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Completed

NCT Number: NCT00594776

Vascular CT Assessment of Structural Autograft and Allograft Healing

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

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Key information

Age range

10 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Rochester

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cone Beam CT Scan

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.

Primary outcomes

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

    Time frame: 2, 8 & 18 months

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Registry information

Important dates

Study start
2006
Primary completion
2015
Study completion
2015
First posted
Jan 16, 2008
Registry last updated
Feb 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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