Vascular CT Assessment of Structural Autograft and Allograft Healing

Completed

• Conditions: Bone Tumors
• Interventions: Device: Cone Beam CT Scan

• Registration Number: NCT00594776
• Lead Sponsor: University of Rochester

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.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2008-01-07
• Study First Submitted QC: 2008-01-07
• Study First Posted: 2008-01-16
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-08
• Last Update Posted: 2016-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
1	Cone Beam CT Scan	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.

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Rochester; 🇺🇸 Rochester, New York, United States