Clinical Trial

PMCF Study Protocol for PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components

Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
MicroPort Orthopedics (MPO) is conducting this post market clinical follow-up (PMCF) study to evaluate the safety and efficacy of its total hip arthroplasty (THA) components marketed in the European Union (EU). These types of studies are required by regulatory authorities for all THA 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 the medial device directives (MEDDEV) 2.12/2 rev 2.
Protocol Amendment History 11 amendments
This ClinicalTrials.gov record has been amended 11 times since 2016-07-01; most recent amendment 2022-07-07.
Status change: Enrolling by Invitation → Active, Not Recruiting 2022-07-07
Status change: Recruiting → Enrolling by Invitation 2017-12-18
Status change: Not Yet Recruiting → Recruiting 2017-06-19
Trial Details
NCT Number NCT02823834
Lead Sponsor MicroPort Orthopedics Inc.
Conditions Joint Disease
Enrollment 121 participants
Start Date 2017-06-16
Primary Completion 2027-06 (estimated)
Study Completion 2027-06 (estimated)
Updated on ClinicalTrials.gov 2022-07-08