NCT01293916

Brief Summary

Prospective randomized controlled trial comparing use of single leg spica with double leg spica casts in the treatment of pediatric femur fractures in children ages 2 through 6 years old.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2006

Typical duration for not_applicable

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

Study Start

First participant enrolled

June 1, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

February 10, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 11, 2011

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

2.6 years

First QC Date

February 10, 2011

Last Update Submit

February 1, 2019

Conditions

Femur Fracture

Keywords

pediatricfemurfemoralfracturespicacastdiaphysealsingledoublepatient age 2 to 6 years old

Outcome Measures

Primary Outcomes (1)

  • Acceptable fracture healing

    evaluation of shortening, angulation, and rotation radiographically at time of fracture healing

    8 weeks

Study Arms (2)

Double leg spica cast

ACTIVE COMPARATOR

The current accepted treatment is the double leg spica cast in the treatment of pediatric diaphyseal femur fractures.

Other: Spica casting

Single leg spica casts

EXPERIMENTAL

The study group is the single leg spica cast group

Other: Spica casting

Interventions

Spica castingOTHER

single versus double leg spica casting

Double leg spica castSingle leg spica casts

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • diaphyseal femur fracture
  • age between 2 and 6 years old

You may not qualify if:

  • underlying bone disorder
  • neuromuscular disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

MeSH Terms

Conditions

Femoral FracturesFractures, Bone

Condition Hierarchy (Ancestors)

Wounds and InjuriesLeg Injuries

Study Officials

  • Dirk Leu, MD

    Johns Hopkins University

    STUDY DIRECTOR

  • Paul D Sponseller, MD MPH

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2011

First Posted

February 11, 2011

Study Start

June 1, 2006

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

February 5, 2019

Record last verified: 2019-02

Locations

US(1)