Evaluating Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures

Evaluating Transcutaneous Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures: a Randomized Pilot Study Using Catscan Volumetry

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.

Study Overview

• Status: Withdrawn
• Conditions: Vertebral Body Compression Fractures
• Intervention / Treatment: Procedure: Kyphoplasty; Procedure: Vertebroplasty

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kyphoplasty; Patients randomized to this arm will be treated via balloon kyphoplasty.	Procedure: Kyphoplasty; Patients will be treated via a balloon kyphoplasty surgical procedure
Active Comparator: Vertebroplasty; Patients randomized to this arm will be treated via vertebroplasty.	Procedure: Vertebroplasty; Patients will be treated via a transcutaneous vertebroplasty procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The volume (cm^3) of injected ciment	The volume of injected ciment is measured by catscan extrapolated data.	Baseline (Day 0)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Pascal Kouyoumdjian, MD, Centre Hospitalier Universitaire de Nîmes

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Anticipated): May 1, 2016
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: July 25, 2011
• First Submitted That Met QC Criteria: July 25, 2011
• First Posted (Estimate): July 26, 2011

Study Record Updates

• Last Update Posted (Estimate): March 25, 2015
• Last Update Submitted That Met QC Criteria: March 24, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Fractures, Bone; Fractures, Compression
• Other Study ID Numbers: LOCAL/2011/PK-04