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Efficacy of Kyphoplasty With a New Intervertebral Expander

M

Mohammad ARAB MOTLAGH

Status

Completed

Conditions

Vertebral Body Compression

Treatments

Procedure: Kyphoplasty

Study type

Observational

Funder types

Other

Identifiers

NCT03521661
Kyphoplasty

Details and patient eligibility

About

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.

Enrollment

41 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

41 participants in 1 patient group

Kyphoplasty
Description:
Patients underwent kyphoplasty with an intravertebral expander
Treatment:
Procedure: Kyphoplasty

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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