Bipolar Surgical Release in Congenital Muscular Torticollis

June 28, 2018 updated by: Mahidol University

Result of Bipolar Surgical Release in Congenital Muscular Torticollis

The congenital muscular torticollis is common disease in children.The indication for surgery is the children have persist deformity after 1 year old.Many surgical treatment had proposed such as unipolar release and bipolar release.By author experience the bipolar release had better results from complete cut the muscle both origin and insertion.This study wants to study the results of treatment in term of recurrence of the deformity.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

the study perform in children with congenital muscular torticollis

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Recruiting
        • Prof.Dr.Kamolporn Kaewpornsawan
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 13 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 1. all children age ranged from 5-15 years old who received the surgical treatment by bipolar release in the hospital.

Exclusion Criteria:

  • 1. no history of surgery at the neck 2. no history of congenital anomalies and syndrome that effect the neck

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: children who had bipolar release
children who had bipolar release are included
Procedure: bipolar release
the bipolar release is the surgery that cut the origin and insertion of the sternocleidomastoid muscle that cause the torticollis from its contracture

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ImageJ scoring system
Time Frame: no torticollis after 1 year of surgery
measurement from pictures of head and face compared to normal children score 1-3 in 5 measurement in total score of 15 as interval scale score has 4 grade 13-15 is excellent results score 10-12 good result 7-9 fair less than 6 score is poor result after surgery
no torticollis after 1 year of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Prof.Dr.Kamolporn Kaewpornsawan, Department of Orthopaedic Surgery,Faculty of Medicine,Siriraj Hospital,Mahidol University,Bangkok,Thailand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

August 10, 2018

Primary Completion (Anticipated)

August 9, 2019

Study Completion (Anticipated)

August 9, 2019

Study Registration Dates

First Submitted

May 21, 2018

First Submitted That Met QC Criteria

June 7, 2018

First Posted (Actual)

June 19, 2018

Study Record Updates

Last Update Posted (Actual)

July 2, 2018

Last Update Submitted That Met QC Criteria

June 28, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • si049/2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

no sharing IPD data

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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