BirthNCT03546348
Carrying Angle From Birth to Adolescents
An observational study of Birth, run by Mahidol University at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 day to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Birth
- How many people
- 30 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2018to 31 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 16 years
- All sexes
- Healthy volunteers accepted
- 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
Who may be able to join
- normal children age 0 day to 16 years old
- Thai nationality
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Prof.Dr.Kamolporn Kaewpornsawan
Bangkok, 10700
Prof.Dr.Kamolporn kaewpornsawan, MD., (66)024197968 ext. 127, kamolporn.kae@mahidol.ac.th
About this study
Official title: Normal Value of Carrying Angle in the Elbow From Birth to Adolescents
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
Read the detailed description
The study is to measure the carrying angle of the children from birth to adolescents
- Conditions
- Birth
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
only measurement of the carrying angle
What is being measured
The primary outcome is the main question the study is designed to answer.
carrying angle
the angle between the arm and forearm in full extension and supination of the elbow
Measured: 1 year
Secondary outcomes (1)
age
age count in year
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2018
- Study start1 Jun 2018 (estimated)
- Primary completion31 May 2019 (estimated)
- Study completion31 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03546348
- Sponsor's protocol ID
- si684/2013
- Status last verified
- Jun 2018
- First submitted
- 17 May 2018
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no sharing of the IPD data
Publications
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.
PubMed 4479296Balasubramanian 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.
PubMed 16280718Beals RK. The normal carrying angle of the elbow. A radiographic study of 422 patients. Clin Orthop Relat Res. 1976 Sep;(119):194-6.
PubMed 954311
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normal Value of Carrying Angle in the Elbow From Birth to Adolescents
- ClinicalTrials.gov ID
- NCT03546348
- Acronym / sponsor ID
- si684/2013
- Conditions
- Birth
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (estimated)
- Primary completion
- 31 May 2019 (estimated)
- Study completion
- 31 May 2019 (estimated)
- First posted
- 6 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 day to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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
Key inclusion criteria (2 listed)
- normal children age 0 day to 16 years old
- Thai nationality
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no interventiononly measurement of the carrying angle | Other | – |
Primary outcome
carrying angle
Time frame: 1 year
the angle between the arm and forearm in full extension and supination of the elbow
1 secondary outcome
age
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Background: PubMed 4479296Baughman 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.
- Background: PubMed 16280718Balasubramanian 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.
- Background: PubMed 954311Beals RK. The normal carrying angle of the elbow. A radiographic study of 422 patients. Clin Orthop Relat Res. 1976 Sep;(119):194-6.
- Individual participant dataSharing planned: No. no sharing of the IPD data
Related trials for Birth
Not yet recruiting
Mandala Coloring in Late Pregnancy
Pregnancy, Anxiety
RecruitingPhase 2
A Proof-Of-Concept (POC) Study of SFG-02 Transdermal Formulation in Participants With Underactive Bladder (UAB)
Participants With Underactive Bladder (UAB)
RecruitingObservational study
Prevalence of Pain During Cesarean Section
Cesarean Birth
Recruiting
The Ophthalmic Artery Doppler Evaluation Prior to Labor Induction and Adverse Intrapartum Fetal Outcomes
Ophthalmic Artery, Labor and Delivery
Not yet recruiting
Health-Related Social Needs Food Boxes Delivery Program
Food Insecurity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Birth, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Prof.Dr.Kamolporn Kaewpornsawan, MD (660814984227, kamolporn.kae@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
carrying angle (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03546348, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2018.