Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06632301
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-07
Brief Title:
DEXA Bone Density Analysis of the CoreHip Prosthesis System
Sponsor:
None
Organization:
None
Study Overview
Official Title:
DEXA Bone Density Analysis to Analyze the Loading Concept of the CoreHip Prosthesis
Status:
NOT_YET_RECRUITING
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:
CODEX
Brief Summary:
The goal of this interventional post-market follow-up study is to evaluate radiological changes in the diaphyseal bone density Gruen Zones 3 and 4 within 24 months postoperative in patients treated with CoreHip primary cementless stem The DEXA bone density analysis is used
Detailed Description:
Additional diagnostic examination DEXA-Analysis A DEXA scan is an imaging test that measures bone density strength The results can provide helpful details about risk for osteoporosis bone loss and fractures Furthermore we would like to find out more about stress shielding processes around our prosthesis
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