OINEURO
Research type
Research Study
Full title
Can orthopaedic implants cause systemic adverse effects?
IRAS ID
236498
Contact name
Alister Hart
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2018/04/21, UCL Data Protection Registration
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Orthopaedic joint replacement leads to significant improvements in quality of life in patients with end-stage osteoarthritis. Implants made of cobalt-chromium alloy are popular due to their strength and durability. However, friction between bearing surfaces and corrosion of non-moving parts can result in increased concentration of cobalt and chromium in the blood and tissues. Some patients exposed to high circulating concentrations of cobalt develop systemic adverse effects such as heart dysfunction, hearing/visual changes, thyroid abnormalities and/or skin changes, which may be reversible with a timely removal of the offending prosthesis. Currently, there is no universally accepted threshold level above which blood concentrations of cobalt are likely to lead to systemic toxicity. Even though majority of the affected patients displayed extremely high cobalt concentrations, mild increases in serum cobalt were reported to cause a range of neurological symptoms in some patients. It is possible that systemic sequelae are unreported in the hundreds of thousands of patients who currently harbor an orthopaedic prosthesis.
We seek to recruit adult joint replacement patients who have been exposed to elevated blood cobalt levels, to carry out a study of potential systemic manifestations. Neurological and psychiatric symptoms will be assessed with a set of questionnaires. A group of patients with normal blood cobalt (<1 µg/L) will undergo the same investigation and thus serve as a control in the study.
The study, which is expected to take 1 year to complete, will be in fulfilment of Miss Ilona Swiatkowska's PhD project.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
18/YH/0245
Date of REC Opinion
5 Jul 2018
REC opinion
Further Information Favourable Opinion