Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06153940
Status:
RECRUITING
Last Update Posted:
2023-12-01
First Post:
2023-11-22
Brief Title:
Everglade Stem World Cup and World Liner Post Market Clinical Follow-up
Sponsor:
Signature Orthopaedics
Organization:
Signature Orthopaedics
Study Overview
Official Title:
Everglade Stem World Cup and World Liner Post Market Clinical Follow-up
Status:
RECRUITING
Status Verified Date:
2023-11
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 Everglade Stem World Acetabular Cup and World Liner as a part of post-market vigilance and continuous improvement efforts
Detailed Description:
The Objective of this Post market Clinical Follow up PMCF study is to collect data confirming safety performance and clinical benefits of the Everglade Stem World Acetabular Cup and World Liner when used for a primary total hip arthroplasty at 2 years follow-up
This prospective follow-up series is necessary to gather data for the Everglade Stem World Acetabular Cup and World Liner as they are recently launched to the market
The data concerning the performance and safety of the devices are gathered in various time frames starting with pre-operative status and then includes operative at discharge i year post-operative and 2 year post-operative evaluations
The revision rate of the components will be monitored as the primary objective along with pre- and post-operative measurement of the Oxford Hip ScoreOHS patient-reported outcome measurePROM to quantify patient satisfaction and radiographic analysis to monitor the bony response to the implants and quantify the effectiveness of the cementless fixation
This prospective follow-up series is necessary to gather data for the Everglade Stem World Acetabular Cup and World Liner as they are recently launched to the market
The data concerning the performance and safety of the devices are gathered in various time frames starting with pre-operative status and then includes operative at discharge i year post-operative and 2 year post-operative evaluations
The revision rate of the components will be monitored as the primary objective along with pre- and post-operative measurement of the Oxford Hip ScoreOHS patient-reported outcome measurePROM to quantify patient satisfaction and radiographic analysis to monitor the bony response to the implants and quantify the effectiveness of the cementless fixation
Study Oversight
Has Oversight DMC:
None
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?:
False
Is an FDA AA801 Violation?:
None