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Post Market Clinical Follow-Up Study Protocol for CONSERVE® Press-Fit Femoral Components
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
143
Start Date
2014-12
Completion Date
2028-12
Last Updated
2023-06-07
Healthy Volunteers
No
Conditions
Interventions
Primary hip resurfacing device
CONSERVE® Press-Fit Femoral Components
Locations (1)
Ottawa Hospital
Ottawa, Ontario, Canada