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Paediatric distal radius torus fracture treatment comparison in a prospective randomized control trial: mitella versus plaster cast

Paediatric distal radius torus fracture treatment comparison in a prospective randomized control trial: mitella versus plaster cast - Torus fracture therapy comparison

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON43814
Enrollment
108
Registered
2010-10-04
Start date
2010-11-01
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Torus fracture distal radius. Buckle fracture distal radius

Interventions

Randomisation into 2 groups: A. Sling B. Cast + sling

Sponsors

Spoedeisende Hulp
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

Inclusion criteria: Children 5 to 15 years old with: - A torus fracture of the distal radius

Exclusion criteria

Exclusion criteria: Children with: - Greenstick fractures - Torus antebrachii fractures - Children with an additional fracture(s) - Children with a metabolic bone disease - Children with special needs - Language barrier - Children living in another region and therefore are followed-up in another hospital

Design outcomes

Primary

MeasureTime frame
Painscore (VAS 1-100): mean score day 1-4

Secondary

MeasureTime frame
- Painscore (VAS 1-100): mean score first week (day 1-7) and after 2 weeks. - Wrist function with a questionnaire (0-100). The Acitvities Scale for Kids is a validated questionnaire that has been translated [11-12]. The first questionnaire is collected at the ED and concerns the 3 previous days before the EDvisit. Other questionnaires will be collected after 1 and 2 weeks. Every questionnaire concerns the 3 previous days. - Range of motion with goniometer (dorso- and volarflexion of the left and right wrist) - Gripstrength (Power (kg) of the left and right hand) The range of motion and gripstrength will be performed in the ED and after 1 and 2 weeks in the outpatient clinic. Additional variables - Use of pain medication (tablets/day) - Discomfort (itching, too heavy, too tight, too wide, other complaints) - Comfortability of the treatment (5 point scale: very comfortable to very uncomfortable) - Satisfaction of the treatment (5 pointscale: very satisfied to very unsatisfied)

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)