Treatment of Distal Radius Buckle Fractures | NCT01762605

Studies
Treatment of Distal Radius Buckle Fractures

NCT01762605

Sponsor

Wake Forest University

Status

Terminated

Last Update Posted

Mar 7, 2022Actual

Enrollment

11Actual

Phase

Not Applicable

Conditions

Fracture Treatment

Interventions

Supportive Care
Cast

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

Aug 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

inadequate enrollment

Expanded Access Info

Start Date

Mar 2010

Primary Completion Date

Nov 2012Actual

Completion Date

Nov 2012Actual

First Submitted Date

Jan 3, 2013

First Submission Date that Met QC Criteria

Jan 3, 2013

First Posted Date

Jan 8, 2013Estimated

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

Mar 4, 2022

Last Update Posted Date

Mar 7, 2022Actual

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

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.

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

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Supportive Care	Other		Supportive Care
Cast

Measure	Description	Time Frame
Pain		4-6 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
John Frino, MD	Atrium Health Wake Forest Baptist	Principal Investigator

Locations

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D010166	Palliative Care
C119975	POLR1G protein, human

Ancestor Terms

ID	Term
D005791	Patient Care
D013812	Therapeutics
D006296	Health Services
D005159	Health Care Facilities Workforce and Services

Browse Leaves

Not provided

Browse Branches

Not provided