ISRCTN99771224.

Trial name or title	'UK FixDT ‐ A Randomised Controlled Trial for patients with a displaced fracture of the distal tibia, is there a clinical and cost‐effectiveness difference between ‘locking’ plate fixation and intramedullary nail fixation'
Methods	Multicentre randomised clinical trial
Participants	Inclusion criteria: Aged 16 years or over, either sex Any fracture which involves the distal tibial metaphysis – defined as a fracture extending within 2 Muller squares of the ankle joint In the opinion of the attending surgeon, the individual would benefit from internal fixation of the fracture Exclusion criteria: Current exclusion criteria as of 03/02/2014: In the opinion of the attending surgeon, there is a contraindication to intramedullary nailing The fracture is open There is a contraindication to anaesthesia There is evidence that the individual would be unable to adhere to trial procedures or complete postal questionnaires Previous exclusion criteria: In the opinion of the attending surgeon, there is a contraindication to intramedullary nailing The fracture is open with a Gustillo grade of more than 1 There is a contraindication to anaesthesia There is evidence that the individual would be unable to adhere to trial procedures or complete postal questionnaires
Interventions	1. Intramedullary nailing The intramedullary nail is inserted at the proximal end of the tibia and passed down the centre of the bone in order to hold the fracture in the correct (anatomical) position. The reduction technique, the surgical approach, the type and size of the nail, the configuration of the proximal and distal interlocking screws and any supplementary device or technique will be left entirely to the discretion of the surgeon as per standard clinical practice. 2. Locking plate fixation The locking plate is inserted at the distal end of the tibia and passed under the skin on the surface of the bone. Again, the details of the reduction technique, the surgical approach, the type and position of the plate, the number and configuration of fixed‐angle screws and any supplementary device or technique will be left to the discretion of the surgeon. The only stipulation is that fixed‐angle screws must be used in at least some of the distal screw holes – this is standard practice with all distal tibia locking plates.
Outcomes	Primary outcome Disability Rating Index at 6 months after injury Secondary outcomes Early functional status at 3 months and later functional status at 12 months; Olerud and Molander Ankle Functional Score (OMAS) which is a self‐administered questionnaire Radiological outcomes: non‐union, malalignment and shortening Health‐related quality of life in the first year after the injury. EuroQoL (EQ‐5D)‐3‐level Complication rate in the first year after the injury; including malunion, delayed/non‐union, infection, wound complications, vascular and neurological injury, and venous thromboembolism. Any other surgery required in relation to the index fracture, including removal of any metalwork Resource use, costs and comparative cost effectiveness of the two interventions
Starting date	Recruitment start date: 01/03/2013 Recruitment end date: 28/02/2017
Contact information	Prof Matthew Costa, +44 (0)24 7615 1721 (UK) matthew.costa@warwick.ac.uk
Notes	Enrolment target: minimum 320 Ongoing