MADER
Research type
Research Study
Full title
Metal ion determination in endoprosthetic replacements
IRAS ID
128396
Contact name
Robert Grimer
Contact email
Sponsor organisation
The Royal Orthopaedic Hospital
Duration of Study in the UK
0 years, 6 months, 1 days
Research summary
Exposure to heavy metal ions Cobalt (Co) and Chromium (Cr) has been shown to cause adverse reactions to the human body, specifically the immune system and kidneys. High levels of Cobalt (Co), Chromium (Cr) and Titanium (Ti) have been reported in the use of surgically implanted metal prostheses, most commonly in metal-on-metal hip replacements. Most of the evidence on metal ions from surgical implants is from standard joint replacements that have been inserted for osteoarthritis and the information that has been gathered has enabled safety guidelines to be put in place.
Metal endoprosthetic replacements (EPR) are commonly used to reconstruct the extremity after removal of a bone tumour. Because of the large amount of metal inserted into the body, there is a potential for metal ions to accumulate within the patient’s body much like typical joint replacements. There is however very little medical evidence about metal ions levels in EPRs. The levels of Co and Cr in EPRs and whether these levels could be causing toxicity are not reliably known.
From studies about metal-on-metal hip replacements, we know that the majority of joint replacements that are working well and not loose commonly have acceptable levels of metal ions. High levels of Co and Cr are usually seen in metal-on-metal joint replacements that are not functioning well or have become loose.
This study aims to establish how high levels of Co, Cr and Ti are in patients with EPRs which have started to loosen or have failed (Revision group) compared to patients with EPRs which do not require maintenance surgery (Stable group). The study will also measure whether signs of toxicity to the kidneys are present.
REC name
West of Scotland REC 4
REC reference
14/WS/1118
Date of REC Opinion
24 Oct 2014
REC opinion
Further Information Favourable Opinion