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

NAWithdrawnINTERVENTIONAL
0
Timeline

Start Date

July 31, 2010

Primary Completion Date

May 31, 2011

Study Completion Date

May 31, 2011

Conditions
Multiple Myeloma
Interventions
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).

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Medtronics, Inc.

INDUSTRY

lead

H. Lee Moffitt Cancer Center and Research Institute

OTHER