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Study of treatment methods for undisplaced supracondylar humeral (elbow) fractures in children.

The effect of three different types of external immobilisation methods comparing pain during application and functional outcome for children with undisplaced supracondylar humeral fractures.

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12612000480886
Acronym
SUPE study (Study of undisplaced paediatric elbows)
Enrollment
180
Registered
2012-05-02
Start date
2012-08-01
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

The aim of this study is to determine the optimal treatment for uncomplicated elbow fractures (undisplaced supracondylar humeral fractures) in children by comparing three treatment methods. A supracondylar humeral fracture is a fracture or break to the bone immediately above the elbow. Children identified with an undisplaced supracondylar fracture will be randomly allocated to one of three treatment groups which will involve different methods of external immobilisation. Pain during application of these various methods and functional outcome will be measured.

Interventions

To compare the effectiveness of different external immobilisation methods for the management of acute Gartland Type 1 supracondylar humeral fractures, patients will be randomly allocated to 1 of the following 3 treatment groups: Group 1 (control group) will have collar and cuff sling under clothing with elbow flexion at 120 degrees Group 2 (low sling) will have collar and cuff sling under clothing with elbow flexion at 90 degrees Group 3 (backslab) will have a posterior plaster of Paris backsla

To compare the effectiveness of different external immobilisation methods for the management of acute Gartland Type 1 supracondylar humeral fractures, patients will be randomly allocated to 1 of the following 3 treatment groups: Group 1 (control group) will have collar and cuff sling under clothing with elbow flexion at 120 degrees Group 2 (low sling) will have collar and cuff sling under clothing with elbow flexion at 90 degrees Group 3 (backslab) will have a posterior plaster of Paris backslab and collar and cuff sling over clothing with elbow flexion at 50 degrees The patients in all groups will wear the external immobilisation for a total of 3 weeks. Patients in group 1 and 2 will wear the sling day and night. Patients in group 3 will have the posterior backslab insitu for 3 weeks day and night and will wear the sling during the day - the sling may be removed at night when sleeping.

Sponsors

Princess Margaret Hospital for Children
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
3 Years to 8 Years
Healthy volunteers
No

Inclusion criteria

Children presenting to PMH ED aged between 3 and less than 9 years diagnosed with an acute isolated Gartland Type 1 supracondylar humeral fracture confirmed on xray.

Exclusion criteria

Children aged less than 3 years and 9 years or older Supracondylar humeral fractures other than Gartland Type 1 and those which are not isolated fractures Injury sustained more than 3 days ago (ie: not acute) Neurovascular compromise Open fractures Multiple trauma patients Head injury resulting in impaired judgement No parent or legal guardian present who can give informed written consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026