Modified "Providence" Pedi Cast-Sling vs.Cast and Sling
Sponsor
Lifespan (Other)
Overall Status
Completed
CT.gov ID
NCT03192683
Collaborator
(none)
71
2
9
Study Details
Study Description
Brief Summary
Examining custom made sling vs. off the shelf sling for immobilization following pediatric upper extremity fractures.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
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
:
Apr 1, 2016
Actual Primary Completion Date
:
Dec 31, 2016
Actual Study Completion Date
:
Dec 31, 2016
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Patient satisfaction scores [1 week]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
to 18 Years
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Lifespan
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Aristides Cruz,
Assistant Professor, Orthopaedic Surgery,
Lifespan
ClinicalTrials.gov Identifier:
NCT03192683
Other Study ID Numbers:
- 400316
First Posted:
Jun 20, 2017
Last Update Posted:
Jun 20, 2017
Last Verified:
Jun 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
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: