Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2025-12-25 @ 5:24 PM
Study NCT ID:
NCT04425603
Status:
COMPLETED
Last Update Posted:
2022-09-30
First Post:
2020-01-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anthology Hip Replacement System - Orthopaedic Data Evolution Panel (ODEP) Surveillance Study
Sponsor:
Smith & Nephew Orthopaedics AG
Organization:
Study Overview
Official Title:
Anthology Hip Replacement System - Orthopaedic Data Evolution Panel (ODEP) Surveillance Study
Status:
COMPLETED
Status Verified Date:
2022-09
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:
This clinical study will verify the clinical and radiographic performance of the prosthesis when used in human subjects over a period of 10 years. All complications will be documented.
Detailed Description:
The clinical evaluations will be based on standard, functional and pain parameters Harris Hip Score pre-operatively, and at 6 months, 3, 5, 7.5 and 10 years post-operatively. Postal Oxford questionnaire preoperatively, and yearly thereafter. The objective of this study is to analyse the clinical and radiographic responses and the complication rates for patients undergoing primary total hip arthroplasty using the Anthology Hip Replacement System (Anthology Hip System).
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?: