Endoscopic Treatment for Isolated, Single Suture Craniosynostosis

This study has been withdrawn prior to enrollment.

(Study was withdrawn due to lack of resources.)

Sponsor:

Information provided by:

University of Utah

ClinicalTrials.gov Identifier:

NCT00769847

First received: October 7, 2008

Last updated: November 24, 2009

Last verified: November 2009

History of Changes

Purpose

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

Condition	Intervention
Craniosynostosis	Procedure: Endoscopic strip craniectomy

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Endoscopic Treatment for Isolated, Single Suture Craniosynostosis

Resource links provided by NLM:

Genetics Home Reference related topics: Apert syndrome Baller-Gerold syndrome Beare-Stevenson cutis gyrata syndrome branchio-oculo-facial syndrome Crouzon syndrome Crouzonodermoskeletal syndrome Jackson-Weiss syndrome Muenke syndrome Pfeiffer syndrome

MedlinePlus related topics: Endoscopy

U.S. FDA Resources

Further study details as provided by University of Utah:

Estimated Enrollment:	200
Study Start Date:	September 2008
Estimated Study Completion Date:	September 2013
Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Sagittal synostosis Male and female infants from 1-6 months of age with isolated, single suture sagittal craniosynostosis.	Procedure: Endoscopic strip craniectomy Surgery

Eligibility

Ages Eligible for Study:	1 Month to 6 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00769847

Sponsors and Collaborators

University of Utah

Investigators

Principal Investigator:

Faizi Siddiqu, MD

University of Utah

More Information

Publications:

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

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.

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

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.

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

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.

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.

Responsible Party:	Faizi Siddiqi, M.D., Principal Investigator, University of Utah
ClinicalTrials.gov Identifier:	NCT00769847 History of Changes
Other Study ID Numbers:	22034
Study First Received:	October 7, 2008
Last Updated:	November 24, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Utah:

Endoscopic, craniosynostosis, sagittal, synostosis

Additional relevant MeSH terms:

Craniosynostoses
Synostosis
Dysostoses
Bone Diseases, Developmental
Bone Diseases

Musculoskeletal Diseases
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Plagiocephaly
Congenital Abnormalities

ClinicalTrials.gov processed this record on May 23, 2013

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