Trial Status: In Closure
Our aim is to conduct a randomised trial in order to determine the clinical and cost effectiveness of intra-medullary nails versus external fixation for segmental tibial fractures.
Every year, many people break their legs. In 12%, the tibia (shin bone) fractures into several pieces that sometimes poke out through the skin requiring a difficult operation. There are two main ways to carry out the operation, either putting a metal rod in the bone or a metal frame outside the bone to help it heal. We do not know which operation is better as previous research looking at these treatments has not been done well and has not provided any definite answers.
We are planning a study across the NHS to compare treatment with a metal rod to a frame to see which is better. Before we do a large study like this we need to consider how best to run it and if it will work in practice. We need to know if patients and surgeons would be willing to take part, how they feel about the two different operations and how we should measure “success” after the operation. This is called a feasibility study and will tell us if a larger study is possible and how it should be run to give us an answer.
The STIFF-F Pilot Feasibility Study 2021 publication can be found here