Silver ion analysis of silver coated endoprosthesis
Research type
Research Study
Full title
Elution characteristics of silver coated endoprosthesis
IRAS ID
152798
Contact name
Robert Grimer
Contact email
Sponsor organisation
The Royal Orthopaedic Hospital
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
Background: Limb salvage surgery using an internal implant (i.e. an endoprosthesis) to replace the diseased bone has significantly improved the care of patients with bone cancer. However, limb salvage using a metal implant carries a risk of infection that may lead to further surgery or even amputation. Antibacterial silver-coating of implants is known to be a safe and effective method for preventing infection. Yet little is known about the levels of silver within the joint and the duration of the protective effect against infection.
Purpose: The purpose of this study is to assess the levels of silver in joint fluid and blood after surgery in bone cancer patients who were given a silver-coated metal implant to replace bone that was removed with the tumour.
Methods: A total of 30 bone cancer patients treated with a silver-coated metal implant at the Royal Orthopaedic Hospital (ROH) in Birmingham will be included in the study. Samples of joint fluid will be collected up to 7 days after surgery from a drain that is routinely placed into the joint. Blood samples will be collected before surgery, during hospital stay, and at 6 weeks, 3 months, 6 months, 9 months, and 1 year after surgery. Joint fluid will be examined to assess the levels of silver within the joint cavity where it acts as an antibacterial agent. Silver concentrations in the blood will be measured to assess the duration of silver release and the effects of silver in blood, bone, liver and kidneys.
Outcomes: This study will help us to establish the levels, peak and duration of the protective effect of silver against infection, and to observe the effects of silver in blood, bone, liver and kidneys. Recommendations will be made concerning the care and follow-up of bone cancer patients as part of standard practice.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
14/SW/1174
Date of REC Opinion
19 Jan 2015
REC opinion
Further Information Favourable Opinion