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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN62164933

Enrollment

220

Registered

2024-07-25

Start date

2024-08-01

Completion date

Unknown

Last updated

2026-07-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paediatric supracondylar humeral fractures Injury, Occupational Diseases, Poisoning

Interventions

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

Eligibility

Sex/Gender

All

Age

3 Years to 10 Years

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Current primary outcome measure as of 15/08/2024: 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. _____ Previous primary outcome measure: 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	—

Measure

Time frame

Current primary outcome measure as of 15/08/2024: 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. _____ Previous primary outcome measure: 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

—

Secondary

Measure	Time frame
Current secondary outcome measures as of 15/08/2024: 1. Limb function measured by the PROM PROMIS parent proxy upper extremity short form 8a version 3.0 administered by a blind independent reviewer at 6 months after injury. 2. Global health as measured by the PROM PROMIS parent proxy 7+2 version 3.0 administered by a blind independent reviewer at 6 and 12 months after injury. 3. Parent satisfaction with treatment as measured by a visual analogue scale administered by the treating surgeon team at 3 and 6 months after injury. 4. Complications as measured by a checklist administered by treating surgeons 3 and 6 months after injury 5. Flynn's criteria of elbow form and function administered by treating surgeons 3 and 6 months after injury _____ Previous secondary outcome measures: 1. Carrying angle and range of movement at the elbow measured using Flynn's criteria of elbow function clinically in person by treating surgeons at 3 and 6 months after injury 2. Complications measured in person by treating surgeons at 3 and 6 months after injury. Specific recording of nerve injury (radial, median including anterior interosseous, ulnar), vascular injury or compromise, and infection.	—

Measure

Time frame

Current secondary outcome measures as of 15/08/2024: 1. Limb function measured by the PROM PROMIS parent proxy upper extremity short form 8a version 3.0 administered by a blind independent reviewer at 6 months after injury. 2. Global health as measured by the PROM PROMIS parent proxy 7+2 version 3.0 administered by a blind independent reviewer at 6 and 12 months after injury. 3. Parent satisfaction with treatment as measured by a visual analogue scale administered by the treating surgeon team at 3 and 6 months after injury. 4. Complications as measured by a checklist administered by treating surgeons 3 and 6 months after injury 5. Flynn's criteria of elbow form and function administered by treating surgeons 3 and 6 months after injury _____ Previous secondary outcome measures: 1. Carrying angle and range of movement at the elbow measured using Flynn's criteria of elbow function clinically in person by treating surgeons at 3 and 6 months after injury 2. Complications measured in person by treating surgeons at 3 and 6 months after injury. Specific recording of nerve injury (radial, median including anterior interosseous, ulnar), vascular injury or compromise, and infection.

—

Countries

Ethiopia

Contacts

Public ContactWilliam James Harrison

jharrison@ao-alliance.org+44 (0)356 0000

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Jul 23, 2026