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

Mohammad ARAB MOTLAGH

Status: Completed

Conditions: Vertebral Body Fracture

Treatments: Procedure: Cavuplasty; Procedure: Vertebroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT02557113

Cavuplasty

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

Vertebroplasty

Active Comparator group

Description:

This Group Underwent the Vertebroplasty Procedure (Injection of Bone Cement into the Fractured Osteoporotic Vertebral Body)

Treatment:

Procedure: Vertebroplasty

Cavuplasty

Experimental group

Description:

This Group Underwent the Cavuplasty Procedure (Small Cavity was Created in the Vertebral Body Prior to Injection of Bone Cement)

Treatment:

Procedure: Cavuplasty