Ignite Creation Date:
2025-12-24 @ 5:28 PM
Ignite Modification Date:
2025-12-28 @ 5:57 PM
Study NCT ID:
NCT01257568
Status:
COMPLETED
Last Update Posted:
2022-02-16
First Post:
2010-12-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Rejuvenate Modular Outcomes Study
Sponsor:
Stryker Orthopaedics
Organization:
Study Overview
Official Title:
A Prospective, Post-market, Multi-center Study of the Outcomes of the Rejuvenate® Modular Hip System
Status:
COMPLETED
Status Verified Date:
2022-02
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:
This study will be an evaluation of the Rejuvenate® Modular Hip System for primary total hip replacement (THR) with a cementless application in a consecutive series of patients who meet the eligibility criteria. Subjects will be evaluated for freedom of hip revision at 5 years and clinical outcomes for up to 10 years after surgery.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: