Bipolar Surgical Release in Congenital Muscular Torticollis

NCT03562260 | Unknown DMC

• 1 other identifier: si049/2013
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Muscular Torticollis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

children who had bipolar release

EXPERIMENTAL

children who had bipolar release are included

Procedure: bipolar release

Interventions

bipolar release PROCEDURE

the bipolar release is the surgery that cut the origin and insertion of the sternocleidomastoid muscle that cause the torticollis from its contracture

children who had bipolar release

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Prof.Dr.Kamolporn Kaewpornsawan

Bangkok, 10700, Thailand

RECRUITING

Related 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. doi: 10.1097/01241398-198609000-00011.

  PMID: 3760169 BACKGROUND

• 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.

  PMID: 21629376 BACKGROUND

• 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.

  PMID: 18591606 BACKGROUND

MeSH Terms

Conditions

Congenital torticollis

Study Officials

• Prof.Dr.Kamolporn Kaewpornsawan

  Department of Orthopaedic Surgery,Faculty of Medicine,Siriraj Hospital,Mahidol University,Bangkok,Thailand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Prof.Dr.Kamolporn Kaewpornsawan, MD

CONTACT

660814984227; kamolporn.kae@mahidol.ac.th

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: only 1 group in children who received the bipolar release

Study Record Dates

• First Submitted: May 21, 2018
• First Posted: June 19, 2018
• Study Start: August 10, 2018
• Primary Completion: August 9, 2019
• Study Completion: August 9, 2019
• Last Updated: July 2, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)