Vascular CT Assessment of Structural Autograft and Allograft Healing

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00594776

Enrollment

Registered

2008-01-16

Start date

2006-11-30

Completion date

2015-12-31

Last updated

2016-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bone Tumors

Keywords

Cone Beam CT, CBCT, Bone Tumors, Autographs, Allographs

Brief 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.

Interventions

DEVICECone 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

10 Years to 100 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Change in intramedullary vascular volume and new bone growth based on CBCT	2, 8 & 18 months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026