A radomised controlled trial of two methods of immobilising supracondylar fractures of the humerus.

Is immobilisation with collar and cuff or backslab and sling associated with less pain and better parent satisfaction in children with minimally displaced supracondylar fractures of the humerus?

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12607000047493

Enrollment

Registered

2007-01-12

Start date

2003-09-01

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

This is a prospective, randomised study to ascertain if plaster slab immobilisation of the arm is equally acceptable to parents and patients as collar and cuff immobilisation for undisplaced supracondylar fractures (breaks) of the upper arm near the elbow. All children aged 18 months to less than 11 years, presenting to the Emergency Department who sustain this type of break of the upper arm, will be enrolled into the study and randomised to receive one of two methods of immobilisation. Parents will be asked to keep a daily diary of analgesia use, child complaints or perceived problems with the mode of immobilisation. Followup will be 2 weeks post ED presentation, at which time the slab/collar will be removed and the supracondylar fracture xrayed and reassessed. At this time a parent/patient satisfaction questionnaire will be completed. If significant tenderness and discomfort remain the arm will be immobilised again and reviewed again in 2 weeks in ED.

Interventions

Intervention: Immobilisation in a fiberglass back slab and sling Immobilisation is for 2 weeks then reviewed. If necessary immobilisation for a further 2 weeks will be implemented. Patients are reviewed 2 weeks after mobilisation by phone.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Months to 11 Years

Healthy volunteers

Inclusion criteria

Presenting to the Emergency Department of the Royal Children's hospital Melbourne And Undisplaced and minimally displaced supracondylar fractures of the distal upper arm.

Exclusion criteria

Other associated fractures of the same arm or more than 10 degrees of angulation of the distal segment (lower part) of the humeral fracture. Children with these conditions will be referred to the Orthopaedic Department as per normal practice.

Outcome results