RCT comparing bioabsorbable screws against metal screws, V1
Research type
Research Study
Full title
Randomised control trial comparing Magnezix bioabsorbable screws and pins with titanium/metal screws and pins for bone fixation in fracture or Osteotomy
IRAS ID
242910
Contact name
Sanjeev Madan
Contact email
Sponsor organisation
Sheffield Childrens Hospital
Duration of Study in the UK
0 years, 9 months, 30 days
Research summary
This study will look into the effectiveness of a new material for screws and pins which are used in bone fixation for repair of fractures or in osteotomy, comparing it to what is currently in use. Bone fixation is the process by which a fragment of bone can be attached or re-attached to another bone, in order for it to heal properly, using screws and pins to hold it in place. The material currently used in these is a metallic alloy, which is then either removed at a later date or left in the bone permanently. The permanent implantation of a screw can lead to complications in the future at the site of the screw or pin such as inflammatory or allergic conditions. The new material being compared in this trial is made up of a biodegradable magnesium compound, this means that, once it is implanted in the body, it will slowly begin to biodegrade and eventually disappear, with new bone growing over the space left. This removes the chance of complications associated with foreign objects in the person’s body in later years.
This trial will take place at Sheffield Childrens hospital and Doncaster Royal Infirmary. The trial involves 60 paediatric patients who require surgery for intra-articular bone fixation. Participants will be split into 2 even sized groups which were randomly assigned to them. Each group will either receive the Magnezix© bioabsorbale screws/pins or receive the metallic screws/pins that are currently in use at these hospitals. The patients will undergo regular follow up for 2 months after the procedure to assess and score the outcomes of the surgery.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
18/LO/1725
Date of REC Opinion
11 Oct 2018
REC opinion
Unfavourable Opinion