Ignite Creation Date:
2024-05-06 @ 6:23 PM
Last Modification Date:
2024-10-26 @ 2:47 PM
Study NCT ID:
NCT05649007
Status:
RECRUITING
Last Update Posted:
2022-12-13
First Post:
2022-12-02
Brief Title:
Post-marketing Surveillance Study of the Saphir Stem in Primary Hip Surgery
Sponsor:
Gruppo Bioimpianti Srl
Organization:
Gruppo Bioimpianti Srl
Study Overview
Official Title:
Post-marketing Surveillance Study of the Saphir Stem in Primary Hip Surgery
Status:
RECRUITING
Status Verified Date:
2022-12
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:
Post-market clinical follow up investigation on the use of saphir stem and FIN Cup or Dualis system in the treatment of pathologies requiring hip arthroplasty The main object of the clinical investigation is the evaluation of long term survival rate of Saphir stem
Detailed Description:
The main object of the clinical investigation is the evaluation of Stem SAPHIR survival rate The post market clinical follow up will also consider as further seconday endpoints improvement of paient function quality of life safety of device intended as possible adverse events related to the use of the prosthesis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None