Related Experiment Videos
Protocol for Surgery or Cast of the EpicoNdyle in Children's Elbows (SCIENCE)
Juul Achten1, Duncan Appelbe1, Louise Spoors1
1Oxford Trauma and Emergency Care, Nuffield Department of Orthopaedics, Rheumatology & Musculoskeletal Sciences, University of Oxford, Oxford, UK.
Insights
The SCIENCE trial investigates surgery versus casting for displaced medial epicondyle fractures in children. This study aims to determine the optimal treatment for pediatric elbow fractures, guiding future clinical decisions.
Area of Science:
- Pediatric Orthopedics
- Trauma Surgery
- Clinical Trial Methodology
Background:
- Management of medial epicondyle fractures in children lacks consensus, creating uncertainty regarding surgical intervention.
- This uncertainty led the British Society of Children's Orthopaedic Surgery to prioritize it as a key research question in pediatric trauma.
- The Surgery or Cast of the EpicoNdyle in Children's Elbows (SCIENCE) trial protocol addresses this critical gap.
Purpose of the Study:
- To conduct a randomized controlled, multicenter, prospective superiority trial comparing operative fixation with nonoperative treatment for displaced medial epicondyle fractures in children.
- To provide evidence-based guidance on the optimal management strategy for this common pediatric fracture.
Main Methods:
- Recruitment of children aged 7-15 with displaced medial epicondyle fractures.
- Randomized allocation (1:1) to either surgical fixation or non-surgical treatment, stratified by center and dislocation status.
- Collection of baseline and follow-up data on function (PROMIS upper limb), pain (Wong Baker FACES), and quality of life (EQ-5D-Y) via electronic questionnaires.
Main Results:
- Primary outcome is the Patient-Reported Outcomes Measurement Information System (PROMIS) upper limb score at 12 months post-randomization.
- Secondary outcomes include function, pain, sports/music participation, quality of life, complications, resource use, and school absence, assessed at multiple time points up to age 16.
- Data linkage with routinely collected health data (e.g., Hospital Episode Statistics) will be explored for long-term follow-up.
Conclusions:
- The SCIENCE trial is designed to resolve the controversy surrounding the management of displaced medial epicondyle fractures in children.
- Findings will inform clinical practice guidelines and improve patient outcomes for pediatric elbow fractures.
- This study will contribute significant evidence to the field of pediatric orthopedic trauma.
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).