Vertebral Body Compression
Conditions
Keywords
Vertebral fracture, Kyphotic deformity, Kyphoplasty, Vertebroplasty
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.
Interventions
PROCEDUREKyphoplasty
Fractured vertebral body was reduced with an intravertebral expander and was cement augmented thereafter
Sponsors
Mohammad ARAB MOTLAGH
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Radiological evaluation | 12 months | Kyphosis angle in degree and vertebral body height in cm are measured on lateral x-ray |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analogue Scale | 12 months | Scores range from 0 (no pain) to 10 (worst possible pain) |
Outcome results
None listed