Efficacy of Kyphoplasty With a New Intervertebral Expander
1 other identifier
observational
41
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2014
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedFirst Submitted
Initial submission to the registry
April 30, 2018
CompletedFirst Posted
Study publicly available on registry
May 11, 2018
CompletedMay 22, 2018
May 1, 2018
3.8 years
April 30, 2018
May 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Radiological evaluation
Kyphosis angle in degree and vertebral body height in cm are measured on lateral x-ray
12 months
Secondary Outcomes (1)
Visual Analogue Scale
12 months
Study Arms (1)
Kyphoplasty
Patients underwent kyphoplasty with an intravertebral expander
Interventions
Fractured vertebral body was reduced with an intravertebral expander and was cement augmented thereafter
Eligibility Criteria
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
You may qualify if:
- Osteoporotic vertebral body fractures that were classified as A1 fractures according to Arbeitsgemeinschaft Osteosynthesis (AO) Classification
You may not qualify if:
- More than 2 vertebral body fractures
- Fractures of vertebral body based on malignancy
- Previous spinal operation
- Spinal infection
- Spinal deformity (scoliosis)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohammad Arab Motlagh, MD, PhD
Goethe University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
April 30, 2018
First Posted
May 11, 2018
Study Start
January 1, 2014
Primary Completion
October 1, 2017
Study Completion
March 1, 2018
Last Updated
May 22, 2018
Record last verified: 2018-05