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Post Market Clinical Follow-Up Study Protocol for PROCOTYL® C 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 Europe. This study has been designed in accordance with the medial device directives (MEDDEV) 2.12/2 rev 2.
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
OBSERVATIONAL
Enrollment
143
Start Date
2019-03-27
Completion Date
2032-12
Last Updated
2023-11-14
Healthy Volunteers
No
Conditions
Interventions
PROCOTYL® C
Hip Arthroplasty
Locations (1)
Elbe Kliniken Buxtehude
Buxtehude, Germany