Long Term Follow up of the Titanium Modular Revision Hip System up (TinT 10) Levels

Not yet recruiting

• Conditions: Hip Surgery
• Interventions: Radiation: x-ray

• Registration Number: NCT06033651
• Lead Sponsor: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

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.

Study Timeline

• Study First Submitted: 2023-08-29
• Study First Submitted QC: 2023-09-11
• Study First Posted: 2023-09-13
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-09
• Study Start: 2025-04-10
• Primary Completion: 2026-05-14
• Study Completion: 2026-05-14

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

All adult patients who had Lima Corporate modular titanium acetabular component implants implanted between 2011 and 2015.

Exclusion Criteria

Deceased patients Patients who have undergone a subsequent acetabular revision Patients that lack capacity Prisoners in the custody of HM Prison service or who are offenders supervised by the probation service in England or Wales.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Only 1 arm for the study	x-ray	All participants shall receive the same treatment.

Primary Outcome Measures

Name	Time	Method
The survivourship of the modular acetabular hip system at 10 years post-op	Participants will be invited to attend a one time clinic visit, after which their participation in the study has ended.	This study will be the largest study to look at the survivorship of this acetabular system. Survivorship will be to the point of revision and clinical outcome survivorship is to the point of radiological loosening and PROMs data collection.