TinT10
Research type
Research Study
Full title
Titanium Ions levels in modular titanium acetabular systems with 10 year follow up
IRAS ID
327340
Contact name
Julie Steen
Contact email
Sponsor organisation
The Robert Jones & Agnes Hunt Orthopaedic Hospital Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 31 days
Research summary
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 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.
Whilst elevated titanium ions (>3ng/ml) are not known to be toxic, they may reflect implant failure. Our hypothesis is that the increase in the number of interfaces which gives us the flexibility we need, may increase the potential points of failure as well as increase the release of titanium ions in the blood stream. 140 patients have been identified as having had this modular acetabular system implanted at the RJAH in 2012 & 2013. The aim of this study is to therefore identify the survivorship of these implants at 10 years and whether there is any association between the number of articulations and serum titanium ions or more rapid implant failure.REC name
London - Bloomsbury Research Ethics Committee
REC reference
24/LO/0646
Date of REC Opinion
15 Oct 2024
REC opinion
Further Information Unfavourable Opinion