Efficacy of Kyphoplasty With a New Intervertebral Expander

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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Key information

Conditions

Vertebral Body Compression Back Injuries Fractures, Bone Spinal Fractures Spinal Injuries Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Kyphoplasty

Procedure

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

Primary outcomes

Radiological evaluation

Time frame: 12 months

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

Secondary outcomes

Visual Analogue Scale

Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Mohammad ARAB MOTLAGH

Other

Registry information

Official study title

Efficacy of Kyphoplasty With an Intravertebral Expander for Correction of Spine Deformity After Osteoporotic Vertebral Fracture

Important dates

Study start: 2014
Primary completion: 2017
Study completion: 2018
First posted: May 11, 2018
Registry last updated: May 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed