Ignite Creation Date:
2025-12-24 @ 2:52 PM
Ignite Modification Date:
2026-01-31 @ 5:03 AM
Study NCT ID:
NCT04147559
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-20
First Post:
2019-10-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post Market Clinical Follow-Up Study for PROFEMUR® Preserve Classic Femoral Stem
Sponsor:
MicroPort Orthopedics Inc.
Organization:
Study Overview
Official Title:
Post Market Clinical Follow-Up Study for PROFEMUR® Preserve Classic Femoral Stem
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: