Distal Tibia Fractures / Injuries & Accidents Injury, Occupational Diseases, Poisoning Fracture of shaft of tibia
Conditions
Interventions
Comparing two techniques for the operative fixation of fractures of the distal tibia.
Intramedullary nailing
The intramedullary nail is inserted at the proximal end of the tibia and passed down the
Sponsors
University of Warwick (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To quantify and draw inferences on observed differences in the Disability Rating Index between the trial treatment groups at 6 months after injury | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To quantify and draw inferences on observed differences early functional status at 3 months and later functional status at 12 months 2.To quantify and draw inferences on observed differences in the radiological outcomes: non-union, mal-alignment and shortening 3. To identify any differences in health-related quality of life between the trial treatment groups in the first year after the injury. EQ-5D; The EQ-5D is a validated, generic health-related quality of life measure consisting of 5 dimensions each with a 3-level answer possibility. Each combination of answers can be converted into a health utility score. It has good test-retest reliability, is simple for patients to use, and gives a single preference-based index value for health status that can be used for broader cost-effectiveness comparative purposes. 4. To determine the complication rate of intramedullary nail fixation versus 'locking'-plate fixation in the first year after the injury. all complications will be recorded, including malunion, delayed/non-union, infection, wound complications, vascular and neurological injury and venous thrombo-embolism. A record will also be kept of any other surgery required in relation to the index fracture, including removal of any metalwork. 5. To investigate, using appropriate statistical and economic analytical methods, the resource use, costs and comparative cost effectiveness of intramedullary nail fixation versus 'locking'-plate fixation Olerud and Molander (OMAS) is a self-administered patient questionnaire. It is a good outcome tool for assessing symptoms after an ankle fracture. The score is based on nine different items: pain, stiffness, swelling, stair climbing, running, jumping, squatting, supports and work/activities of daily living. The scoring system correlates well with parameters considered to summarise the results after this type of injury and is therefore recommended for use in scientific investigations. | — |
Countries
United Kingdom
Outcome results
None listed