MIC MAGEC
Research type
Research Study
Full title
Analysis of metal ion content in the blood of patients with MAGEC growth rod insertion
IRAS ID
194702
Contact name
Wai Weng Yoon
Contact email
Sponsor organisation
Royal National Orthopaedic Hospital Trust
Duration of Study in the UK
0 years, 3 months, 19 days
Research summary
Early onset scoliosis is a spinal deformity, which usually commences before the age of 5 and as it progresses it has a significant impact on the health of the suffer. Spinal rods are used to correct the deformity and straighten the patients spine. In recent years through development of technology magnetic growth rods have been used. Their use is quite revolutionary in treating scoliosis patients, as their use allows patient to attend outpatients clinics to extend the length of the inserted rod. This is a huge improvement to standard growth rods where re-operation is required to allow for growing of the patient (child). The magnetic growth rods began to be used in 2009, and at RNOH alone over 60 paediatric patients have been treated.
In recent years, evidence has shown that continuous monitoring of patients is required for specific types of implants. We know from the work undertaken in hip replacements as well as other orthopaedic implants that some implant wear debris is anticipated. However, other spinal rods get removed or replaced, this is different for the magnetic rod, which remain in situ for longer periods. The current device is made of titanium alloy, and the rods and the magnetic mechanism are sealed in a specially designed housing system, and not exposed. However, it is important to establish what if any wear debris is present.
As such the proposed study will assess blood serum levels of specific metal ions in patients who have had the implant inserted.
At times the rods need to be removed, should a rod need to be removed during the study patients will be asked if the rod can be retain to determine in more detail why it had to be removed.REC name
East Midlands - Derby Research Ethics Committee
REC reference
15/EM/0556
Date of REC Opinion
7 Jan 2016
REC opinion
Further Information Favourable Opinion