Hip fracture Musculoskeletal Diseases
Conditions
Interventions
WHiTE 13 DECI is a randomised comparison appended to the World Hip Trauma Evaluation (WHiTE) Platform. WHiTE is a platform trial designed to efficiently deliver multiple randomised comparisons of inte
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults aged 60 years or over diagnosed with a hip fracture that in the opinion of the treating surgeon may benefit from surgical treatment
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 25/09/2025: 1. The patient has severely impaired renal function eGFR <30 ml.min-1 2. The patient has severely impaired hepatic function 3. The patient is currently taking any anti-TNF drug 4. The patient has a contra-indication to anti-TNF injection 5. The patient has a known hypersensitivity to any anti-TNF agent or any of the excipients 6. The patient has known active tuberculosis (TB) or a history of TB or is at risk of developing TB e.g. through the use of immunosuppressants 7. The patient has another known active infection (chronic or localised) or known history of recurring infections or conditions which may predispose patients to infection, including the use of concomitant immunosuppressive medications 8. The patient has known lung fibrosis 9. The patient had systemic inflammatory disorder such as rheumatoid arthritis or inflammatory bowel disease 10. The patient has known moderate to severe heart failure (NYHA class III/IV) 11. The patient has HIV, Hepatitis B or C (based on medical history) 12. The patient is at risk of Hepatitis B or HIV infections, including intravenous drug use 13. The patient has been diagnosed with Multiple Sclerosis (MS) or other central or peripheral nervous system demyelinating disorders 14. History of malignancy within 5 years prior to screening or any evidence of persistent malignancy, except basal cell or squamous cell carcinomas of the skin, or cervical carcinoma in situ which has been treated or excised in a curative procedure 15. The patient has had a live vaccination 4 weeks prior to study entry or will require one within 12 weeks after the study intervention 16. The patient takes biologics including anakinra or abatacept or DMARDS. 17. The patient is or has been a participant in a clinical trial of a medicinal product in the last 12 weeks Previous exclusion criteria: 1. The patient has severely impaired renal function eGFR <30 ml.min-1 2. The patient has severely impaired hepatic function 3. The patient is currently taking any anti-TNF drug 4. The patient has a contra-indication to anti-TNF injection 5. The patient has a known hypersensitivity to any anti-TNF agent or any of the excipients 6. The patient has known active tuberculosis (TB) or a history of TB or is at risk of developing TB e.g. through the use of immunosuppressants 7. The patient has another known active infection (chronic or localised) or known history of recurring infections or conditions which may predispose patients to infection, including the use of concomitant immunosuppressive medications 8. The patient has known lung fibrosis 9. The patient had systemic inflammatory disorder such as rheumatoid arthritis or inflammatory bowel disease 10. The patient has known moderate to severe heart failure (NYHA class III/IV) 11. The patient has HIV, Hepatitis B or C (based on medical history) 12. The patient is at risk of Hepatitis B or HIV infections, including intravenous drug use 13. The patient has been diagnosed with Multiple Sclerosis (MS) or other central or peripheral nervous system demyelinating disorders 14. The patient has ever been diagnosed with cancer or current suspected cancer, except basal cell carcinoma (BCC/rodent ulcer) 15. The patient has had a live vaccination 4 weeks prior to study entry or will require one within 12 weeks after the study interventio
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peak postoperative delirium measured using the Memorial Delirium Assessment Scale (MDAS) on days 1-5 after surgery | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cognitive impairment measured using the Telephone Interview for Cognitive Status (TICS) at 4 and 12 months post-diagnosis of a hip fracture 2. Health-related quality of life measured using the Euroqol-5D-5L pre-injury, at 4 and 12 months post-diagnosis of a hip fracture 3. Mortality risk measured using death notification up to 12 months post-diagnosis of a hip fracture 4. Subjective mobility status measured using the UK National Hip Fracture Database Mobility Scale at 4 and 12 months post-diagnosis of a hip fracture 5. Residential status measured using the UK National Hip Fracture Database Residential Status at 4 and 12 months post-diagnosis of a hip fracture 6. Risk and pattern of complications measured using bespoke reporting forms up to 12 months post-diagnosis of a hip fracture | — |
Countries
United Kingdom
Contacts
Public ContactMatthew Costa
Outcome results
None listed