Efficacy of Kyphoplasty With a New Intervertebral Expander
Completed
- Conditions
- Vertebral Body Compression
- Interventions
- Procedure: Kyphoplasty
- Registration Number
- NCT03521661
- Lead Sponsor
- Mohammad ARAB MOTLAGH
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 41
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)
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Kyphoplasty Kyphoplasty Patients underwent kyphoplasty with an intravertebral expander
- Primary Outcome Measures
Name Time Method Radiological evaluation 12 months Kyphosis angle in degree and vertebral body height in cm are measured on lateral x-ray
- Secondary Outcome Measures
Name Time Method Visual Analogue Scale 12 months Scores range from 0 (no pain) to 10 (worst possible pain)