Evaluating Vertebroplasty and Kyphoplasty for Reducing Trauma-related Fractures

Centre Hospitalier Universitaire de Nīmes

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Conditions

Vertebral Body Compression Fractures

Interventions

KyphoplastyPROCEDURE

Patients will be treated via a balloon kyphoplasty surgical procedure

VertebroplastyPROCEDURE

Patients will be treated via a transcutaneous vertebroplasty procedure.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The volume (cm^3) of injected ciment

The volume of injected ciment is measured by catscan extrapolated data.

Time frame: Baseline (Day 0)

Secondary Outcomes

Recovery of vertebral volume (%)

Recovery of vertebral volume relative to theoretical volume based on neighboring vertebra.

Time frame: 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 (°)

Time frame: 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 (°)

Time frame: 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 (°)

Time frame: 3 months

Change from baseline in vertebral height (mm)

Change in vertebra height (mm) before and after surgery

Time frame: Days 1 to 7

Change from baseline in vertebral height (mm)

Change in vertebra height (mm) before and after surgery

Time frame: 1 month

Change from baseline in vertebral height (mm)

Change in vertebra height (mm) before and after surgery

Data from ClinicalTrials.gov

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Time frame: 3 months

Volume of ciment leakage (cm^3)

The volume of ciment leakage will be determined according to catscan data.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 3 months

The change in the ODI score before and after surgery

The change in the Oswestry Disability Index before and after surgery

Time frame: 3 months

The % change in the ODI score before and after surgery

The percentage change (%) in the Oswestry Disability Index before and after surgery

Time frame: 3 months

Change in SF-36 quality of life score before and after surgery

Time frame: 1 month

Change in SF-36 quality of life score before and after surgery

Time frame: 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

Time frame: 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

Time frame: 3 months

Change in FABQ score before and after surgery

Change in the Fear-Avoidance Beliefs Questionnaire score before and after surgery

Time frame: 1 month

Change in FABQ score before and after surgery

Change in the Fear-Avoidance Beliefs Questionnaire score before and after surgery

Time frame: 3 months

% Change in FABQ score before and after surgery

Percentage change (%) in the Fear-Avoidance Beliefs Questionnaire score before and after surgery

Time frame: 1 month

% Change in FABQ score before and after surgery

Percentage change (%) in the Fear-Avoidance Beliefs Questionnaire score before and after surgery

Time frame: 3 months

Change in DPQ score before and after surgery

Change in the Dallas Pain Questionnaire score before and after surgery

Time frame: 1 month

Change in DPQ score before and after surgery

Change in the Dallas Pain Questionnaire score before and after surgery

Time frame: 3 months

% Change in DPQ score before and after surgery

Percentage change (%) in the Dallas Pain Questionnaire score before and after surgery

Time frame: 3 months

% Change in DPQ score before and after surgery

Percentage change (%) in the Dallas Pain Questionnaire score before and after surgery

Time frame: 1 month

Duration of surgery (minutes)

Length of operative time (minutes)

Time frame: Day 0 (day of surgery)

Presence / absence of per-operative complications

Time frame: Day 0 (day of surgery)

Presence / absence of post-operative complications

Time frame: 1 month

Presence / absence of post-operative complications

Time frame: 3 months