Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2025-12-24 @ 11:07 PM
Study NCT ID:
NCT06172569
Status:
RECRUITING
Last Update Posted:
2023-12-15
First Post:
2023-12-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Spartan Stem, World Cup and World Liner Post Market Clinical Follow-up Study
Sponsor:
Signature Orthopaedics
Organization:
Study Overview
Official Title:
Spartan Stem, World Cup and World Liner Post Market Clinical Follow-up Study
Status:
RECRUITING
Status Verified Date:
2023-12
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:
The aim of the study is to monitor the performance of the Signature Orthopaedics Spartan Stem, World Acetabular Cup and World Liner as a post-market vigilance and continuous improvement efforts.
Detailed Description:
The objective of this PMCF Study is to collect data confirming safety, performance and clinical benefits of the Spartan Stem, World Acetabular Cup and the World Liner when used for primary total hip arthroplasty at 2-years follow-up.
The study includes pre-operative, operative, discharge, 1 year post-operative evaluations, where data concerning the performance and safety of the device are gathered.
The revision rate of the components will be monitored as the primary objective, along with pre and post operative measurement of the Oxford Hip Score (OHS), patient-reported outcome measure (PROM) to quantify patient satisfaction.
Radiography analysis will be done to monitor bony response to the implant and qualify the effectiveness of the cementless fixation.
The study includes pre-operative, operative, discharge, 1 year post-operative evaluations, where data concerning the performance and safety of the device are gathered.
The revision rate of the components will be monitored as the primary objective, along with pre and post operative measurement of the Oxford Hip Score (OHS), patient-reported outcome measure (PROM) to quantify patient satisfaction.
Radiography analysis will be done to monitor bony response to the implant and qualify the effectiveness of the cementless fixation.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: