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

Pediatric ALL Clinical Trial

Official title:

Patient and Parent Satisfaction With Sling Use After Pediatric Upper Extremity Fractures: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03192683
• Other study ID #: 400316
• Status: Completed
• Phase: N/A
• First received: June 18, 2017
• Last updated: June 19, 2017
• Start date: April 1, 2016
• Est. completion date: December 31, 2016

Study information

• Verified date: June 2017
• Source: Lifespan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Fractures, Bone
• Pediatric ALL

Intervention

Device:
• Providence Pedi Cast-Sling
Custom made sling with readily available casting materials
• Regular sling

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lifespan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient satisfaction scores		1 week