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CompletedNCT03521661Updated May 22, 2018

Efficacy of Kyphoplasty With a New Intervertebral Expander

An observational study in Vertebral Body Compression, sponsored by Mohammad ARAB MOTLAGH. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-22.

Sponsored by Mohammad ARAB MOTLAGH · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
41
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Vertebral Body Compression

Keywords

  • Vertebral fracture
  • Kyphotic deformity
  • Kyphoplasty
  • Vertebroplasty
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In context

Lead sponsor

Mohammad ARAB MOTLAGH is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with new osteoporotic vertebral body fractures who were eligible for kyphoplasty and were treated with kyphoplasty, were observed prospectively 12 months after the surgery. In the follow-up period the clinical and radiological data were collected

Inclusion criteria

  • Osteoporotic vertebral body fractures that were classified as A1 fractures according to Arbeitsgemeinschaft Osteosynthesis (AO) Classification

Exclusion criteria

Exclusion Criteria:

  • More than 2 vertebral body fractures
  • Fractures of vertebral body based on malignancy
  • Previous spinal operation
  • Spinal infection
  • Spinal deformity (scoliosis)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
41 participants (actual)
Patient registry
No

Groups and cohorts

  • Kyphoplasty

    Patients underwent kyphoplasty with an intravertebral expander

    Procedure: Kyphoplasty

Interventions

  • ProcedureKyphoplasty

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

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What researchers measure

Primary outcomes

  1. Radiological evaluation

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

    Time frame: 12 months

Secondary outcomes

  1. Visual Analogue Scale

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

    Time frame: 12 months

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03521661
Lead sponsor
Mohammad ARAB MOTLAGH
Responsible party
Mohammad ARAB MOTLAGH (MD PhD, Johann Wolfgang Goethe University Hospital) — Sponsor-investigator
First posted
May 11, 2018
Start date
Jan 1, 2014
Primary completion
Oct 1, 2017
Completion
Mar 1, 2018
Last update
May 22, 2018

Study contacts

Mohammad Arab Motlagh, MD, PhD
principal investigator · Goethe University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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