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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-04

Study Completion Date

2030-04-30

Brief Summary

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Single center, prospective follow-up of previously implanted subjects

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Detailed Description

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

Conditions

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Joint Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Primary Total Hip Arthroplasty

Single study group from a single site previously implanted with the PROFEMUR® Z Revision Femoral Stem

PROFEMUR® Z Revision Femoral Stem

Intervention Type DEVICE

Total Hip Total Hip Arthroscopy

Interventions

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PROFEMUR® Z Revision Femoral Stem

Total Hip Total Hip Arthroscopy

Intervention Type DEVICE

Eligibility Criteria

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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,

Exclusion Criteria

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.

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No