Pelvis fracture Injury, Occupational Diseases, Poisoning
Conditions
Interventions
Patients with a pelvic fracture will be referred to one of the hospitals specialising in the treatment of these injuries. Those identified as having sustained an unstable LC1 fracture by their treatin
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. LC1 fracture with complete sacral fracture 2. 16 years and older
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 06/08/2019: 1. Unable to be randomised within 72 hours of having capacity to comprehend the study information following arrival at the major trauma centre 2. Fragility fractures resulting from low-energy trauma (fall from less than standing height) 3. Presenting medical condition which precludes surgical intervention 4. Unable to provide informed consent Previous participant exclusion criteria: 1. No bony anterior pelvic ring injury 2. Unable to be randomised within 2 weeks of injury 3. Unable to mobilise for 6 metres prior to injury 4. Fragility fractures resulting from low-energy trauma (fall from less than standing height) 5. Unfit for anaesthesia 6. Unable to provide informed consent 7. Unable to adhere to Protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The aim of this research study is to perform a feasibility study which will allow the researchers to plan a full definitive trial. A future trial will be deemed to be feasible if the overall recruitment rate is greater than 40% of potential participants per centre per month. The objectives of this feasibility study are; 1. To produce a CONSORT (consolidated standards of reporting trials) diagram, reporting screening, recruitment, randomisation compliance and include allocation proportions by centre 2. To confirm the recruitment rates and percentage of eligible patients who agree to take part 3. To collect outcome data at 2 & 6 weeks, 3, 6, 9 & 12 months post injury to collate the completeness and spread of the data at different time points post injury 4. To identify the outcome measure to be used as the primary outcome on the basis of completeness of data, sensitivity to change over time, the presence of floor or ceiling effects and patient acceptability 5. To develop and refine methods for the collection of resource use data relating to both management pathways 6. To explore patient and staff views of randomisation, treatment and trial processes using qualitative interviews | — |
Secondary
| Measure | Time frame |
|---|---|
| The outcome measures being assessed in this feasibility study for use in a future definitive trial are; 1. Iowa pelvic score – a measure specific to outcomes after pelvic injury 2. Oxford Hip score – a functional score for patients after hip/pelvic injury 3. EQ-5D-5L – a generic quality of life score 4. ICECAP-A – a measure of capability for the general adult population for use in economic evaluation 5. Brief Pain Inventory – a measure of pain severity and its effect on the patient All the above outcomes will be assessed at 2 and 6 weeks, 3, 6, 9 and 12 months to assess the most appropriate timepoints to be chosen for a future definitive trial. In addition the patients functional ability will be measured using the Timed Up and Go assessment carried out by a blinded assessor at 6 week, 3 months and 12 months. | — |
Countries
England, United Kingdom
Outcome results
None listed