Back to resultsBipolar Surgical Release in Congenital Muscular Torticollis
Primary Purpose
Congenital Muscular Torticollis
Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
bipolar release
Sponsored by
About this trial
This is an interventional treatment trial for Congenital Muscular Torticollis
Eligibility Criteria
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
Sites / Locations
- Prof.Dr.Kamolporn KaewpornsawanRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
children who had bipolar release
Arm Description
children who had bipolar release are included
Outcomes
Primary Outcome Measures
ImageJ scoring system
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03562260
Brief Title
Bipolar Surgical Release in Congenital Muscular Torticollis
Official Title
Result of Bipolar Surgical Release in Congenital Muscular Torticollis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 10, 2018 (Anticipated)
Primary Completion Date
August 9, 2019 (Anticipated)
Study Completion Date
August 9, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
Detailed Description
the study perform in children with congenital muscular torticollis
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Muscular Torticollis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
only 1 group in children who received the bipolar release
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
children who had bipolar release
Arm Type
Experimental
Arm Description
children who had bipolar release are included
Intervention Type
Procedure
Intervention Name(s)
bipolar release
Intervention Description
the bipolar release is the surgery that cut the origin and insertion of the sternocleidomastoid muscle that cause the torticollis from its contracture
Primary Outcome Measure Information:
Title
ImageJ scoring system
Description
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
Time Frame
no torticollis after 1 year of surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Prof.Dr.Kamolporn Kaewpornsawan, MD
Phone
660814984227
Email
kamolporn.kae@mahidol.ac.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof.Dr.Kamolporn Kaewpornsawan
Organizational Affiliation
Department of Orthopaedic Surgery,Faculty of Medicine,Siriraj Hospital,Mahidol University,Bangkok,Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prof.Dr.Kamolporn Kaewpornsawan
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof.Dr.Kamolporn kaewpornsawan, MD.
Phone
(66)024197968
Ext
127
Email
kamolporn.kae@mahidol.ac.th
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
no sharing IPD data
Citations:
PubMed Identifier
3760169
Citation
Lee EH, Kang YK, Bose K. Surgical correction of muscular torticollis in the older child. J Pediatr Orthop. 1986 Sep-Oct;6(5):585-9. doi: 10.1097/01241398-198609000-00011.
Results Reference
background
PubMed Identifier
21629376
Citation
Sudesh P, Bali K, Mootha AK, Dhillon MS. Results of bipolar release in the treatment of congenital muscular torticolis in patients older than 10 years of age. J Child Orthop. 2010 Jun;4(3):227-32. doi: 10.1007/s11832-010-0254-x. Epub 2010 Mar 26.
Results Reference
background
PubMed Identifier
18591606
Citation
Shim JS, Jang HP. Operative treatment of congenital torticollis. J Bone Joint Surg Br. 2008 Jul;90(7):934-9. doi: 10.1302/0301-620X.90B7.20339.
Results Reference
background
Learn more about this trial
Bipolar Surgical Release in Congenital Muscular Torticollis
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