Modified "Providence" Pedi Cast-Sling vs.Cast and Sling | NCT03192683

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

NCT03192683

Sponsor

Lifespan

Status

Completed

Last Update Posted

Jun 20, 2017Actual

Enrollment

71Actual

Phase

Not Applicable

Conditions

Fractures, Bone
Pediatric ALL

Interventions

Providence Pedi Cast-Sling
Regular sling

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2016Actual

Primary Completion Date

Dec 31, 2016Actual

Completion Date

Dec 31, 2016Actual

First Submitted Date

Jun 18, 2017

First Submission Date that Met QC Criteria

Jun 19, 2017

First Posted Date

Jun 20, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 19, 2017

Last Update Posted Date

Jun 20, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

71Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Regular sling	Active Comparator		Device: Regular sling
Cast-sling	Experimental		Device: Providence Pedi Cast-Sling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Providence Pedi Cast-Sling	Device	Custom made sling with readily available casting materials	Cast-sling

Measure	Description	Time Frame
Patient satisfaction scores		1 week

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050723	Fractures, Bone
D054198	Precursor Cell Lymphoblastic Leukemia-Lymphoma

Ancestor Terms

ID	Term
D014947	Wounds and Injuries
D007945	Leukemia, Lymphoid
D007938	Leukemia
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided