Modified “Providence” Pedi Cast-Sling vs.Cast and Sling

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This study has been completed.


Information provided by (Responsible Party):

Aristides Cruz, Lifespan Identifier:


First received: June 18, 2017

Last updated: June 19, 2017

Last verified: June 2017

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

Fractures, Bone Pediatric ALL Device: Providence Pedi Cast-Sling Device: Regular sling

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Patient and Parent Satisfaction With Sling Use After Pediatric Upper Extremity Fractures: A Randomized Controlled Trial

Primary Outcome Measures:

  • Patient satisfaction scores [ Time Frame: 1 week ]

Enrollment: 71
Actual Study Start Date: April 1, 2016
Study Completion Date: December 31, 2016
Primary Completion Date: December 31, 2016 (Final data collection date for primary outcome measure)
Active Comparator: Regular sling Device: Regular sling
Experimental: Cast-sling Device: Providence Pedi Cast-Sling

Custom made sling with readily available casting materials

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

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No Contacts or Locations Provided

Responsible Party: Aristides Cruz, Assistant Professor, Orthopaedic Surgery, Lifespan Identifier: NCT03192683     History of Changes
Other Study ID Numbers: 400316
Study First Received: June 18, 2017
Last Updated: June 19, 2017
Individual Participant Data  
Plan to Share IPD: No

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

Additional relevant MeSH terms:

Fractures, Bone
Wounds and Injuries processed this record on June 20, 2017