Treatment of Distal Radius Buckle Fractures

NCT ID: NCT01762605

Last Updated: 2022-03-07

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

TERMINATED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-11-30

Brief Summary

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This study determines if patients with buckle fractures of the distal radius and/or ulna treated with supportive care only demonstrate non-inferior outcomes in regard to pain control during healing, functional outcome at the wrist joint, and parental satisfaction, when compared with patients treated with the standard treatment regimen of 3-4 weeks in a short arm cast.

Detailed Description

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Conditions

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Fracture Treatment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Supportive Care

No casting or splinting, supportive care only by parents

Group Type EXPERIMENTAL

Supportive Care

Intervention Type OTHER

Cast

Casting for 4 weeks

Group Type ACTIVE_COMPARATOR

Cast

Intervention Type PROCEDURE

Interventions

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Supportive Care

Intervention Type OTHER

Cast

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

Children age 1-17 with buckle fractures of the distal radius and/or ulna. -

Exclusion Criteria

* Patients are excluded if there is any other injury to the upper limb or serious bodily trauma that might complicate pain scores. Children with suspected or proven metabolic bone disease, or pathologic fractures are excluded due to resultant abnormal bone healing.
Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Wake Forest University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Frino, MD

Role: PRINCIPAL_INVESTIGATOR

Atrium Health Wake Forest Baptist

Other Identifiers

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IRB00012567

Identifier Type: -

Identifier Source: org_study_id

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