NCT01175278

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: H. Lee Moffitt Cancer Center and Research Institute · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Multiple Myeloma

Interventions

Type	Name	Description
PROCEDURE	Vertebral Augmentation with Balloon Kyphoplasty	Two small metal tubes will be inserted through the skin into the collapsed bone. Inflatable bone tamps (balloon catheters) will be inserted through each of these two tubes into the bone. The balloons will be inflated with a liquid that can be seen on xrays (contrast) to return the bone toward its natural shape and create a cavity. The balloons will then be deflated and removed. The cavity in the bone will be filled with bone cement to stabilize the broken backbone.
OTHER	Non-surgical Treatment	Non-surgical treatment means the institution of therapies other than cancer chemotherapy and surgical treatment aimed at alleviation of back pain and restoration of decreased function associated with the patient's VCF(s).

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2010-08-04
• Last updated: 2012-01-12