NCT00594776

Vascular CT Assessment of Structural Autograft and Allograft Healing

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: University of Rochester · Academic / Other
• Sex: All
• Age: 10 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the ability of a cone beam CT to measure bone healing.

Detailed description

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.

Conditions

• Bone Tumors

Interventions

Type	Name	Description
DEVICE	Cone Beam CT Scan	The Cone Beam Computerized Tomographic (CBCT) device utilizes computerized tomographic technology, a special digital imaging plate and a computer to create a three-dimensional image. The special imaging plate and software allow for small details to be imaged without tissue overlap.

Timeline

• Start date: 2006-11-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2008-01-16
• Last updated: 2016-02-09

Locations

1 site across 1 country: United States