Clinical Trial

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

Enrolling by Invitation
View on ClinicalTrials.gov →
Summary
Sponsor is conducting this post market clinical study to evaluate the safety and effectiveness of its PROFEMUR® Preserve Classic Femoral Stem. This type of study is required by regulatory authorities for all devices that have been approved in Europe (EU) to evaluate the medium and long-term clinical evidence. This study has been designed in accordance with MEDDEV2.12/2 (European Medical Device Vigilance System) rev2 and ISO (International Organization of Standardization) 14155:2011 guidelines.
Protocol Amendment History 9 amendments
This ClinicalTrials.gov record has been amended 9 times since 2019-10-29; most recent amendment 2024-03-19.
Status change: Not Yet Recruiting → Enrolling by Invitation 2020-07-24
Trial Details
NCT Number NCT04147559
Lead Sponsor MicroPort Orthopedics Inc.
Conditions Joint Diseases
Enrollment 150 participants
Start Date 2020-10-21
Primary Completion 2033-05-01 (estimated)
Study Completion 2033-11-01 (estimated)
Updated on ClinicalTrials.gov 2024-03-20