NCT00314600

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 12, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 14, 2006

Completed
Last Updated

February 26, 2007

Status Verified

November 1, 2006

First QC Date

April 12, 2006

Last Update Submit

February 23, 2007

Conditions

Fracture

Keywords

FractureForearmMidshaftChildCast

Outcome Measures

Primary Outcomes (1)

  • pronation and supination

Secondary Outcomes (1)

  • complications, function, esthetics, complaints in daily living, X-rays

Interventions

above and below elbow castDEVICE

Eligibility Criteria

AgeUp to 15 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Erasmus Medical Centre, Sophia Children's Hospital

Rotterdam, South Holland, 3015GJ, Netherlands

NOT YET RECRUITING

HAGA, Juliana Children's Hospital

The Hague, South Holland, 2566ER, Netherlands

RECRUITING

Related Publications (1)

  • Colaris JW, Reijman M, Allema JH, Biter LU, Bloem RM, van de Ven CP, de Vries MR, Kerver AJ, Verhaar JA. Early conversion to below-elbow cast for non-reduced diaphyseal both-bone forearm fractures in children is safe: preliminary results of a multicentre randomised controlled trial. Arch Orthop Trauma Surg. 2013 Oct;133(10):1407-14. doi: 10.1007/s00402-013-1812-8. Epub 2013 Jul 17.

    PMID: 23860674DERIVED

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Joost W Colaris, M.D.

    HAGA/Erasmus Medical Centre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joost W Colaris, M.D.

CONTACT

0031-642220265joostcolaris@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDIV

Study Record Dates

First Submitted

April 12, 2006

First Posted

April 14, 2006

Study Start

January 1, 2006

Last Updated

February 26, 2007

Record last verified: 2006-11

Locations

NL(2)