Vascular CT Assessment of Structural Autograft and Allograft Healing

University of Rochester

Status: Completed

Conditions: Bone Tumors

Treatments: Device: Cone Beam CT Scan

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00594776

15198

P50AR054041 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 10 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

8 participants in 1 patient group

1

Description:

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.

Treatment:

Device: Cone Beam CT Scan