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

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ClinicalTrials.gov Identifier: NCT03192683
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : June 20, 2017
Sponsor:
Information provided by (Responsible Party):
Aristides Cruz, Lifespan

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

Condition or disease Intervention/treatment Phase
Fractures, Bone Pediatric ALL Device: Providence Pedi Cast-Sling Device: Regular sling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 71 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Patient and Parent Satisfaction With Sling Use After Pediatric Upper Extremity Fractures: A Randomized Controlled Trial
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fractures

Arm Intervention/treatment
Active Comparator: Regular sling Device: Regular sling
Experimental: Cast-sling Device: Providence Pedi Cast-Sling
Custom made sling with readily available casting materials




Primary Outcome Measures :
  1. Patient satisfaction scores [ Time Frame: 1 week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Aristides Cruz, Assistant Professor, Orthopaedic Surgery, Lifespan
ClinicalTrials.gov Identifier: NCT03192683     History of Changes
Other Study ID Numbers: 400316
First Posted: June 20, 2017    Key Record Dates
Last Update Posted: June 20, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fractures, Bone
Wounds and Injuries