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

• Conditions: Joint Disease
• Interventions: Device: PROFEMUR® Z Revision Femoral Stem

• Registration Number: NCT04064008
• Lead Sponsor: MicroPort Orthopedics Inc.

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 Timeline

• Study Start: 2019-04-04
• Study First Submitted: 2019-05-18
• Study First Submitted QC: 2019-08-19
• Study First Posted: 2019-08-21
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-13
• Last Update Posted: 2023-11-14
• Primary Completion: 2030-04
• Study Completion: 2030-04

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Primary Total Hip Arthroplasty	PROFEMUR® Z Revision Femoral Stem	Single study group from a single site previously implanted with the PROFEMUR® Z Revision Femoral Stem

Primary Outcome Measures

Name	Time	Method
Survivorship of ProFemur Z Stem out to 10 years	10 years.	Kaplan-Meier survivorship at specific intervals out to 10 years follow up

Secondary Outcome Measures

Name	Time	Method
to characterize total functional scores for subjects, as assessed by Oxford Hip Scores	2-5 years, 5-7 years, and 10 years.	The study will be reporting the final Oxford Hip score, which is a summary over 12 items. Each of these items is 5-level Likert scale such as from 'not at all' to 'totally'.
Revision rate of the Profemur Z stem out to 10 years	2-5 years, 5-7 years, and 10 years.	Cummulative revision rate at early (2-5yrs), midterm (5-7 year) and long-term (10 year) follow up.

Trial Locations

Locations (1)

Samodzielny Publiczny Szpital Kliniczny Klinika; 🇵🇱 Otwock, Poland