Endoscopic Treatment for Isolated, Single Suture Craniosynostosis

NCT ID: NCT00769847

Last Updated: 2015-06-02

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2008-09-30

Study Completion Date

2013-09-30

Brief Summary

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This is a prospective study to evaluate outcomes in patients undergoing endoscopic craniectomy for isolated, single-suture craniosynostosis.

Detailed Description

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Conditions

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Craniosynostosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sagittal synostosis

Male and female infants from 1-6 months of age with isolated, single suture sagittal craniosynostosis.

Endoscopic strip craniectomy

Intervention Type PROCEDURE

Surgery

Interventions

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Endoscopic strip craniectomy

Surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Infants 1 to 6 months of age with isolated, single-suture craniosynostosis.

Exclusion Criteria

* Multiple suture craniosynostosis and infants older than 6 months of age.
Minimum Eligible Age

1 Month

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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University of Utah

Principal Investigators

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Faizi Siddiqu, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

References

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Obrien MO, Johnson M: Craniosynostosis, in Youmans JR (ed): Neurological Surgery, Philadelphia: WB Saunders, 1990, Vol 2, p 1328.

Reference Type BACKGROUND

HAAS LL. Roentgenological skull measurements and their diagnostic applications. Am J Roentgenol Radium Ther Nucl Med. 1952 Feb;67(2):197-209. No abstract available.

Reference Type BACKGROUND
PMID: 14903268 (View on PubMed)

Lannelongue M. De la craniectomie dans la microcephalie. Compt Rend Seances Acad Sci 50:1382-1385, 1890.

Reference Type BACKGROUND

Lane LC. Pioneer craniectomy for the relief of mental imbecility due to premature sutural closure and microcephalus. JAMA 18:49-50, 1892.

Reference Type BACKGROUND

Panchal J, Marsh JL, Park TS, Kaufman B, Pilgram T, Huang SH. Sagittal craniosynostosis outcome assessment for two methods and timings of intervention. Plast Reconstr Surg. 1999 May;103(6):1574-84. doi: 10.1097/00006534-199905060-00004.

Reference Type BACKGROUND
PMID: 10323690 (View on PubMed)

Jimenez DF, Barone CM. Endoscopic craniectomy for early surgical correction of sagittal craniosynostosis. J Neurosurg. 1998 Jan;88(1):77-81. doi: 10.3171/jns.1998.88.1.0077.

Reference Type BACKGROUND
PMID: 9420076 (View on PubMed)

Jimenez DF, Barone CM, McGee ME, Cartwright CC, Baker CL. Endoscopy-assisted wide-vertex craniectomy, barrel stave osteotomies, and postoperative helmet molding therapy in the management of sagittal suture craniosynostosis. J Neurosurg. 2004 May;100(5 Suppl Pediatrics):407-17. doi: 10.3171/ped.2004.100.5.0407.

Reference Type BACKGROUND
PMID: 15287447 (View on PubMed)

Murad GJ, Clayman M, Seagle MB, White S, Perkins LA, Pincus DW. Endoscopic-assisted repair of craniosynostosis. Neurosurg Focus. 2005 Dec 15;19(6):E6. doi: 10.3171/foc.2005.19.6.7.

Reference Type BACKGROUND
PMID: 16398483 (View on PubMed)

Other Identifiers

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22034

Identifier Type: -

Identifier Source: org_study_id

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