NCT03192683

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 20, 2017

Completed
Last Updated

June 20, 2017

Status Verified

June 1, 2017

Enrollment Period

9 months

First QC Date

June 18, 2017

Last Update Submit

June 19, 2017

Conditions

Fractures, BonePediatric ALL

Outcome Measures

Primary Outcomes (1)

  • Patient satisfaction scores

    1 week

Study Arms (2)

Regular sling

ACTIVE COMPARATOR
Device: Regular sling

Cast-sling

EXPERIMENTAL
Device: Providence Pedi Cast-Sling

Interventions

Providence Pedi Cast-SlingDEVICE

Custom made sling with readily available casting materials

Cast-sling
Regular slingDEVICE
Regular sling

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fractures, BonePrecursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Wounds and InjuriesLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Orthopaedic Surgery

Study Record Dates

First Submitted

June 18, 2017

First Posted

June 20, 2017

Study Start

April 1, 2016

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

June 20, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share