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

Joint Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04064008
• Other study ID #: 12-LJH-002M
• Status: Enrolling by invitation
• Start date: April 4, 2019
• Est. completion date: April 2030

Study information

• Verified date: November 2023
• Source: MicroPort Orthopedics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Single center, prospective follow-up of previously implanted subjects

Description:

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 30
• Est. completion date: April 2030
• Est. primary completion date: April 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Joint Disease
• Joint Diseases

Intervention

Device:
• PROFEMUR® Z Revision Femoral Stem
Total Hip Total Hip Arthroscopy

Locations

Country	Name	City	State
Poland	Samodzielny Publiczny Szpital Kliniczny Klinika	Otwock

Sponsors (1)

Lead Sponsor	Collaborator
MicroPort Orthopedics Inc.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.
Primary	Survivorship of ProFemur Z Stem out to 10 years	Kaplan-Meier survivorship at specific intervals out to 10 years follow up	10 years.
Secondary	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.
Secondary	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.