NCT04064008Enrolling By InvitationNot Applicable
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Z Revision Femoral Stems
MicroPort Orthopedics Inc.1 site in 1 country30 target enrollmentStarted: April 4, 2019Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- MicroPort Orthopedics Inc.
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Survivorship of ProFemur Z Stem out to 10 years
Study Overview
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Survivorship of ProFemur Z Stem out to 10 years
Time Frame: 10 years.
Kaplan-Meier survivorship at specific intervals out to 10 years follow up
Secondary Outcomes
- to characterize total functional scores for subjects, as assessed by Oxford Hip Scores(2-5 years, 5-7 years, and 10 years.)
- Revision rate of the Profemur Z stem out to 10 years(2-5 years, 5-7 years, and 10 years.)
Investigators
Study Sites (1)
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