The Oxford Trauma team conducted a multicentre randomised clinical trial and compared over 300 patients treated with IM nail fixation versus locking plate fixation in the 12 months following a fracture of the distal tibia, also known as the shinbone.
Participants in the Fixation of Distal Tibia Fractures (FixDT) trial showed similar disability ratings at 6 and 12 months, but recovery was faster in the IM nail fixation group with significantly less disability at 3 months.
"Up until our trial, the best treatment for fractures of the distal tibia remained controversial. We are very pleased to be able to contribute an answer to the best form of treatment for these fractures and inform an evidence-based surgery approach in the NHS", says lead investigator Professor Matt Costa.
The team also looked at the cost-effectiveness of both treatments and concluded that IM nail fixation approach is cheaper.
Professor Costa comments: "The economic evaluation done as part of the trial strongly suggests IM nail fixation is the way to go on all accounts when it comes to fractures of the shinbone, so we hope this research can change NICE guidelines and have an impact not only for patients but for the NHS as a whole."
The tibia is the most commonly broken major bone in the leg and injuries usually require surgery, leading to prolonged periods away from work and social activities. Currently, the most common surgical treatment options are IM nail fixation, where a metal rod is inserted into the hollow center of the tibia, and locking plate fixation, where a plate is attached to the surface of the bone with fixed-angle screws.
This research has been published in JAMA, as well as made available as a full report by the NIHR Health Technology Assessment. A full cost analysis report has also been published in Bone and Joint.