Trial Status - Open to Recruitment
Surgery or Cast for Injuries of the EpicoNdyle in Children’s Elbows: A multi-centre prospective randomised superiority trial of operative fixation versus non-operative treatment for medial epicondyle fractures of the humerus.
The management of fractures of the medial epicondyle is one of the greatest controversies in paediatric fracture care. The British Society of Children's Orthopaedic Surgery recently prioritised this as the most important research question in paediatric orthopaedic trauma care. The debate for clinicians is whether to realign and hold the fragments of bone with operative fixation, or whether to allow the fragments to heal in their current position without surgery by resting the elbow in a cast. There is a clear and pressing need to inform patients about the benefits or otherwise of operative fixation versus non-operative treatment, and a need to inform commissioners regarding the costs of the different treatment strategies to the NHS and society. We therefore propose: A multi-centre prospective randomized superiority trial of operative fixation versus non-operative treatment for medial epicondyle fractures of the humerus in children, using a well-established network of children's orthopaedic surgeons engaged in research. The proposed project is a two-phased study. An internal pilot will confirm the expected rate of recruitment in a large-scale multi-centre randomised controlled trial. The main phase will be the proposed randomised controlled trial in a minimum of 35 centres across the UK.
The pilot will take place at 20 centres over a period of 12 months. The aim of this initial phase will be to determine the number of eligible and recruited patients in the trauma centres as well as optimise the electronic data collection procedures. The pilot will seek to recruit 80-120 patients from 20 centres over 12 months. If the trial continues into the main phase, patients from the internal pilot will be included in the final analysis.
The main trial will recruit from a minimum of 35 centres treating children's fractures across the UK. All children presenting at the trial centres with a medial epicondyle fracture of the humerus are potentially eligible to take part in the trial. After consent has been gained, a local research associate will collect baseline demographic data, the Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Score for Children Computer Adaptive Test, DASH Sports/Performing Arts Module, Wong Baker Faces Pain Score, and health-related quality of life using the EuroQoL EQ-5DY. A randomisation sequence, stratified by centre, to account for centre-specific effects, and dislocation-status of the elbow (i.e. dislocated or not-dislocated at presentation to the emergency department) will be produced by the trial statistician. Each patient will be randomly allocated (1:1) to either operative fixation, or non-surgical treatment. Follow-up will be at 4 weeks during routine follow-up, and thereafter made electronically (sent by e-mail or text message) for the Patient Reported Outcomes at 6 weeks, 3 months, 6 months and 12 months (Primary outcome time-point). In exceptional circumstances, data can be collected on paper forms or via telephone interview. Electronic patient follow-up will be administered centrally. The parents of participants will also be asked to complete a resource use questionnaire related to their child's use of healthcare services following treatment for epicondyle fracture at 3, 6 months and 12 months. Patients will then enter a long-term follow-up surveillance phase where a minimal dataset will be requested from them on a yearly basis until 16 years old which for the purposes of this trial has been identified as the point of skeletal maturity. Thereafter the NHS number of participants will be stored to enable future data linkage to sources of routinely collected data (i.e. Hospital Episode Statistics).
The aim of the trial is to determine the clinical and cost-effectiveness of operative fixation versus non-operative treatment for medial epicondyle fractures of the elbow in children.
The primary objective is to quantify and draw inferences on observed differences in function using the Patient Reported Outcomes Measurement Information System (PROMIS) Extremity Limb Score for Children between operative fixation versus non-operative treatment at 1 year post-randomisation for fractures of the medial epicondyle in children
We plan on recruiting a minimum of 334 patients aged between 7 and 15 years inclusive.
Study start date 01/10/2018 and end date 31/10/2022 with further long-term follow-up until skeletal maturity.