Bipolar Surgical Release in Congenital Muscular Torticollis

NCT ID: NCT03562260

Last Updated: 2018-07-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-10

Study Completion Date

2019-08-09

Brief Summary

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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

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the study perform in children with congenital muscular torticollis

Conditions

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Congenital Muscular Torticollis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

only 1 group in children who received the bipolar release
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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children who had bipolar release

children who had bipolar release are included

Group Type EXPERIMENTAL

bipolar release

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Prof.Dr.Kamolporn Kaewpornsawan

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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Prof.Dr.Kamolporn Kaewpornsawan

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Prof.Dr.Kamolporn Kaewpornsawan, MD

Role: CONTACT

660814984227

Facility Contacts

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Prof.Dr.Kamolporn kaewpornsawan, MD.

Role: primary

(66)024197968 ext. 127

References

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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.

Reference Type BACKGROUND
PMID: 3760169 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21629376 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18591606 (View on PubMed)

Other Identifiers

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si049/2013

Identifier Type: -

Identifier Source: org_study_id

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