Chromium ion levels in patients undergoing spinal deformity surgery
Research type
Research Study
Full title
Chromium ion levels in patients undergoing spinal deformity surgery. A cross sectional pilot study.
IRAS ID
164013
Contact name
Almas Khan
Contact email
Sponsor organisation
Leeds Teaching Hospitals NHS Trust
Duration of Study in the UK
0 years, 3 months, 0 days
Research summary
Surgery for the treatment of spinal deformity (Scoliosis and Kyphosis) involves correction of the deformity and surgical fusion (arthrodesis) using metal alloy implants, which remain inside the body for the duration of the patient’s life. Metal alloy implants have been used in spinal deformity surgery for a number of years, although the long-term effect of retention of spinal metalwork is unclear. One of the main issues concerning metal prostheses elsewhere in the body is the potential for an inflammatory or systemic response to metal degradation products. The microscopic breakdown of the metal prosthesis may act to threaten the structural integrity of the implant and may cause local or systemic toxicity. Raised blood (serum) metal ion levels have been linked to harmful health effects including possible increases in the risk of cancer and problems during pregnancy. There is currently very little information available about the effect of spinal implants on the levels of metal ions in the blood. This is a pilot study to determine the serum metal ion levels of patients undergoing sugary to correct spinal deformity. Patients aged 11-40 with a diagnosis of Scoliosis or Kyphosis will be identified through clinic lists and inpatient attendances. This will include pre-operative assessment and postoperative follow-up. Patients consenting to be involved in the study will give a single blood sample which will be tested for serum chromium and cobalt levels. A total of 100 samples will be taken - equating to an estimated three months of data collection. Information from this study will identify the timescale of any changes in serum metal ion levels and help to plan for future research projects.
REC name
West of Scotland REC 5
REC reference
14/WS/1115
Date of REC Opinion
22 Oct 2014
REC opinion
Unfavourable Opinion