Trial comparing a non-operative and standard operative treatment for children's fractures above the elbow in the low- and middle-income context

Not Applicable

• Conditions: Paediatric supracondylar humeral fractures; Injury, Occupational Diseases, Poisoning

• Registration Number: ISRCTN62164933
• Lead Sponsor: AO Alliance Foundation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-25
• Last Update Posted: 26 August 2024
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1. Patient attending hospital with fresh supracondylar humeral fracture
2. Age range 3 to 10 years

Exclusion Criteria

1. Open fracture
2. Patient with critical ischaemia
3. Delayed presentation after 72 hours of injury

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 15/08/2024: <br><br>Limb function as measured by the PROM PROMIS Parent Proxy Upper Extremity Short Form 8a version 3.0 administered by blind independent reviewer at 12 months after injury.<br><br>_____<br><br>Previous primary outcome measure:<br><br>Quality of life measured using PROMIS 7+2 pediatric PROM administered as a telephone questionnaire using blind independent technicians to patient guardians at 3, 6 and 12 months after injury