Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518993
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-07-15
Brief Title:
Observational Study to Collect Safety Data and PROMs on Primary THA
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Observational Study to Collect Safety Data and Patient-reported Outcomes Measures PROMs on Retrospective Primary Total Hip Arthroplasty Surgeries With Trinity Cup and Meije Duo Cementless Hip Stem
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
This observational study is designed to collect safety data and PROMs on retrospective primary total hipa arthroplasty surgeries with Trinity cup and Meije Duo cementless hip system
Detailed Description:
The major goal of this study is to collect safety and patient-reported outcomes measures PROMs data on Trinity cup in combination with Meije Duo cementless hip stem when used in primary total hip arthroplasty THA
Data collected from this study will be fed into the Post-Market Surveillance PMS and Clinical Evaluation processes of the devices under assessment annually and support presentations at orthopaedic congresses andor peer-reviewed publications on mid- and long-term safety and clinical performance
Data collected from this study will be fed into the Post-Market Surveillance PMS and Clinical Evaluation processes of the devices under assessment annually and support presentations at orthopaedic congresses andor peer-reviewed publications on mid- and long-term safety and clinical performance
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