Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT06033651
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-09
First Post:
2023-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Long Term Follow up of the Titanium Modular Revision Hip System up (TinT 10) Levels
Sponsor:
Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
Organization:
Study Overview
Official Title:
Long Term Follow up of the Titanium Modular Revision Hip System up (TinT 10)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-04
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:
TinT10
Brief Summary:
Patients are to be approached to attend clinic who have been identified as being implanted with either a Lima Corporate Delta Revision TT, Delta One TT or the Delta Multihole Systems hip systems between 2011 and 2015, a minimum of 10 years since hip surgery. They will be x-rayed (AP pelvis and a lateral view) and have a clinical review in clinic.
Detailed Description:
Since its popularisation in the 1960's, Hip replacements have become one of the NHS's highest volume procedures. Unfortunately, hip replacements can fail with on average 8,500 revision hip replacements being performed each year pre-covid(1). Often this is very complex with destruction of the normal anatomy leaving surgeons with a significant challenge in ensuring appropriate positioning of the socket within the confines of the patient's anatomy.
The Lima Corporate Delta systems are designed to help surgeons with this very problem by providing the option of a 'face changer' allowing surgeons to place a socket within a socket.
To allow for this function, the 'face changer' must connect with the acetabular cup (socket).
140 patients have been identified as having had this modular acetabular system implanted at the RJAH in 2012 \& 2014, going into 2015. The aim of this study is to therefore identify the survivorship of these implants at 10 years.
The Lima Corporate Delta systems are designed to help surgeons with this very problem by providing the option of a 'face changer' allowing surgeons to place a socket within a socket.
To allow for this function, the 'face changer' must connect with the acetabular cup (socket).
140 patients have been identified as having had this modular acetabular system implanted at the RJAH in 2012 \& 2014, going into 2015. The aim of this study is to therefore identify the survivorship of these implants at 10 years.
Study Oversight
Has Oversight DMC:
False
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?: