STIFF- F Segmental Tibial Fracture Fixation - a Feasibility Study
Research type
Research Study
Full title
Segmental Tibial fractures, reamed Intramedullary nailing versus circular Frame external Fixation - a Feasibility study
IRAS ID
246299
Contact name
Caroline Hing
Contact email
Sponsor organisation
St George’s University Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN11229660
Duration of Study in the UK
1 years, 4 months, 30 days
Research summary
Every year, many people break their legs. In 12%, the shin bone (tibia) breaks into several pieces, sometimes poking out through the skin. A difficult operation is needed to repair the bone. There are two main ways to carry out the operation to help the bone heal, either putting a metal rod in the bone or a metal frame around the leg. 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 asked patients who had treatment for a broken shin how they felt about their injury and recovery. The group described how their recovery was long and difficult. They worried about complications such as infection and social isolation due to a lack of mobility. They described how the injury made them feel dependent on their families. Patients with a metal rod worried that they had a metal implant left permanently in their body, whilst those treated with a metal frame complained of lack of sleep and the physical and psychological perceived disability caused by the frame.
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 if it will work in practice and how best to run it. We need to know if patients and surgeons would be willing to take part, how they feel about the two different operations, what treatment after surgery looks like 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 in order to give us an answer.REC name
South Central - Berkshire Research Ethics Committee
REC reference
19/SC/0073
Date of REC Opinion
20 Feb 2019
REC opinion
Favourable Opinion