NCT01912365

Brief Summary

Elbow fractures are very common in young children. Type I supracondylar fractures are stable fractures to the elbow that are treated conservatively across the world and typically heal very well without complications. There are several treatment options, including an above elbow cast or long arm splint. This study aims to determine if one treatment is no worse than the other in order to standardize the treatment of these fractures at our institution. The investigators hope to save families from extra hospital visits and reduce the amount of x-rays required for treatment of these fractures.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

July 26, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

January 10, 2018

Status Verified

January 1, 2018

Enrollment Period

3.8 years

First QC Date

July 26, 2013

Last Update Submit

January 8, 2018

Conditions

Keywords

FractureSupracondylarPediatricOrthopedic

Outcome Measures

Primary Outcomes (1)

  • Baumann's Angle

    Baumann's angle of the injured elbow will be measured 6 months following the injury

    6 Months

Secondary Outcomes (2)

  • Humero-Capitellar Angle

    6 Months

  • Functional Outcome Questionnaire

    6 Months

Study Arms (2)

Above Elbow Cast + Collar/cuff

Participants randomized to this group will be treated with an Above Elbow Cast \& collar/cuff for 3 weeks

Procedure: Above Elbow Cast

Long Arms Splint + Collar/Cuff

Participants randomized to this group will be treated with a long arm splint \& collar/cuff for 3 weeks

Procedure: Long Arm Splint

Interventions

Above Elbow Cast + Collar/cuff
Long Arms Splint + Collar/Cuff

Eligibility Criteria

Age3 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Eligible participants will be recruited from the Emergency Department at BC Children's Hospital

You may qualify if:

  • Ages 3-12
  • Type 1 supracondylar fracture

You may not qualify if:

  • A type 2 or 3 supracondylar fracture
  • Neurovascular compromise associated with the fracture
  • Previous diagnosis with a metabolic or structural bone disease
  • Other fractures to ipsilateral upper extremity
  • History of injury to affected elbow

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

Related Publications (1)

  • Siu C, Farrell S, Schaeffer EK, Doan Q, Dobbe A, Bone J, Reilly CW, Mulpuri K. Long-Arm Splinting Versus Above-Elbow Casting for Type 1 Supracondylar Fractures of the Humerus in Children: a Randomized Controlled Trial. SN Compr Clin Med. 2023;5(1):72. doi: 10.1007/s42399-023-01417-z. Epub 2023 Feb 3.

MeSH Terms

Conditions

Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Kishore Mulpuri, MBBS, MS, MHSc

    University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

July 26, 2013

First Posted

July 31, 2013

Study Start

August 1, 2013

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

January 10, 2018

Record last verified: 2018-01

Locations