NCT03546348

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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

May 17, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

June 1, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 6, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

June 6, 2018

Status Verified

June 1, 2018

Enrollment Period

12 months

First QC Date

May 17, 2018

Last Update Submit

June 1, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • carrying angle

    the angle between the arm and forearm in full extension and supination of the elbow

    1 year

Secondary Outcomes (1)

  • age

    1 year

Interventions

only measurement of the carrying angle

Eligibility Criteria

Age1 Day - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • normal children age 0 day to 16 years old
  • Thai nationality

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prof.Dr.Kamolporn Kaewpornsawan

Bangkok, 10700, Thailand

RECRUITING

Related Publications (3)

  • 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.

    PMID: 4479296BACKGROUND
  • 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.

    PMID: 16280718BACKGROUND
  • Beals RK. The normal carrying angle of the elbow. A radiographic study of 422 patients. Clin Orthop Relat Res. 1976 Sep;(119):194-6.

    PMID: 954311BACKGROUND

Central Study Contacts

Prof.Dr.Kamolporn Kaewpornsawan, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2018

First Posted

June 6, 2018

Study Start

June 1, 2018

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

June 6, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

no sharing of the IPD data

Locations