clinical trial · NCT04147559
Post Market Clinical Follow-Up Study for PROFEMUR® Preserve Classic Femoral Stem
MicroPort Orthopedics Inc.·—·enrolling by invitation·n = 150
Joint DiseasesTotal Hip Arthroplasty Implant
brief 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.
started
Oct 21, 2020
primary completion
May 1, 2033
completion
Nov 1, 2033
last updated
Mar 20, 2024
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol