Table IV.

Details of trial registration for ACTIVE as per the recommended World Health Organization Trial Registration Data Set

Trial registration	ISRCTN98152560
Date of registration	06/03/2018
Funder information	The National Institute for Health Research Health Technology Assessment programme (reference number: 15/130/84)
Sponsor	Hull University Teaching Hospitals NHS Trust
Scientific title	External frame versus internal locking plate for articular pilon fracture fixation: a multicentre randomized controlled trial
Countries of recruitment	England, Wales, Scotland, Northern Ireland and also exploring recruitment internationally
Health condition(s) or problem(s) studied	Closed pilon fracture of the tibia, classified AO 43 C
Intervention(s)	Arm 1: Internal plate fixation (‘locking’ plate)	Arm 2: External frame fixation (limited open reduction and articular fixation)
Key inclusion and exclusion criteria	Inclusion criteria: Patients aged ≥ 16 years; With closed pilon fractures, classified AO 43 C which can be bi-lateral and patients with polytrauma; Where the treating surgeon believes the patient will benefit from surgical fixation.
	Exclusion criteria: Prior failed fixation; Pathological fracture; Patient is/would be unable to understand instructions for treatment More than 21 days since injury Pre-existing (pre-injury) skin condition which precludes open surgery
Study type	Interventional
	Allocation: randomized controlled trial with 1:1 allocation
	Primary purpose: superiority study comparing clinical and cost-effectiveness of interventions
Date of first enrolment	March 2018
Target sample size	334
Recruitment status	Recruiting
Primary outcome	DRI at 12 months
Key secondary outcomes	OMAS; DRI; health-related quality of life (EQ-5D-5L); complications (including nonunion); resource use (e.g. impact on the NHS and productivity).

DRI, Disability Rating Index; OMAS, Olerud-Molander Ankle Score.