Table 1 ACTIVE and PRESTO study details

Objectives

To investigate the clinical and cost-effectiveness of internal plate fixation versus external fine wire fixation for the management of type C pilon fractures of the distal tibia.

To establish whether it is feasible to deliver a trial comparing surgical fixation to initial non-surgical management for patients with a stable thoracolumbar fracture without spinal cord injury.

Design

Parallel randomised controlled trial. A 12-month internal pilot with associated qualitative study to assess recruitment and provide guidance on optimising trial processes.

A feasibility study consisting of three elements: a randomised external feasibility study, a national survey of surgeons and a qualitative study.

Trial interventions

Arm 1: Internal fixation: ‘Locking’ plate fixation with screws.

Arm 2: External frame fixation: limited open reduction and articular fixation using screws and fine wire fixator.

Arm 1: Surgical fixation. Either open spinal surgery or minimally invasive surgery as per current UK surgical treatment.

Arm 2: Non-surgical management. Mobilisation in a brace or mobilisation without a brace.

Primary outcome

Disability Rating Index at 12 months post-randomisation.

Recruitment rate, defined as the proportion of eligible participants who are randomised.

Trial status and registration

Ongoing (ISRCTN98152560)

Completed (ISRCTN12094890)

Ethical approval

Approved by Yorkshire and The Humber – Bradford Leeds REC on 13^th February 2018 (REC reference 18/YH/0014).

Approved by North East – Newcastle and North Tyneside Research Ethics Committee (REC) on 20^th March 2018 (REC reference 18/NE/0008).

Funder

NIHR Health Technology Assessment Programme (HTA 15/130/84)

NIHR Health Technology Assessment Programme (HTA 15/154/07)