Back to resultsModified "Providence" Pedi Cast-Sling vs.Cast and Sling
Primary Purpose
Fractures, Bone, Pediatric ALL
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Providence Pedi Cast-Sling
Regular sling
Sponsored by
About this trial
This is an interventional treatment trial for Fractures, Bone
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Regular sling
Cast-sling
Arm Description
Outcomes
Primary Outcome Measures
Patient satisfaction scores
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03192683
Brief Title
Modified "Providence" Pedi Cast-Sling vs.Cast and Sling
Official Title
Patient and Parent Satisfaction With Sling Use After Pediatric Upper Extremity Fractures: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
April 1, 2016 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lifespan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Examining custom made sling vs. off the shelf sling for immobilization following pediatric upper extremity fractures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fractures, Bone, Pediatric ALL
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
71 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Regular sling
Arm Type
Active Comparator
Arm Title
Cast-sling
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Providence Pedi Cast-Sling
Intervention Description
Custom made sling with readily available casting materials
Intervention Type
Device
Intervention Name(s)
Regular sling
Primary Outcome Measure Information:
Title
Patient satisfaction scores
Time Frame
1 week
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Modified "Providence" Pedi Cast-Sling vs.Cast and Sling
We'll reach out to this number within 24 hrs