Status:
ENROLLING_BY_INVITATION
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Z Revision Femoral Stems
Lead Sponsor:
MicroPort Orthopedics Inc.
Conditions:
Joint Disease
Eligibility:
All Genders
Brief Summary
Single center, prospective follow-up of previously implanted subjects
Detailed Description
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Z Revision Femoral Stems
Eligibility Criteria
Inclusion
- Has undergone a revision for nonunion and/or hardware removal (i.e. all conditions resulting in poor quality proximal bone).
- Subject is implanted with the PROFEMUR® Z Revision Femoral Stem at the time of their revision THA.
- Subject is willing and able to complete required study visits or assessments.
- 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:
- the PROFEMUR Z Revision Femoral Stem was 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, and
- 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
- Subjects currently enrolled in another clinical study which could affect the endpoints of this protocol.
- Subject has a PROFEMUR Neck Varus/Valgus CoCr 8 Degree, Part number PHAC 1254 implanted in the enrolled THA.
- Has or had an overt infection at the time of implantation.
- Has or had a distant foci of infections (which may cause hematogenous spread to the implant site) at the time of implantation.
- Has or had a rapid disease progression as manifested by joint destruction or bone absorption apparent on roentgenogram at the time of implantation.
- 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.
- Subjects unwilling to sign the Informed Consent document.
- Subjects with substance abuse issues.
- Subjects with an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study.
- Subjects who are incarcerated or have pending incarceration.
Key Trial Info
Start Date :
April 4 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
April 1 2030
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04064008
Start Date
April 4 2019
End Date
April 1 2030
Last Update
November 14 2023
Active Locations (1)
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1
Samodzielny Publiczny Szpital Kliniczny Klinika
Otwock, Poland, 05-400