Vascular CT Assessment of Structural Autograft and Allograft Healing
The purpose of this study is to investigate quantitative vascular cone beam CT(CBCT) in a
clinical pilot of patients that have received a structural allograft for bone cancer or a
vascularized structural autograft for bone cancer or traumatic injury. Development of a
minimally invasive, longitudinal outcome measure to quantify intramedullary vascular volume
and cortical bone volume of structural allografts in patients is required to translate
"revitalizing" structural allograft in clinical trials. Our novel vascular CBCT will be
able to demonstrate the significant differences between vascularized fibular autografts vs.
structural allografts in patients that will undergo structural grafting. These data will be
used to devise a power calculation for a definitive clinical trial to evaluate the efficacy
of the revitalizing allograft.
Observational
Observational Model: Cohort, Time Perspective: Prospective
Change in intramedullary vascular volume and new bone growth based on CBCT
2, 8 & 18 months
No
Edward Schwarz, PhD
Principal Investigator
University of Rochester
United States: Institutional Review Board
15198
NCT00594776
November 2006
January 2014
Name | Location |
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University of Rochester | Rochester, New York 14642 |