Post Market Clinical Follow‐Up Study Protocol for PROFEMUR® Z Revision Femoral Stems
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|ClinicalTrials.gov Identifier: NCT04064008|
Recruitment Status : Recruiting
First Posted : August 21, 2019
Last Update Posted : October 21, 2019
|Condition or disease||Intervention/treatment|
|Joint Disease||Device: PROFEMUR® Z Revision Femoral Stem|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Post Market Clinical Follow‐Up Study Protocol for PROFEMUR® Z Revision Femoral Stems|
|Actual Study Start Date :||April 4, 2019|
|Estimated Primary Completion Date :||April 2030|
|Estimated Study Completion Date :||April 2030|
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
- 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
- Revision rate of the Profemur Z stem out to 10 years [ Time Frame: 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.
- to characterize total functional scores for subjects, as assessed by Oxford Hip Scores [ Time Frame: 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'.
- to characterize total functional scores for subjects, as assessed by EQ‐5D‐3L scores. [ Time Frame: 2-5 years, 5-7 years, and 10 years. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064008
|Contact: Cagla Yazici, MS||+31 20 545 email@example.com|
|Contact: Karen Martin, RN, BSN, MBA||901-867-4712||Karen.Martin@ortho.microport.com|
|Samodzielny Publiczny Szpital Kliniczny Klinika||Recruiting|
|Otwock, Poland, 05-400|
|Contact: Jerzy Bialecki, MD|
|Principal Investigator:||Jerzy Bialecki, Dr.||Samodzielny Publiczny Szpital Kliniczny Klinika|