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


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This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Aristides Cruz, Lifespan

ClinicalTrials.gov Identifier:

NCT03192683

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

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, see Learn About Clinical Studies.

No Contacts or Locations Provided

Responsible Party: Aristides Cruz, Assistant Professor, Orthopaedic Surgery, Lifespan
ClinicalTrials.gov 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

ClinicalTrials.gov processed this record on June 20, 2017