Medial epicondyle fractures of the humerus Injury, Occupational Diseases, Poisoning
Conditions
Interventions
Current interventions as of 19/07/2019:
Randomisation:
The patient will be randomised after consent. All hospital treatment areas have access to the internet so will access the randomisation service i
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
7 Years to 15 Years
Inclusion criteria
Inclusion criteria: 1. Radiographic evidence of a displaced medial epicondyle fracture of the humerus, with fracture displacement determined by the surgeon as per their usual clinical practice 2. Aged between 7 and 15 years old inclusive
Exclusion criteria
Exclusion criteria: 1. The injury is more than two weeks old 2. There is incarceration of the medial epicondyle fragment within the elbow joint 3. The injury is part of a complex elbow fracture (i.e. fracture extending into the joint) 4. There are other fractured bones elsewhere in the body, in addition to the elbow injury 5. The elbow, if dislocated, is unable to be realigned into a satisfactory position in the emergency department. 6. There is evidence that the patient and/or parent/guardian would be unable to adhere to trial procedures or complete follow-up, such as insufficient English language comprehension, developmental delay or a developmental abnormality or no access by parents to the internet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Upper limb function measured using the Patient Reported Outcomes Measurement Information System (PROMIS) Upper Extremity Score for Children at 1 year post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Upper limb function measured using the PROMIS Upper Extremity Score at Week 6, Months 3 and 6 2. Sports and performing arts participation measured using the DASH S/PA Module (a validated assessment of higher-level upper limb function) at Week 6, Months 3, 6 and 12 3. Pain measured using the Wong-Baker FACES Pain Rating Scale at Week 6, Months 3, 6 and 12 4. Quality of life measured using EQ5DY at Week 6, Months 3, 6 and 12 5. Complication rate, including the need for further operative fixation, at Weeks 4 and 6, Months 3, 6 and 12 6. Cost-effectiveness of the two treatments to the NHS and broader society at Months 3, 6 and 12 7. Barriers and facilitators to recruitment to this study and other paediatric surgical trials (pilot phase only) assessed using qualitative interviews with children, parent/guardians and trial staff | — |
Countries
Australia, England, New Zealand, Northern Ireland, Scotland, United Kingdom, Wales
Outcome results
None listed