Efficacy of Kyphoplasty With a New Intervertebral Expander

Mohammad ARAB MOTLAGH41 enrolled

Overview

Balloon kyphoplasty is a well-established treatment option to achieve pain relief and to correct kyphotic deformity caused by osteoporotic vertebral compression fracture. However, it has been demonstrated that reduction is partly lost as balloon is deflated in the vertebral body. An intravertebral expander was developed for better reduction and maintenance of vertebral body height while cement is injected. This study evaluates the efficacy of kyphoplasty with a new intravertebral expander with regard to correction of kyphosis angel and to restoration of vertebral body height.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Vertebral Body Compression

Interventions

KyphoplastyPROCEDURE

Fractured vertebral body was reduced with an intravertebral expander and was cement augmented thereafter

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Osteoporotic vertebral body fractures 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

Radiological evaluation

Kyphosis angle in degree and vertebral body height in cm are measured on lateral x-ray

Time frame: 12 months

Secondary Outcomes

Visual Analogue Scale

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

Time frame: 12 months

Data from ClinicalTrials.gov

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