Evaluating Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures

Not Applicable

Withdrawn

• Conditions: Vertebral Body Compression Fractures
• Interventions: Procedure: Vertebroplasty; Procedure: Kyphoplasty

• Registration Number: NCT01402167
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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

Not available

Study Timeline

• Study First Submitted: 2011-07-25
• Study First Submitted QC: 2011-07-25
• Study First Posted: 2011-07-26
• Study Start: 2014-09
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-24
• Last Update Posted: 2015-03-25
• Primary Completion: 2016-05
• Study Completion: 2016-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• The patient must have given his/her informed and signed consent
• The patient must be insured or beneficiary of a health insurance plan
• The patient is available for 3 months of follow-up
• Fracture type according to Magerl Classification (1994) must be one of the following: A1, A2.1, A3.1, A3.2
• Cyphose of >10°
• Spinal pain
• Vertebral fracture < 3 weeks old located between D5 and L5
• If fragments in the canal, they must protrude less than 40%
• Absence of other lesions, including cancer

Exclusion Criteria

• The patient is participating in another study
• The patient is in an exclusion period determined by a previous study
• The patient is under judicial protection, under tutorship or curatorship
• The patient refuses to sign the consent
• It is impossible to correctly inform the patient
• Patient cannot read French
• Patient is pregnant or breast feeding
• Patient has a fracture on an adjacent vertebra
• Patient has a contra-indication for a treatment used in this study
• ASA class IV or V
• Patient has a neurological deficit
• Previous spinal surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vertebroplasty	Vertebroplasty	Patients randomized to this arm will be treated via vertebroplasty.
Kyphoplasty	Kyphoplasty	Patients randomized to this arm will be treated via balloon kyphoplasty.

Primary Outcome Measures

Name	Time	Method
The volume (cm^3) of injected ciment	Baseline (Day 0)	The volume of injected ciment is measured by catscan extrapolated data.

Secondary Outcome Measures

Name	Time	Method
The change in the ODI score before and after surgery	3 months	The change in the Oswestry Disability Index before and after surgery
The % change in SF-36 quality of life score before and after surgery	3 months	Percentage change (%) in SF-36 quality of life score before and after surgery
Recovery of vertebral volume (%)	Day 1 to Day 7	Recovery of vertebral volume relative to theoretical volume based on neighboring vertebra.
Change from baseline of the cyphotic angle (°)	3 months	The number of degrees of change in the cyphotic angle of the corrected vertebra relative to baseline measurement (°)
Change from baseline in vertebral height (mm)	3 months	Change in vertebra height (mm) before and after surgery
Volume of ciment leakage (cm^3)	Day 1	The volume of ciment leakage will be determined according to catscan data.
Change in Visual Analog Scale (0 to 10) for pain before and after surgery	3 months	Brute change in Visual Analog Scale (0 to 10) for pain before and after surgery
The % change in the ODI score before and after surgery	3 months	The percentage change (%) in the Oswestry Disability Index before and after surgery
% Change in DPQ score before and after surgery	1 month	Percentage change (%) in the Dallas Pain Questionnaire score before and after surgery
% Change in FABQ score before and after surgery	3 months	Percentage change (%) in the Fear-Avoidance Beliefs Questionnaire score before and after surgery
Presence / absence of post-operative complications	3 months	Presence / absence of post-operative complications
% Change in Visual Analog Scale (0 to 10) for pain before and after surgery	3 months	The percentage change (%) in Visual Analog Scale (0 to 10) for pain before and after surgery
Change in SF-36 quality of life score before and after surgery	3 months	Change in SF-36 quality of life score before and after surgery
Presence / absence of per-operative complications	Day 0 (day of surgery)	Presence / absence of per-operative complications
Change in FABQ score before and after surgery	3 months	Change in the Fear-Avoidance Beliefs Questionnaire score before and after surgery
Change in DPQ score before and after surgery	3 months	Change in the Dallas Pain Questionnaire score before and after surgery
Duration of surgery (minutes)	Day 0 (day of surgery)	Length of operative time (minutes)