NCT00398242

Brief Summary

We create a randomized clinical trial between the treatment with above elbow armcast alone and the treatment of above elbow in combination with a short arm cast for stable midshaft both-bone 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
10 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 10, 2006

Completed
Last Updated

November 10, 2006

Status Verified

November 1, 2006

First QC Date

November 8, 2006

Last Update Submit

November 8, 2006

Conditions

FractureForearmMidshaftChildTreatment

Keywords

fractureforearmmidshaftchildtreatment

Outcome Measures

Primary Outcomes (1)

  • pronation and supination

Secondary Outcomes (1)

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

Interventions

above or below elbow cast for the last 3 weeks of treatmentDEVICE

Eligibility Criteria

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

You may qualify if:

  • both-bone forearm fracture
  • age \< 16 years
  • dislocation
  • stable

You may not qualify if:

  • fracture older than 1 week
  • no informed consent
  • refracture
  • open fracture (Gustillo 2 and 3)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Erasmus Medical Centre location Sophia Children's hospital

Rotterdam, South Holland, Netherlands

RECRUITING

HAGA, location Juliana Children's Hospital

The Hague, South Holland, Netherlands

RECRUITING

Related Publications (1)

  • Musters L, Roth KC, Diederix LW, Edomskis PP, Benner JL, Reijman M, Eygendaal D, Colaris JW. Does Early Conversion to Below-elbow Casting for Pediatric Diaphyseal Both-bone Forearm Fractures Adversely Affect Patient-reported Outcomes and ROM? Clin Orthop Relat Res. 2024 Oct 1;482(10):1873-1881. doi: 10.1097/CORR.0000000000003100. Epub 2024 May 7.

    PMID: 38813962DERIVED

MeSH Terms

Conditions

Fractures, Bone

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Joost W Colaris, Drs

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Joost W Colaris

CONTACT

0031642220265joostcolaris@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDIV

Study Record Dates

First Submitted

November 8, 2006

First Posted

November 10, 2006

Study Start

January 1, 2006

Last Updated

November 10, 2006

Record last verified: 2006-11

Locations

NL(2)