Vertebral Augmentation With Kyphoplasty vs Nonsurgical Mgmt for Vertebral Body Compression Fractures
|ClinicalTrials.gov Identifier: NCT01175278|
Recruitment Status : Withdrawn (No enrollment)
First Posted : August 4, 2010
Last Update Posted : January 12, 2012
|Condition or disease||Intervention/treatment||Phase|
|Multiple Myeloma||Procedure: Vertebral Augmentation with Balloon Kyphoplasty Other: Non-surgical Treatment||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study of Vertebral Augmentation With Kyphoplasty Versus Nonsurgical Management in Multiple Myeloma Patients With Mildly Symptomatic Vertebral Body Compression Fractures|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
No Intervention: Observation Arm
Patients who are asymptomatic (no symptoms) will participate in the observational portion of the study.
|Experimental: Balloon Kypholasty||
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.
Active Comparator: Control Arm
Non-surgical Management Treatment Group
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).
- Time to Vertebral Event [ Time Frame: Average of 12 months ]Time to vertebral event (composite end point of pain progression, hospitalization for pain, and rescue vertebral augmentation or surgery or radiation therapy as related to an index fracture)
- Time to Pain Progression [ Time Frame: Average of 12 months ]Time to pain progression defined as the time to the development of pain severity rated greater than 4 on the visual analog scale (VAS) as related to an index fracture
- Rate of Vertebral Events [ Time Frame: 12 months ]Rate of vertebral events in patients with asymptomatic vertebral compression fracture at 12 months
- Rate of Hospitalization [ Time Frame: 12 months ]Rate of hospitalization for pain control in patients with asymptomatic or mildly symptomatic vertebral compression fracture at 12 months
- Complications of Procedure [ Time Frame: Average of 12 months ]Complications of vertebral augmentation
- Quality of Life Questionnaire Results [ Time Frame: Average of 12 months ]Quality of life as assessed by the Functional Assessment of Cancer Treatment - General (FACT-G) questionnaire in all enrolled patients and Roland Morris disability questionnaire for spine disability
- Changes in Pulmonary Function [ Time Frame: Average of 12 months ]Changes in pulmonary function testing in patients with thoracic spine vertebral compression fracture
- Change in Kyphosis [ Time Frame: Average of 12 months ]Change in kyphosis as measured by the Cobb method and change in vertebral collapse by the method of Genant
- Prognostic Ability of Bone Biomarkers [ Time Frame: Average of 12 months ]Prognostic ability of bone biomarkers for the prediction of vertebral events
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01175278
|Principal Investigator:||Frank Vrionis, M.D.||H. Lee Moffitt Cancer Center and Research Institute|