Acetabular Fractures in older patients Intervention Trial (AceFIT): a feasibility triple-arm randomized controlled study.
Andrew CarrothersRonan O'LearyPeter HullDaud ChouJoseph AlsousouJoseph QueallySimon J BondMatthew L CostaPublished in: The bone & joint journal (2024)
This study has shown a full-scale RCT to be feasible, but will need international recruitment. The Acetabular Fractures in older patients Intervention Trial (AceFIT) has informed the design of a multinational RCT sample size of 1,474 or 1,974 patients for a minimal clinically important difference of 0.06 on EQ-5D, with a power of 0.8 or 0.9, and loss to follow-up of 20%. This observed patient cohort comprises a medically complex group requiring multidisciplinary care; surgeon, anaesthetist, and ortho-geriatrician input is needed to optimize recovery and rehabilitation.
Keyphrases
- phase iii
- randomized controlled trial
- phase ii
- end stage renal disease
- study protocol
- clinical trial
- open label
- healthcare
- ejection fraction
- newly diagnosed
- chronic kidney disease
- total hip arthroplasty
- total hip
- peritoneal dialysis
- quality improvement
- double blind
- palliative care
- prognostic factors
- case report
- placebo controlled
- total knee arthroplasty
- patient reported outcomes