Blood Metal Biomarkers of Implant Function
Research type
Research Study
Full title
Blood Metal Biomarkers of Implant Function
IRAS ID
336482
Contact name
Johann Henckel
Contact email
Sponsor organisation
The Royal National Orthopaedic Hospital (RNOH)
Duration of Study in the UK
5 years, 1 months, 1 days
Research summary
This study at the RNOH Implant Science Centre will investigate how much metal is present in blood samples drawn from patients undergoing surgical treatment with metal orthopaedic implants. The aim is to understand if these tests can be used as a biomarker of implant function so as to identify patients with implants beginning to fail. This would inform surgeons of the need for closer monitoring of these patients and/or a change in their clinical management plan to minimise the negative impact of the failing implant.
We will achieve this by establishing (1) how blood metal levels change over time in patients with metal implants and (2) how these levels relate to clinical and implant performance.
This study will recruit patients at participating research hospital sites who, as part of their routine clinical care, are due to undergo surgical treatment with a metal orthopaedic implant as a primary procedure (i.e., for the first time).
A blood sample will be drawn from the patient at a routine clinic visit prior to their operation. Subsequent blood samples will be drawn at normal follow up clinics after the patient receives the implant up to a period of 5 years. If the implant requires revision or removal in this time, a blood sample will be captured at the pre-operative clinic visit and at post-operative clinic visits for up to 1 year after the revision/removal operation.
The blood samples captured at each timepoint will be analysed to quantify any metal ions that may be present. If the implant is removed from the patient, it will be retained for analysis to investigate the association between metal levels and any implant damage.
REC name
West Midlands - Edgbaston Research Ethics Committee
REC reference
24/WM/0138
Date of REC Opinion
25 Jun 2024
REC opinion
Favourable Opinion