NCT01762605

Brief Summary

This study determines if patients with buckle fractures of the distal radius and/or ulna treated with supportive care only demonstrate non-inferior outcomes in regard to pain control during healing, functional outcome at the wrist joint, and parental satisfaction, when compared with patients treated with the standard treatment regimen of 3-4 weeks in a short arm cast.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2010

Typical duration for not_applicable

Status
terminated

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

March 1, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 3, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 8, 2013

Completed
Last Updated

March 7, 2022

Status Verified

August 1, 2018

Enrollment Period

2.7 years

First QC Date

January 3, 2013

Last Update Submit

March 4, 2022

Conditions

Fracture Treatment

Outcome Measures

Primary Outcomes (1)

  • Pain

    4-6 weeks

Study Arms (2)

Supportive Care

EXPERIMENTAL

No casting or splinting, supportive care only by parents

Other: Supportive Care

Cast

ACTIVE COMPARATOR

Casting for 4 weeks

Procedure: Cast

Interventions

Supportive CareOTHER
Supportive Care
CastPROCEDURE
Cast

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children age 1-17 with buckle fractures of the distal radius and/or ulna. -

You may not qualify if:

  • Patients are excluded if there is any other injury to the upper limb or serious bodily trauma that might complicate pain scores. Children with suspected or proven metabolic bone disease, or pathologic fractures are excluded due to resultant abnormal bone healing.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Palliative CarePOLR1G protein, human

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • John Frino, MD

    Atrium Health Wake Forest Baptist

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 3, 2013

First Posted

January 8, 2013

Study Start

March 1, 2010

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

March 7, 2022

Record last verified: 2018-08