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Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Preserve Femoral Stem

Joint Disease Clinical Trial

Official title:
Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Preserve Femoral Stem

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03865667
Study type Observational
Source MicroPort Orthopedics Inc.
Contact
Status Active, not recruiting
Phase
Start date January 15, 2019
Completion date January 1, 2032
View Details
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