Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2026-01-03 @ 7:04 PM
Study NCT ID:
NCT01402167
Status:
WITHDRAWN
Last Update Posted:
2015-03-25
First Post:
2011-07-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures
Sponsor:
Centre Hospitalier Universitaire de Nīmes
Organization:
Study Overview
Official Title:
Evaluating Transcutaneous Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures: a Randomized Pilot Study Using Catscan Volumetry
Status:
WITHDRAWN
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Patients refuse randomization.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary objective of this study is to compare the volume of injected ciment (polymethyl methacrylate) between a group of patients treated with vertebroplasty and a group of patients treated via kyphoplasty. Secondary evaluation will compare the restoration of vertebral height, volume and cyphotic angle between the two techniques, as well as extravation of ciment and functional and quality of life aspects related to these techniques.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: