99
Participants
Start Date
February 28, 2006
Primary Completion Date
January 31, 2009
Study Completion Date
January 31, 2009
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.
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.
Allegheny General Hospital, Pittsburgh
University of Virginia, Charlottesville
West Virginia University School of Medicine, Morgantown
University of Florida, Gainesville
University of Texas, Houston
Barrow Neurosurgical Institute, Scottsdale
Stanford Medical Center, Stanford
Oregon Health Sciences University, Portland
Synthes USA HQ, Inc.
INDUSTRY