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Post Market Clinical Follow-Up Study Protocol for PROFEMUR® Preserve Femoral Stem
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.
Details
| Lead sponsor | MicroPort Orthopedics Inc. |
|---|---|
| Status | ACTIVE_NOT_RECRUITING |
| Enrolment | 63 |
| Start date | Tue Jan 15 2019 00:00:00 GMT+0000 (Coordinated Universal Time) |
| Completion | Thu Jan 01 2032 00:00:00 GMT+0000 (Coordinated Universal Time) |
Conditions
- Joint Disease
Interventions
- PROFEMUR® Preserve Femoral Stem
Countries
Spain