Clinical Trial

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

Active, Not Recruiting
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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.
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2019-03-04; most recent amendment 2023-04-26.
Status change: Recruiting → Active, Not Recruiting 2022-04-21
Trial Details
NCT Number NCT03865667
Lead Sponsor MicroPort Orthopedics Inc.
Conditions Joint Disease
Enrollment 63 participants
Start Date 2019-01-15
Primary Completion 2032-01-01 (estimated)
Study Completion 2032-01-01 (estimated)
Updated on ClinicalTrials.gov 2023-04-28