COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03192683
Recruitment Status : Completed
First Posted : June 20, 2017
Last Update Posted : June 20, 2017
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

Layout table for study information
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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

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
Layout table for additonal information
Responsible Party: Aristides Cruz, Assistant Professor, Orthopaedic Surgery, Lifespan Identifier: NCT03192683    
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Fractures, Bone
Wounds and Injuries