Clinical Trial

Post Market Clinical Follow-Up Study Protocol for PROFEMUR® TL Modular Femoral Stems

Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
Sponsor is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) marketed in the European Union (EU) . These types of studies are required by regulatory authorities for all THA devices that do not have clinical evidence available at the time of gaining approval to market in the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.
Protocol Amendment History 15 amendments
This ClinicalTrials.gov record has been amended 15 times since 2014-09-11; most recent amendment 2023-11-16.
Status change: Enrolling by Invitation → Active, Not Recruiting 2023-11-16
Status change: Recruiting → Enrolling by Invitation 2015-10-16
Status change: Not Yet Recruiting → Recruiting 2014-12-08
Trial Details
NCT Number NCT02239783
Lead Sponsor MicroPort Orthopedics Inc.
Conditions Joint Disease
Enrollment 143 participants
Start Date 2014-11
Primary Completion 2027-11 (estimated)
Study Completion 2028-11 (estimated)
Updated on ClinicalTrials.gov 2023-11-18