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

Not Applicable

Completed

• Conditions: Vertebral Body Fracture
• Interventions: Procedure: Vertebroplasty; Procedure: Cavuplasty

• Registration Number: NCT02557113
• Lead Sponsor: Mohammad ARAB MOTLAGH

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2012-09
• Study Completion: 2013-01
• Status Verified: 2015-09
• Study First Submitted: 2015-09-20
• Study First Submitted QC: 2015-09-21
• Last Update Submitted: 2015-09-21
• Study First Posted: 2015-09-23
• Last Update Posted: 2015-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vertebroplasty	Vertebroplasty	This Group Underwent the Vertebroplasty Procedure (Injection of Bone Cement into the Fractured Osteoporotic Vertebral Body)
Cavuplasty	Cavuplasty	This Group Underwent the Cavuplasty Procedure (Small Cavity was Created in the Vertebral Body Prior to Injection of Bone Cement)

Primary Outcome Measures

Name	Time	Method
CT-Scan evaluation	One week	Number of Cement Extravasation in each Vertebral Body

Secondary Outcome Measures

Name	Time	Method
Visual Analogue Scale	3 Months	Scores range from 0 (no pain) to 10 (worst possible pain)