Efficacy of Kyphoplasty With a New Intervertebral Expander
May 19, 2018 updated by: Mohammad ARAB MOTLAGH
Efficacy of Kyphoplasty With an Intravertebral Expander for Correction of Spine Deformity After Osteoporotic Vertebral Fracture
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
41
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Kyphoplasty
Patients underwent kyphoplasty with an intravertebral expander
|
Fractured vertebral body was reduced with an intravertebral expander and was cement augmented thereafter
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Radiological evaluation
Time Frame: 12 months
|
Kyphosis angle in degree and vertebral body height in cm are measured on lateral x-ray
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Visual Analogue Scale
Time Frame: 12 months
|
Scores range from 0 (no pain) to 10 (worst possible pain)
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mohammad Arab Motlagh, MD, PhD, Goethe University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2014
Primary Completion (Actual)
October 1, 2017
Study Completion (Actual)
March 1, 2018
Study Registration Dates
First Submitted
April 30, 2018
First Submitted That Met QC Criteria
April 30, 2018
First Posted (Actual)
May 11, 2018
Study Record Updates
Last Update Posted (Actual)
May 22, 2018
Last Update Submitted That Met QC Criteria
May 19, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- Kyphoplasty
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.