Long Term Follow up of the Titanium Modular Revision Hip System, With Review of Metal Ion Levels (TinT10)

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 2013, a minimum of 10 years since hip surgery. They will be x-rayed (AP pelvis and a lateral view) and a blood test will be taken and sent to a lab in Surrey to check titanium levels.

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. 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 Revision TT, Delta One TT and Delta Multihole 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). Through research, it is widely known that when metals interact within the body, they can cause wear and shedding of metal debris. This process is known as metallosis and can result in metal ions being released into the surrounding bone and tissues as well as being absorbed into the blood stream.

The risk of this is highest when there is significant movement between the components (such as in metal-on-metal hip replacements). It is less of an issue at other interfaces which are not intended to allow movement between them. That said, our hypothesis is that the increase in the number of interfaces which gives us the flexibility we need, may increase the release of free metal ions in the blood stream. The aim of this study is to therefore identify if this is in fact the case and if so, whether the increase in ions is sufficient for surgeons to bear in mind.

• 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 2012 and 2013.

Description

Inclusion Criteria:

All adult patients who had Lima Corporate modular titanium acetabular component implants implanted between 2012 and 2013.

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; A sample of blood will be taken and sent to a lab in Surrey to check for metal ions.; Other Names: blood sample

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	By looking at titanium ion blood levels and pelvis x-rays, this gives an indication of whether the device is loosening and failing in this particular hip system.	Once blood results are back from the specialist assessment laboratory (approximately 3 weeks post clinic visit).

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): May 30, 2024
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): May 30, 2025

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 10, 2024
• Last Update Submitted That Met QC Criteria: April 9, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: version 1 27/6/2023

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