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

Creation of a Small Cavity in Vertebral Body Reduces the Rate of Cement Leakage During Vertebral Body Augmentation: A Prospective Randomized Controlled Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02557113

Enrollment

Registered

2015-09-23

Start date

2011-01-31

Completion date

2013-01-31

Last updated

2015-09-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vertebral Body Fracture

Keywords

cement leakage, cement augmentation, vertebral body fracture, vertebral cavity, vertebroplasty

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.

Interventions

PROCEDUREVertebroplasty

Fractured Osteoporotic Vertebral Body is Augmented with Injection of Bone Cement

PROCEDURECavuplasty

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

Measure	Time frame	Description
CT-Scan evaluation	One week	Number of Cement Extravasation in each Vertebral Body

Secondary

Measure	Time frame	Description
Visual Analogue Scale	3 Months	Scores range from 0 (no pain) to 10 (worst possible pain)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026