Vascular CT Assessment of Structural Autograft and Allograft Healing

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2015-12-31

Brief Summary

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

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Detailed Description

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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

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Bone Tumors

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Patients who have received a structrual allograft or vascularized fibular autograft surgery to reconstruct their tibia, femur, ulna/radius or humerus for treatment of a bone tumor.

Cone Beam CT Scan

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

10 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No