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

Single center, prospective follow-up of previously implanted subjects

Study Overview

• Status: Enrolling by invitation
• Conditions: Joint Disease
• Intervention / Treatment: Device: PROFEMUR® Z Revision Femoral Stem

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

Study Locations

• Poland
  • Otwock, Poland, 05-400
    • Samodzielny Publiczny Szpital Kliniczny Klinika

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Primary Total Hip Arthroplasty; Single study group from a single site previously implanted with the PROFEMUR® Z Revision Femoral Stem	Device: PROFEMUR® Z Revision Femoral Stem; Total Hip Total Hip Arthroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survivorship of ProFemur Z Stem out to 10 years	Kaplan-Meier survivorship at specific intervals out to 10 years follow up	10 years.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Revision rate of the Profemur Z stem out to 10 years	Cummulative revision rate at early (2-5yrs), midterm (5-7 year) and long-term (10 year) follow up.	2-5 years, 5-7 years, and 10 years.
to characterize total functional scores for subjects, as assessed by Oxford Hip Scores	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'.	2-5 years, 5-7 years, and 10 years.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
to characterize total functional scores for subjects, as assessed by EQ-5D-3L scores.	EQ-5D-3L data will be summarized over 5 domains, namely, mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each domain has 3 levels: no problems, some problems, and extreme problems.	2-5 years, 5-7 years, and 10 years.

Collaborators and Investigators

• Sponsor: MicroPort Orthopedics Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2019
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: May 18, 2019
• First Submitted That Met QC Criteria: August 19, 2019
• First Posted (Actual): August 21, 2019

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 13, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Joint Diseases
• Other Study ID Numbers: 12-LJH-002M

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No