Clinical Trial

Post Market Clinical Follow-up Study Protocol for DYNASTY® BioFoam® Acetabular Components

Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
Sponsor 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 the EU. This study has been designed in accordance with MEDDEV 2.12/2 rev 2.
Protocol Amendment History 16 amendments
This ClinicalTrials.gov record has been amended 16 times since 2014-05-23; most recent amendment 2023-06-06.
Status change: Enrolling by Invitation → Active, Not Recruiting 2022-04-05
Status change: Recruiting → Enrolling by Invitation 2015-10-16
Status change: Not Yet Recruiting → Recruiting 2015-01-06
Trial Details
NCT Number NCT02149667
Lead Sponsor MicroPort Orthopedics Inc.
Conditions Joint Disease
Enrollment 48 participants
Start Date 2014-12
Primary Completion 2027-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2023-06-07