Hip fracture Musculoskeletal Diseases Fracture of neck of femur
Conditions
Interventions
WHiTE 10-LIT is a randomised comparison appended to the World Hip Trauma Evaluation (WHiTE ) Platform. WHiTE is a platform trials framework, designed to efficiently deliver multiple randomised compari
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Platform inclusion criteria: 1. Aged =60 years 2. Diagnosed with a hip fracture that in the opinion of the treating surgeon may benefit from surgical treatment No additional specific inclusion criteria for LIT.
Exclusion criteria
Exclusion criteria: Platform exclusion criteria. 1. Previous participation in the same randomised comparison 2. A second hip fracture (other side) while the patient is still enrolled in the Platform following their first hip fracture Additional specific exclusion criteria for LIT: 1. Body weight estimated to be 100 kg 2. Known subdural haematoma 3. Known allergy to local anaesthetics 4. Severely impaired renal (eGFR <30 ml.min-1) or hepatic (based on clinical history) function 5. Patient has specific contraindications to lidocaine: 5.1. All grades of atrioventricular block; severe myocardial depression; sino-atrial disorders 5.2. Acute porphyria 5. 3. Current congestive cardiac failure 6. Concurrent participation in a clinical trial of a medicinal product or recent participation within 5 half-lives of the last dose of medicinal product 7. Local anaesthetic nerve block administered within the previous 6 hours 8. Known serum albumin <30 g/l
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak post-operative delirium as measured by the Memorial Delirium Assessment Scale (MDAS) at days 1-5 after surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain measured using the standard Functional Pain Scale (FPS)/Pain Assessment in People with Advanced Dementia (PAINAD), for participants with and without mental capacity respectively, before surgery and days 1-5 after surgery. 2. Delirium screening using the 4AT test before surgery and days 1-5 after surgery. 3. Health-related quality of life using the Euroqol-5D-5L pre-injury, at 4 and 12 months post-diagnosis of a hip fracture. 4. Cognitive impairment using the Telephone Interview for Cognitive Status (TICS) at 4 and 12 months post-diagnosis of a hip fracture. 5. Subjective mobility status measured using the UK National Hip Fracture Database Mobility Scale at 4 and 12 months post-diagnosis of a hip fracture 6. Residential status measured using the UK National Hip Fracture Database Residential Status at 4 and 12 months post-diagnosis of a hip fracture 7. Mortality risk using death notification up to 12 months post-diagnosis of a hip fracture 8. Risk and pattern of complications measured using bespoke reporting forms up to 12 months post-diagnosis of a hip fracture. 9. Resource use from an NHS and personal social services perspective calculated using bespoke reporting forms up to 12 months post-diagnosis of a hip fracture. | — |
Countries
England, Northern Ireland, United Kingdom, Wales
Contacts
Public ContactKaty Mironov
Outcome results
None listed