Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06564636
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
A Multi-Centre Study in Patients Undergoing Total Hip Arthroplasty With the SmithNephew CATALYSTEM Primary Hip System
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Multi-Centre Study in Patients Undergoing Total Hip Arthroplasty With the SmithNephew CATALYSTEM Primary Hip System
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CATALYSTEM
Brief Summary:
A Multi-Center Study in Patients Undergoing Total Hip Arthroplasty with the SmithNephew CATALYSTEM Primary Hip System The purpose of the study is to assess safety and performance of the CATALYSTEM and to support product approval in global markets
Detailed Description:
This study is a multi-center prospective non-randomized study of subjects implanted with the CATALYSTEM Primary Hip System for primary Total Hip Arthroplasty THA Subjects will be enrolled and followed for 5 years post-operatively to assess safety and efficacy of the CATALYSTEM Primary Hip System The primary objective is to assess 2-year post-operative stem survivorship of the CATALYSTEM Hip System ie the femoral stem with all its variants and instrumentation in primary THA procedures for each stem type CollaredCollarless Stem survivorship is defined as no aseptic revision of the implanted femoral stem
Study Oversight
Has Oversight DMC:
None
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?:
None