Endoscopic Treatment for Isolated, Single Suture Craniosynostosis

NCT00769847 | Withdrawn

• 1 other identifier: 22034
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Craniosynostosis

Keywords

Endoscopic, craniosynostosis, sagittal, synostosis

Study Arms (1)

Sagittal synostosis

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

Procedure: Endoscopic strip craniectomy

Interventions

Endoscopic strip craniectomy PROCEDURE

Surgery

Sagittal synostosis

Eligibility Criteria

• Age: 1 Month - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Multiple suture craniosynostosis and infants older than 6 months of age.

Sponsors & Collaborators

• University of Utah: lead

Related Publications (8)

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

  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.

  PMID: 14903268 BACKGROUND

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

  BACKGROUND

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

  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.

  PMID: 10323690 BACKGROUND

• 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.

  PMID: 9420076 BACKGROUND

• 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.

  PMID: 15287447 BACKGROUND

• 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.

  PMID: 16398483 BACKGROUND

MeSH Terms

Conditions

Craniosynostoses; Synostosis

Condition Hierarchy (Ancestors)

Dysostoses; Bone Diseases, Developmental; Bone Diseases; Musculoskeletal Diseases; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Faizi Siddiqu, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 7, 2008
• First Posted: October 9, 2008
• Study Start: September 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: September 1, 2013
• Last Updated: June 2, 2015

Record last verified: 2015-05