Extrait

Background and study aims The tibia (shinbone or shankbone) is the most commonly broken major bone in the leg. Injuries usually require hospital admission, frequently require surgery and result in prolonged periods (months) away from work and social activities. The treatment of displaced, extra-articular fractures of the distal tibia (lower third) remains controversial. These injuries are difficult to manage due to the limited soft tissue cover, poor vascularity of the area and proximity of the fracture to the ankle joint. Infections, non-union and malunion are well-recognised complications. The aim of this study is to find out whether there is a clinical and cost-effectiveness difference between two techniques for the operative fixation of fractures of the distal tibia: locking-plate fixation and intramedullary nail fixation. Who can participate? All patients aged 16 years or over presenting at the trial centres with an isolated, acute fracture of the distal tibia are potentially eligible to take part in the trial. What does the study involve? Participants will be randomly allocated to either intramedullary nailing or locking-plate fixation. Both of these operations are widely used within the NHS and all of the surgeons in the chosen centres will be familiar with both techniques. A research associate will perform a clinical assessment and make a record of any early complications at 6 weeks after the operation and an x-ray will be taken. A further clinical assessment and x-ray will also be taken at 12 months after the operation to detect late complications. Participants will complete questionnaires at 3 months, 6 months and 12 months after the operation. What are the possible benefits and risks of participating? The patient may benefit from internal fixation of the fracture. The risks associated with this study are predominantly the risks associated with the surgery: infection, bleeding and damage to the adjacent structures such as nerves, blood vessels and tendons. Participants in both groups will undergo surgery and will potentially be at risk from any/all of these complications. There is no data to suggest that the risk is greater in one group or another. We believe that the overall risk profile is similar for the two interventions but assessment of the number of complications in each group is a secondary objective of this trial. Where is the study run from? The University of Warwick in collaboration with University Hospitals Coventry and Warwickshire NHS Trust. When is the study starting and how long is it expected to run for? March 2013 to February 2017. Who is funding the study? NIHR Health Technology Assessment Programme - HTA (UK). Who is the main contact? Professor Matthew Costa [email protected]

Critère d'inclusion

• Distal Tibia Fractures / Injuries & Accidents

Liens

• isrctn
• ictrp