NCT00859508

Study of SyntheCelTM Dura Replacement to Other Dura Replacements

A Prospective, Multi-Center, Randomized, Controlled Clinical Study Comparing SyntheCelTM Dura Replacement to Other Dura Replacements in Patients Requiring Dura Repair Following Cranial Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Synthes USA HQ, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Primary Objective: To demonstrate that the SyntheCelTM Dura Replacement performs similarly to or is substantially equivalent to other dura replacements for the repair of the cranial dura in patients undergoing surgical repair of the cranial dura.

Conditions

• Cranial Dura Repair

Interventions

Type	Name	Description
DEVICE	SyntheCel	Patients will be clinically followed post-surgery until hospital discharge or within ten (10) days of the procedure and at one (1) month, three (3) months and six (6) months. The data up to and including the 6 month follow-up visit will be used in demonstrating the performance of SyntheCelTM Dura Replacement.
DEVICE	Other FDA cleared dura replacements	Patients will be clinically followed post-surgery until hospital discharge or within ten (10) days of the procedure and at one (1) month, three (3) months and six (6) months. The data up to and including the 6 month follow-up visit will be used in demonstrating the performance of SyntheCelTM Dura Replacement.

Timeline

• Start date: 2006-02-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2009-03-11
• Last updated: 2012-03-08
• Results posted: 2012-03-06

Locations

8 sites across 1 country: United States