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NCT00314600 Clinical Trial

Treatment of Non-Dislocated Midshaft Both-Bone Fractures

Fracture Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00314600
Other study ID # Colaris02
Secondary ID
Status Recruiting
Phase N/A
First received April 12, 2006
Last updated February 23, 2007
Start date January 2006

Study information
Verified date November 2006
Source Colaris, Joost, M.D.
Contact Joost W Colaris, M.D.
Phone 0031-642220265
Email joostcolaris@hotmail.com
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)Netherlands: Medical Ethics Review Committee (METC)
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A to 15 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• above and below elbow cast

Locations
Country Name City State
Netherlands HAGA, Juliana Children's Hospital Den Haag Zuid Holland
Netherlands Erasmus Medical Centre, Sophia Children's Hospital Rotterdam Zuid Holland

Sponsors (1)
Lead Sponsor Collaborator
Colaris, Joost, M.D.

Country where clinical trial is conducted

Netherlands, 

Outcome
Type Measure Description Time frame Safety issue
Primary pronation and supination
Secondary complications, function, esthetics, complaints in daily living, X-rays
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