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Treatment of Non-Dislocated Midshaft Both-Bone Fractures

Above Elbow Cast in Non-Dislocated Both-Bone Midshaft Forearm Fractures in Children: Necessity or Needless Cruelty? A Randomized Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00314600
Enrollment
60
Registered
2006-04-14
Start date
2006-01-31
Completion date
Unknown
Last updated
2007-02-26

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

Conditions

Fracture

Keywords

Fracture, Forearm, Midshaft, Child, Cast

Brief summary

The investigators created a randomized clinical trial to find out what kind of treatment is optimal for non-dislocated both-bone midshaft forearm fractures.

Detailed description

Children who arrive at the emergency unit with a non-dislocated both-bone midshaft forearm fracture will be asked to join the trial. After informed consent we will do a randomization between 6 weeks above elbow cast and 3 weeks above elbow cast in combination with 3 weeks under elbow cast. Outpatient clinic visits till a follow-up of 6 months. During these visits we will investigate: consolidation and dislocation on X-ray, function of both arms, complaints in daily living and complications.

Interventions

DEVICEabove and below elbow cast

Sponsors

Colaris, Joost, M.D.
Lead SponsorINDIV

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
No minimum to 15 Years
Healthy volunteers
Yes

Inclusion criteria

* Both-bone midshaft forearm fracture * Age \< 16 years old

Exclusion criteria

* Dislocation * Fracture older than 1 week * No informed consent * Refracture * Open fracture (Gustillo 2 and 3) * Torus fractures of both ulna and radius

Design outcomes

Primary

MeasureTime frame
pronation and supination

Secondary

MeasureTime frame
complications, function, esthetics, complaints in daily living, X-rays

Countries

Netherlands

Contacts

Primary ContactJoost W Colaris, M.D.
joostcolaris@hotmail.com0031-642220265

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026