Clinical Trial

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

Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
MicroPort Orthopedics (MPO) is conducting this PMCF study to evaluate the safety and efficacy of its THA and resurfacing components marketed in the EU. These types of studies are required by regulatory authorities for all THA and resurfacing devices that do not have medium to long-term 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 14 amendments
This ClinicalTrials.gov record has been amended 14 times since 2014-12-08; most recent amendment 2022-10-12.
Status change: Enrolling by Invitation → Active, Not Recruiting 2020-10-22
Status change: Recruiting → Enrolling by Invitation 2017-12-18
Status change: Not Yet Recruiting → Recruiting 2016-03-15
Trial Details
NCT Number NCT02314702
Lead Sponsor MicroPort Orthopedics Inc.
Conditions Joint Disease
Enrollment 26 participants
Start Date 2015-09-04
Primary Completion 2026-10 (estimated)
Study Completion 2027-10 (estimated)
Updated on ClinicalTrials.gov 2022-10-13