Carrying Angle From Birth to Adolescents | NCT03546348

Studies
Carrying Angle From Birth to Adolescents

NCT03546348

Sponsor

Mahidol University

Status

Unknown status

Last Update Posted

Jun 6, 2018Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Birth

Interventions

no intervention

Countries

Thailand

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

Jun 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2018Estimated

Primary Completion Date

May 31, 2019Estimated

Completion Date

May 31, 2019Estimated

First Submitted Date

May 17, 2018

First Submission Date that Met QC Criteria

Jun 1, 2018

First Posted Date

Jun 6, 2018Actual

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

Jun 1, 2018

Last Update Posted Date

Jun 6, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

The carrying angle in the elbow in children is very important.Most of the results of treatment in fracture around the elbow have to measure the carrying angle.The common deformity of the elbow from cubitus varus is the change of the carrying of the elbow.There are many researches studied in normal value of the carrying angle but few had study the carrying angle from birth to adolescent.This study want to compare the carrying angle in different age and gain the knowledge of development of the carrying angle in children

Detailed Description

The study is to measure the carrying angle of the children from birth to adolescents

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention	Other	only measurement of the carrying angle

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
carrying angle	the angle between the arm and forearm in full extension and supination of the elbow	1 year

Secondary Outcomes

Measure	Description	Time Frame
age	age count in year	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

normal children age 0 day to 16 years old
Thai nationality

Exclusion Criteria:

no history of fracture around the elbow or upper extremity
no congenital anomalies or abnormal bone that interfere the upper extremity
no genetic diseases and skeletal dysplasia
no deformity of the elbow or upper extremity
refuse to enrolled in the study

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

16 Years

Standard Ages

Child

Study Population

-all normal children who are in Bangkok are enrolled in the study .There are 17 groups start from 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 and 16 years old including both sex.

each group has 15 boys and 15 girls All are measured the carrying angle in both right and left elbow in full extension and supination

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Prof.Dr.Kamolporn Kaewpornsawan, MD	Contact	660814984227		kamolporn.kae@mahidol.ac.th

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prof.Dr.Kamolporn Kaewpornsawan	Recruiting	Bangkok		10700	Thailand

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
4479296	Background	Baughman FA Jr, Higgins JV, Wadsworth TG, Demaray MJ. The carrying angle in sex chromosome anomalies. JAMA. 1974 Nov 4;230(5):718-20. No abstract available.
16280718	Background	Balasubramanian P, Madhuri V, Muliyil J. Carrying angle in children: a normative study. J Pediatr Orthop B. 2006 Jan;15(1):37-40. doi: 10.1097/01202412-200601000-00008.