Bipolar Surgical Release in Congenital Muscular Torticollis

Congenital Muscular Torticollis Clinical Trial

Official title:

Result of Bipolar Surgical Release in Congenital Muscular Torticollis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03562260
• Other study ID #: si049/2013
• Status: Recruiting
• Phase: N/A
• Start date: August 10, 2018
• Est. completion date: August 9, 2019

Study information

• Verified date: June 2018
• Source: Mahidol University
• Contact: Prof.Dr.Kamolporn Kaewpornsawan, MD
• Phone: 660814984227
• Email: kamolporn.kae[@]mahidol.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

the study perform in children with congenital muscular torticollis

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: August 9, 2019
• Est. primary completion date: August 9, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Muscular Torticollis
• Torticollis

Intervention

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

Locations

Country	Name	City	State
Thailand	Prof.Dr.Kamolporn Kaewpornsawan	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	no torticollis after 1 year of surgery