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

R

Robert Jones and Agnes Hunt Orthopaedic and District NHS Trust

Status

Not yet enrolling

Conditions

Hip Surgery

Treatments

Radiation: x-ray

Study type

Observational

Funder types

Other

Identifiers

NCT06033651
version 1 27/6/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Only 1 arm for the study
Description:
All participants shall receive the same treatment.
Treatment:
Radiation: x-ray

Trial contacts and locations

0

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Central trial contact

Thomas Banks; Julie Steen

Data sourced from clinicaltrials.gov

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