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. 2024 Jan 25;5(1):69-77.
doi: 10.1302/2633-1462.51.BJO-2023-0127.R1.

Protocol for Surgery or Cast of the EpicoNdyle in Children's Elbows (SCIENCE)

Juul Achten  1 , Duncan Appelbe  1 , Louise Spoors  1 , Nicholas Peckham  2 , Rebecca Kandiyali  3 , James Mason  3 , David Ferguson  4 , James Wright  5 , Nicola Wilson  6 , Jennifer Preston  7   8 , Amy Moscrop  9 , Matthew Costa  1 , Daniel C Perry  1   7   8
Affiliations

Protocol for Surgery or Cast of the EpicoNdyle in Children's Elbows (SCIENCE)

Juul Achten et al. Bone Jt Open. .

Abstract

Aims: The management of fractures of the medial epicondyle is one of the greatest controversies in paediatric fracture care, with uncertainty concerning the need for surgery. The British Society of Children's Orthopaedic Surgery prioritized this as their most important research question in paediatric trauma. This is the protocol for a randomized controlled, multicentre, prospective superiority trial of operative fixation versus nonoperative treatment for displaced medial epicondyle fractures: the Surgery or Cast of the EpicoNdyle in Children's Elbows (SCIENCE) trial.

Methods: Children aged seven to 15 years old inclusive, who have sustained a displaced fracture of the medial epicondyle, are eligible to take part. Baseline function using the Patient-Reported Outcomes Measurement Information System (PROMIS) upper limb score, pain measured using the Wong Baker FACES pain scale, and quality of life (QoL) assessed with the EuroQol five-dimension questionnaire for younger patients (EQ-5D-Y) will be collected. Each patient will be randomly allocated (1:1, stratified using a minimization algorithm by centre and initial elbow dislocation status (i.e. dislocated or not-dislocated at presentation to the emergency department)) to either a regimen of the operative fixation or non-surgical treatment.

Outcomes: At six weeks, and three, six, and 12 months, data on function, pain, sports/music participation, QoL, immobilization, and analgesia will be collected. These will also be repeated annually until the child reaches the age of 16 years. Four weeks after injury, the main outcomes plus data on complications, resource use, and school absence will be collected. The primary outcome is the PROMIS upper limb score at 12 months post-randomization. All data will be obtained through electronic questionnaires completed by the participants and/or parents/guardians. The NHS number of participants will be stored to enable future data linkage to sources of routinely collected data (i.e. Hospital Episode Statistics).

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Conflict of interest statement

J. Achten and M. L. Costa's employer (the University of Oxford, UK) receives research grant funding from the National Institute for Health and Care Research (NIHR) and Wellcome for research into musculoskeletal trauma, unrelated to this study. D. Appelbe reports institutional funding for this study from NIHR/Health Technology Assessment (HTA). R. Kandiyali, D. C. Perry, and J. Mason report funding for this study from the NIHR/HTA. D. C. Perry is also a NIHR Research Professor. N. C. Wilson reports institutional payments for this study from the Starship Foundation, and is Chair of the Starship Paediatric Orthopaedic Clinical Excellence Group. J. Wright reports grants or contracts from Canadian Institutes of Health Research, National Institutes of Health, and NIHR, unrelated to this study, and is an unpaid chair of PERK 2.

References

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