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Post Market Clinical Follow-Up Study Protocol for PROFEMUR® L Revision Femoral Stems
Sponsor: MicroPort Orthopedics Inc.
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.
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
OBSERVATIONAL
Enrollment
26
Start Date
2015-09-04
Completion Date
2027-10
Last Updated
2022-10-13
Healthy Volunteers
No
Conditions
Interventions
PROFEMUR® L Revision Femoral Stem
Revision Total Hip Arthroplasty
Locations (1)
Royal Cornwall Hospital
Truro, Cornwall, United Kingdom