254 implanted in the enrolled THA.
• • 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. Subjects unwilling to sign the Informed Consent document.
• • 8. Subjects with substance abuse issues.
• • 9. Subjects with an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study.
• • 10. Subjects who are incarcerated or have pending incarceration.