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. 2021 Mar;2(3):150-163.
doi: 10.1302/2633-1462.23.BJO-2020-0178.

A multicentre, randomized, parallel group, superiority study to compare the clinical effectiveness and cost-effectiveness of external frame versus internal locking plate for complete articular pilon fracture fixation in adults

Lydia Flett  1 , Joy Adamson  1 , Elizabeth Barron  2 , Stephen Brealey  1 , Belen Corbacho  1 , Matthew L Costa  3 , Graham Gedney  4 , Nikolaos Giotakis  5 , Catherine Hewitt  1 , Jessica Hugill-Jones  1 , Deborah Hukins  1 , Ada Keding  1 , Catriona McDaid  1 , Alex Mitchell  1 , Matthew Northgraves  1 , Grace O'Carroll  1 , Adwoa Parker  1 , Arabella Scantlebury  1 , Lynne Stobbart  6 , David Torgerson  1 , Emma Turner  1 , Charlie Welch  1 , Hemant Sharma  2   7
Affiliations

A multicentre, randomized, parallel group, superiority study to compare the clinical effectiveness and cost-effectiveness of external frame versus internal locking plate for complete articular pilon fracture fixation in adults

Lydia Flett et al. Bone Jt Open. 2021 Mar.

Abstract

Aims: A pilon fracture is a severe ankle joint injury caused by high-energy trauma, typically affecting men of working age. Although relatively uncommon (5% to 7% of all tibial fractures), this injury causes among the worst functional and health outcomes of any skeletal injury, with a high risk of serious complications and long-term disability, and with devastating consequences on patients' quality of life and financial prospects. Robust evidence to guide treatment is currently lacking. This study aims to evaluate the clinical and cost-effectiveness of two surgical interventions that are most commonly used to treat pilon fractures.

Methods: A randomized controlled trial (RCT) of 334 adult patients diagnosed with a closed type C pilon fracture will be conducted. Internal locking plate fixation will be compared with external frame fixation. The primary outcome and endpoint will be the Disability Rating Index (a patient self-reported assessment of physical disability) at 12 months. This will also be measured at baseline, three, six, and 24 months after randomization. Secondary outcomes include the Olerud and Molander Ankle Score (OMAS), the five-level EuroQol five-dimenison score (EQ-5D-5L), complications (including bone healing), resource use, work impact, and patient treatment preference. The acceptability of the treatments and study design to patients and health care professionals will be explored through qualitative methods.

Discussion: The two treatments being compared are the most commonly used for this injury, however there is uncertainty over which is most clinically and cost-effective. The Articular Pilon Fracture (ACTIVE) Trial is a sufficiently powered and rigorously designed study to inform clinical decisions for the treatment of adults with this injury. Cite this article: Bone Jt Open 2021;2(3):150-163.

Keywords: Distal tibia; Orthopaedic surgery; Pilon fracture; Randomized controlled trial; Trauma.

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Conflict of interest statement

ICMJE COI statement: H. Sharmais a paid consultant for Orthofix, as was N. Giotakis (until the end of 2018). H. Sharma is also a paid consultant for Biocomposites and has received research grants from Smith & Nephew, BBRaun and Dermol Laboratories. NG has received educational grants from Smith & Nephew, Orthofix and Biocomposites as part of a non-profit organization organizing educational events. HS is also a member of the JLLR editorial board. C. Hewitt and M. L. Costa are members of the UK National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Funding Board. C. McDaid is a member of the NIHR HTA & EME Journal Editorial Board. York Trials Unit receives funding from the British Orthopaedic Association to support grant applications. These associations and grants have not in any way influenced contribution to this study.

Figures

Fig. 1
Fig. 1
Overall schedule of events for the Articular Pilon Fracture (ACTIVE) trial, from eligibility screening, enrolment, treatment and follow-up assessments. aPatient-reported outcome measures collected at baseline include the Disability Rating Index (DRI), Olerud and Molander Ankle Score (OMAS), and five-level EuroQol five-dimension score (EQ-5D-5L). bPatient medical background includes details on whether the patient is diabetic or is immunosuppressed, and details of any polytrauma present at baseline. cAll trial patients will receive standardized written physiotherapy advice. Any further rehabilitation input throughout their treatment pathway will be at the discretion of the clinical team. dPhysiotherapy logbooks completed to record all rehabilitation delivery within the Trust starting from enrolment. eAssessment for pin site infections will be made each time a patient with an external frame attends a hospital visit until the time that the frame is removed, generally before six months, and recorded on a specific Case Report Form (CRF). fRoutine imaging will be used to complete the bone healing assessment at 12 months post-randomization to assess for malunion, nonunion, and secondary arthritis.
Fig. 2
Fig. 2
Pilon fracture treatment flowchart.
Fig. 3
Fig. 3
Pilot study outcome data used in analysis and to inform trial continuation.
See this image and copyright information in PMC

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