Treatment of Non-Dislocated Midshaft Both-Bone Fractures

NCT ID: NCT00314600

Last Updated: 2007-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Brief Summary

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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

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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.

Conditions

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Fracture

Keywords

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Fracture Forearm Midshaft Child Cast

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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above and below elbow cast

Intervention Type DEVICE

Eligibility Criteria

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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
Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Colaris, Joost, M.D.

INDIV

Sponsor Role lead

Principal Investigators

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Joost W Colaris, M.D.

Role: PRINCIPAL_INVESTIGATOR

HAGA/Erasmus Medical Centre

Locations

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Erasmus Medical Centre, Sophia Children's Hospital

Rotterdam, South Holland, Netherlands

Site Status NOT_YET_RECRUITING

HAGA, Juliana Children's Hospital

The Hague, South Holland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Joost W Colaris, M.D.

Role: CONTACT

Phone: 0031-642220265

Email: [email protected]

Facility Contacts

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Joost W Colaris, M.D.

Role: primary

Joost W Colaris, M.D.

Role: primary

References

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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.

Reference Type DERIVED
PMID: 23860674 (View on PubMed)

Other Identifiers

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Colaris02

Identifier Type: -

Identifier Source: org_study_id