Modified "Providence" Pedi Cast-Sling vs.Cast and Sling

NCT ID: NCT03192683

Last Updated: 2017-06-20

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

COMPLETED

Clinical Phase

NA

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-01

Study Completion Date

2016-12-31

Brief Summary

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Examining custom made sling vs. off the shelf sling for immobilization following pediatric upper extremity fractures.

Detailed Description

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Conditions

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Fractures, Bone Pediatric ALL

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Regular sling

Group Type ACTIVE_COMPARATOR

Regular sling

Intervention Type DEVICE

Cast-sling

Group Type EXPERIMENTAL

Providence Pedi Cast-Sling

Intervention Type DEVICE

Custom made sling with readily available casting materials

Interventions

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Providence Pedi Cast-Sling

Custom made sling with readily available casting materials

Intervention Type DEVICE

Regular sling

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients aged 0-18 years old who were evaluated in the pediatric emergency department (ED) by the orthopaedic resident on call
* patients with an upper extremity fracture (wrist, forearm or elbow) that required placement of a long-arm cast.

Exclusion Criteria

* open fractures
* fractures at multiple levels (e.g. wrist AND elbow fracture)
* fractures requiring immediate/urgent surgery
* patients requiring admission for any reason
* bivalved LAC's for any reason
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lifespan

OTHER

Sponsor Role lead

Responsible Party

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Aristides Cruz

Assistant Professor, Orthopaedic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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400316

Identifier Type: -

Identifier Source: org_study_id

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