Creation of a Small Cavity Reduces the Rate of Cement Leakage During Vertebral Body Augmentation

Mohammad ARAB MOTLAGH36 enrolled

Overview

Leakage of polymethylmethacrylate (PMMA) is the most common complication during vertebral body augmentation and can lead to serious patient morbidity. Any measure to reduce the rate of cement leakage is of value and makes the procedure safer.The aim of this study was to investigate the effect of the creation of a cavity on cement leakage during vertebroplasty. Investigators tested the hypothesis that the creation of a merely small and irregular cavity in vertebral body prior to cement injection would reduce cement leakage.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Vertebral Body Fracture

Interventions

VertebroplastyPROCEDURE

Fractured Osteoporotic Vertebral Body is Augmented with Injection of Bone Cement

CavuplastyPROCEDURE

Small Cavity is Created in Fractured Osteoporotic Vertebral Body Prior to Cement Injection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Osteoporotic vertebral body fractures of the thoracolumbar spine (T9 to L4) that were classified as A1 fractures according to Arbeitsgemeinschaft Osteosynthesis (AO) Classification Exclusion Criteria: * More Than 2 Vertebral Body Fractures * Fractures of Vertebral Body Based on Malignancy * Previous Spinal Operation * Spinal Infection * Spinal Deformity (scoliosis)

Outcomes

Primary Outcomes

CT-Scan evaluation

Number of Cement Extravasation in each Vertebral Body

Time frame: One week

Secondary Outcomes

Visual Analogue Scale

Scores range from 0 (no pain) to 10 (worst possible pain)

Time frame: 3 Months

Data from ClinicalTrials.gov

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