Vascular CT Assessment of Structural Autograft and Allograft Healing

NCT00594776 | Completed

• 2 other identifiers: 15198P50AR054041
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bone Tumors

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  2, 8 & 18 months

Study Arms (1)

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.

Device: Cone Beam CT Scan

Interventions

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.

1

Eligibility Criteria

• Age: 10 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• male or female
• all races will be included
• autograft or allograft of long bone as part of treatment for bone tumor

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Bone Neoplasms

Interventions

Tomography, Spiral Computed

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Tomography, X-Ray Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Edward Schwarz, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 16, 2008
• Study Start: November 1, 2006
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: February 9, 2016

Record last verified: 2016-02

Locations

US (1)