Vertebral Augmentation With Kyphoplasty vs Nonsurgical Mgmt for Vertebral Body Compression Fractures



Status:Archived
Conditions:Blood Cancer, Orthopedic, Hematology
Therapuetic Areas:Hematology, Oncology, Orthopedics / Podiatry
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:July 2010
End Date:December 2013

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Trial Summary
Trial Overview
Inclusion Criteria

A Pilot Study of Vertebral Augmentation With Kyphoplasty Versus Nonsurgical Management in Multiple Myeloma Patients With Mildly Symptomatic Vertebral Body Compression Fractures


The purpose of this study is to find out how balloon kyphoplasty (surgical repair of the
patient's fracture using balloons and bone cement) compares to non-surgical treatment in
reducing vertebral compression fractures while providing pain relief and improved function
and quality of life.


This is a prospective single center study designed to compare balloon kyphoplasty to
non-surgical management (NSM) in the treatment of mildly painful, acute vertebral body
compression fractures in multiple myeloma patients. Because of the pilot nature and the
small sample size of the study, patient randomization will NOT be stratified. Patients with
mildly symptomatic vertebral compression fractures (VCFs) will undergo a 1:1 randomization
either balloon kyphoplasty or non surgical management. Randomization assignments will be
generated by computer and investigator notified once the patient enrolled.

The observational arm will be compared to each of the other two arms; control and
intervention arm using the same outcome variables and statistical methods.


We found this trial at
1
site
H. Lee Moffitt Cancer Center & Research Institute
12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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mi
from
Tampa, FL
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