Long Term Follow up of the Titanium Modular Revision Hip System up (TinT 10) Levels (TinT10)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hip Surgery
• Intervention / Treatment: Radiation: x-ray

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Julie Steen; Phone Number: 4418 +441691404418; Email: julie.steen@nhs.net
• Study Contact Backup: Name: Thomas Banks; Phone Number: +441691404418; Email: thomas.banks3@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Only 1 arm for the study; All participants shall receive the same treatment.	Radiation: x-ray; AP view of pelvis; Other Names: AP view of pelvis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The survivourship of the modular acetabular hip system at 10 years post-op	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.	Participants will be invited to attend a one time clinic visit, after which their participation in the study has ended.

Collaborators and Investigators

• Sponsor: Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust
• Investigators: Principal Investigator: Robin Banerjee, The Robert Jones and Agnes Hunt Orthopaedic Hospital Foundation Trust

Publications and helpful links

General Publications

• Ben-Shlomo Y, Blom A, Boulton C, Brittain R, Clark E, Dawson-Bowling S, Deere K, Esler C, Espinoza O, Evans J, Goldberg A, Gregson C, Howard P, Jameson S, Jennison T, Judge A, Lawrence S, Lenguerrand E, Marques E, McCormack V, Newell C, Pegg D, Penfold C, Porter M, Price A, Reed M, Rees J, Royall M, Sayers A, Stonadge J, Swanson M, Taylor D, Toms A, Watts A, Whitehouse M, Wilkinson M, Wilton T, Young E. The National Joint Registry 19th Annual Report 2022 [Internet]. London: National Joint Registry; 2022 Oct. Available from http://www.ncbi.nlm.nih.gov/books/NBK587525/
• Liu TK, Liu SH, Chang CH, Yang RS. Concentration of metal elements in the blood and urine in the patients with cementless total knee arthroplasty. Tohoku J Exp Med. 1998 Aug;185(4):253-62. doi: 10.1620/tjem.185.253.

Study record dates

Study Major Dates

• Study Start (Estimated): April 10, 2025
• Primary Completion (Estimated): May 14, 2026
• Study Completion (Estimated): May 14, 2026

Study Registration Dates

• First Submitted: August 29, 2023
• First Submitted That Met QC Criteria: September 11, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): April 9, 2025
• Last Update Submitted That Met QC Criteria: April 7, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: RL1 879

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No