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Self Cast Removal at the Child's Home

A randomised controlled trial to assess the treatment of stable upper limb fractures in children, comparing traditional rigid casts with flexible casts suitable for home removal by the parent

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN55089523
Enrollment
460
Registered
2008-08-13
Start date
2008-05-30
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Upper limb fractures in children Injury, Occupational Diseases, Poisoning Fracture of upper limb, level unspecified

Interventions

Participants will be randomised to one of two basic treatment interventions: 1. Traditional plaster of Paris or fibreglass rigid cast with follow-up in the fracture clinic for removal 2. Home-remova

Sponsors

Oxford Radcliffe Hospitals NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. All children (both males and females) with stable upper limb fracture 2. Aged between 2 and 16 years 3. Presenting within 72 hours of sustaining the injury 4. Attending with a responsible adult

Exclusion criteria

Exclusion criteria: 1. Fracture other than simple torus, greenstick or stable epiphyseal fracture 2. Multi-limb trauma 3. In-patient 4. Suspicion of non-accidental injury 5. Previous surgery or significant injury to affected arm 6. Developmental delay 7. Failure to thrive 8. Pre-existing musculoskeletal disease affecting the upper limb 9. On medications that influence bone metabolism 10.Live outside the hospital catchment area or will find attending for follow-up difficult

Design outcomes

Primary

MeasureTime frame
Clinical equivalence using the difference in Childhood Health Assessment Questionnaire score between pre-injury and one week post cast removal. Equivalence will be defined by a difference of less than 10%.

Secondary

MeasureTime frame
1. Clinical equivalence using the difference in Childhood Health Assessment Questionnaire score between pre-injury and 6 months post cast removal 2. Cost effectiveness of flexible casts over rigid casts 3. User satisfaction of flexible casts using a modified Paediatric Quality of Life Inventory (PedsQL) Healthcare Satisfaction Questionnaire to be completed at 1 week post cast removal

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026