K 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

niversity of Warwick (UK)0 个研究点目标入组 320 人开始时间: 2013年1月10日最近更新: 2018年6月18日

适应症

试验速览

•1. Aged 16 years or over, either sex
•2. Any fracture which involves the distal tibial metaphysis - defined as a fracture extending within 2 Muller squares of the ankle joint
•3. In the opinion of the attending surgeon, the patient would benefit from internal fixation of the fracture

•Current exclusion criteria as of 03/02/2014:
•1. In the opinion of the attending surgeon, there is a contraindication to intra-medullary nailing
•2. The fracture is open
•3. There is a contra-indication to anaesthesia
•4. There is evidence that the patient would be unable to adhere to trial procedures or complete postal questionnaires
•Previous exclusion criteria:
•1. In the opinion of the attending surgeon, there is a contraindication to intra-medullary nailing
•2. The fracture is open with a Gustillo grade of more than 1
•3. There is a contra-indication to anaesthesia
•4. There is evidence that the patient would be unable to adhere to trial procedures or complete postal questionnaires

发起方

niversity of Warwick (UK)