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Vascular CT Assessment of Structural Autograft and Allograft Healing


N/A
10 Years
N/A
Open (Enrolling)
Both
Bone Tumors

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Trial Information

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.


Inclusion Criteria:



- male or female

- all races will be included

- autograft or allograft of long bone as part of treatment for bone tumor

Exclusion Criteria:

- pregnancy

- patients with a history of IV contrast reactions

- contraindication to use of epinephrine or diphenhydramine

- hypertyroidism or history of sensitivity to iodine

- kidney disease (abnormal urinalysis or calculaged GFR) or poor hydration due to poor
intake or other causes

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Change in intramedullary vascular volume and new bone growth based on CBCT

Outcome Time Frame:

2, 8 & 18 months

Safety Issue:

No

Principal Investigator

Edward Schwarz, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Rochester

Authority:

United States: Institutional Review Board

Study ID:

15198

NCT ID:

NCT00594776

Start Date:

November 2006

Completion Date:

January 2014

Related Keywords:

  • Bone Tumors
  • Cone Beam CT
  • CBCT
  • Bone Tumors
  • Autographs
  • Allographs
  • Bone Neoplasms

Name

Location

University of RochesterRochester, New York  14642