Efficacy of Kyphoplasty With a New Intervertebral Expander

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

41 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2018-03-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Vertebral Body Compression

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Kyphoplasty

Patients underwent kyphoplasty with an intravertebral expander

Kyphoplasty

Intervention Type PROCEDURE

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

Interventions

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Kyphoplasty

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

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No