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

Effectiveness of straight arm traction versus operative treatment for displaced pediatric supracondylar humerus fractures: a randomized controlled trial

Registry ID

ISRCTN62164933

Source registry

ISRCTN

Status

Recruiting

Study type

INTERVENTIONAL

Sponsor

AO Alliance Foundation

Enrollment

220

Start date

2024-08-01

Completion date

2027-09-30

Last update

2026-08-17

Conditions

• Injury, Occupational Diseases, Poisoning

Summary

Paediatric supracondylar humeral fractures

Detailed description

Randomisation (computer generated) between two accepted treatment options to test for non-inferiority in the low- and middle-income country context. The two recognised treatments are: 1. Non-operative using lateral straight arm traction 2. Operative using closed reduction and percutaneous pinning

Interventions

• OTHER: Randomisation (computer generated) between two accepted treatment options to test for non-inferiority in the low- and middle-income country context. The two recognised treatments are: 1. Non-operative using lateral straight arm traction 2. Operative using closed reduction and percutaneous pinning

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

Locations

• , , Ethiopia

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