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Vascular CT Assessment of Structural Autograft and Allograft Healing

This study has been completed.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Eddie Schwarz, University of Rochester Identifier:
First received: January 7, 2008
Last updated: February 8, 2016
Last verified: February 2016
The purpose of this study is to determine the ability of a cone beam CT to measure bone healing.

Condition Intervention
Bone Tumors
Device: Cone Beam CT Scan

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Vascular CT Assessment of Structural Autograft and Allograft Healing

Resource links provided by NLM:

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Change in intramedullary vascular volume and new bone growth based on CBCT [ Time Frame: 2, 8 & 18 months ]

Enrollment: 8
Study Start Date: November 2006
Study Completion Date: December 2015
Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
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.

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.

Ages Eligible for Study:   10 Years to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients are recruited from the general practice of 3 of our investigators. Patients will have received an structural allograft or vascularized autograft for the treatment of bone cancer.

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00594776

United States, New York
University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator: Edward Schwarz, PhD University of Rochester
  More Information

Responsible Party: Eddie Schwarz, Professor, University of Rochester Identifier: NCT00594776     History of Changes
Other Study ID Numbers: 15198
P50AR054041 ( US NIH Grant/Contract Award Number )
Study First Received: January 7, 2008
Last Updated: February 8, 2016

Keywords provided by University of Rochester:
Cone Beam CT
Bone Tumors

Additional relevant MeSH terms:
Bone Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases processed this record on May 24, 2017