Clinical Research Directory
Browse clinical research sites, groups, and studies.
PMCF Study Protocol for PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components
Sponsor: MicroPort Orthopedics Inc.
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.
Official title: Post Market Clinical Follow-up Study Protocol for PROFEMUR® Gladiator Plasma Femoral Stems and PROCOTYL® L Beaded Acetabular Components
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
OBSERVATIONAL
Enrollment
121
Start Date
2017-06-16
Completion Date
2027-06
Last Updated
2022-07-08
Healthy Volunteers
No
Conditions
Interventions
PROFEMUR® Gladiator Plasma Femoral Stems
THA using PROFEMUR® Gladiator Plasma stems and PROCOTYL® L Beaded Acetabular Components
Locations (1)
Elbe Kliniken Buxtehude
Buxtehude, Germany