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Vascular CT Assessment of Structural Autograft and Allograft Healing

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ClinicalTrials.gov Identifier: NCT00594776
Recruitment Status : Completed
First Posted : January 16, 2008
Last Update Posted : February 9, 2016
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Eddie Schwarz, University of Rochester

Tracking Information
First Submitted Date January 7, 2008
First Posted Date January 16, 2008
Last Update Posted Date February 9, 2016
Study Start Date November 2006
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 7, 2008)
Change in intramedullary vascular volume and new bone growth based on CBCT [ Time Frame: 2, 8 & 18 months ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT00594776 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Vascular CT Assessment of Structural Autograft and Allograft Healing
Official Title Vascular CT Assessment of Structural Autograft and Allograft Healing
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Bone Tumors
Intervention 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.
Study Groups/Cohorts 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.
Intervention: Device: Cone Beam CT Scan
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 8, 2016)
8
Original Estimated Enrollment
 (submitted: January 7, 2008)
20
Actual Study Completion Date December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 10 Years to 100 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00594776
Other Study ID Numbers 15198
P50AR054041 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Eddie Schwarz, University of Rochester
Study Sponsor University of Rochester
Collaborators National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators
Principal Investigator: Edward Schwarz, PhD University of Rochester
PRS Account University of Rochester
Verification Date February 2016