Treatment of Stable Both-Bone Midshaft Forearm Fractures in Children

NCT ID: NCT00398242

Last Updated: 2006-11-10

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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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.

Detailed Description

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children who arrive at the emergency unit with a stable both-bone midshaft forearm fracture will be asked to join the trial.

If the fracture will be stable during reposition in the operating room, a randomization between 2 kinds of plaster treatment will be done.

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, complains in daily living and complications.

Conditions

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Fracture Forearm Midshaft Child Treatment

Keywords

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fracture forearm midshaft child treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Interventions

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

Role: PRINCIPAL_INVESTIGATOR

Locations

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Erasmus Medical Centre location Sophia Children's hospital

Rotterdam, South Holland, Netherlands

Site Status RECRUITING

HAGA, location 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

Role: CONTACT

Phone: 0031642220265

Email: [email protected]

Facility Contacts

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Joost W Colaris

Role: primary

Joost W Colaris, Drs

Role: primary

References

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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.

Reference Type DERIVED
PMID: 38813962 (View on PubMed)

Other Identifiers

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Colaris03

Identifier Type: -

Identifier Source: org_study_id