Trial of Acute Femoral Fracture Fixation (TrAFFix): study protocol for a randomised controlled feasibility trial

Table 1 Schedule of enrolment, interventions and assessments

	Study period
	Enrolment	Allocation	Post allocation
Time point	0	0	6 weeks	4 months
Enrolment
Eligibility:
Fracture classification [31]	X
Cognitive impairment	X	X
Age (≥50 years)	X
Informed consent/agreement	X
Intervention
Intervention A		X
Intervention B		X
Additional fixation		X
Anaesthesia		X
Grade of surgeon		X
Prescribed medications		X
Rehab assessment		X
Assessments
Baseline characteristics:
Contact details
Date of birth		X
Sex		X
Current medications		X
Comorbidities		X
Current/previous occupation		X
Educational attainment		X
Grip strength		X	X	X
Self-efficacy report		X
Rockwood Frailty Scale score		X
MOS social support		X
Government benefits		X
Residential status		X
Discharge destination		X
Mobility		X
Outcomes
EQ-5D-5 L		Pre + post injury	X	X
DEMQoL^a		Pre + post injury	X	X
DRI^b		Pre + post injury	X	X
Radiographs		X	X
Complications		X	X	X
Health economics				X
Qualitative interviews^c		X	X	X

^aPatients with chronic cognitive impairment, ^bPatients without chronic cognitive impairment, ^cSelection of patients and staff
DEMQoL Dementia Quality of Life, DRI Dementia Rating Index, EQ-5D-5 L EuroQol 5 Dimensions (5 L) Score MOS Medical Outcomes Survey

ISSN: 1745-6215