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Table 1 ACTIVE and PRESTO study details

From: Embedding qualitative research in randomised controlled trials to improve recruitment: findings from two recruitment optimisation studies of orthopaedic surgical trials

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 13th February 2018 (REC reference 18/YH/0014). Approved by North East – Newcastle and North Tyneside Research Ethics Committee (REC) on 20th 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)