Ignite Creation Date:
2024-05-05 @ 10:44 PM
Last Modification Date:
2024-10-26 @ 10:23 AM
Study NCT ID:
NCT01175278
Status:
WITHDRAWN
Last Update Posted:
2012-01-12
First Post:
2010-08-03
Brief Title:
Vertebral Augmentation With Kyphoplasty vs Nonsurgical Mgmt for Vertebral Body Compression Fractures
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Pilot Study of Vertebral Augmentation With Kyphoplasty Versus Nonsurgical Management in Multiple Myeloma Patients With Mildly Symptomatic Vertebral Body Compression Fractures
Status:
WITHDRAWN
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to find out how balloon kyphoplasty surgical repair of the patients 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 11 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Pro00000214 | OTHER | USF Institutional Review Board | None |