Vertebral Body CompressionNCT03521661
Efficacy of Kyphoplasty With a New Intervertebral Expander
An observational study of Vertebral Body Compression, run by Mohammad ARAB MOTLAGH.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertebral Body Compression
- What is being tested?
- Kyphoplasty
- Type of treatment
- Surgery or procedure
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 1 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Osteoporotic vertebral body fractures that were classified as A1 fractures according to Arbeitsgemeinschaft Osteosynthesis (AO) Classification
Who cannot join
- More than 2 vertebral body fractures
- Fractures of vertebral body based on malignancy
- Previous spinal operation
- Spinal infection
- Spinal deformity (scoliosis)
About this study
Official title: 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.
- Conditions
- Vertebral Body Compression
- Being tested
- Kyphoplasty
- Keywords
- Vertebral fracture, Kyphotic deformity, Kyphoplasty, Vertebroplasty
- Medical subject headings
- Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KyphoplastyProcedure or surgery
Fractured vertebral body was reduced with an intravertebral expander and was cement augmented thereafter
| Study group | Role | What they receive |
|---|---|---|
| Kyphoplasty | Patients underwent kyphoplasty with an intravertebral expander Receives: Procedure: Kyphoplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological evaluation
Kyphosis angle in degree and vertebral body height in cm are measured on lateral x-ray
Measured: 12 months
Secondary outcomes (1)
Visual Analogue Scale
Scores range from 0 (no pain) to 10 (worst possible pain)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start1 Jan 2014
- Primary completion1 Oct 2017
- Study completion1 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral Body CompressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohammad ARAB MOTLAGH
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohammad ARAB MOTLAGH, Johann Wolfgang Goethe University Hospital
- Investigators
- Mohammad Arab Motlagh, MD, PhD, Principal investigator, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521661
- Sponsor's protocol ID
- Kyphoplasty
- Status last verified
- May 2018
- First submitted
- 30 Apr 2018
- Last updated
- 22 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Kyphoplasty With an Intravertebral Expander for Correction of Spine Deformity After Osteoporotic Vertebral Fracture
- ClinicalTrials.gov ID
- NCT03521661
- Acronym / sponsor ID
- Kyphoplasty
- Conditions
- Vertebral Body Compression
- Keywords
- Vertebral fracture, Kyphotic deformity, Kyphoplasty, Vertebroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Mohammad ARAB MOTLAGHUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Mar 2018 (actual)
- First posted
- 11 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Kyphoplasty | – | Procedure: KyphoplastyPatients underwent kyphoplasty with an intravertebral expander |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Osteoporotic vertebral body fractures that were classified as A1 fractures according to Arbeitsgemeinschaft Osteosynthesis (AO) Classification
Key exclusion criteria (5 listed)
- More than 2 vertebral body fractures
- Fractures of vertebral body based on malignancy
- Previous spinal operation
- Spinal infection
- Spinal deformity (scoliosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KyphoplastyFractured vertebral body was reduced with an intravertebral expander and was cement augmented thereafter | Procedure or surgery | Kyphoplasty |
Primary outcome
Radiological evaluation
Time frame: 12 months
Kyphosis angle in degree and vertebral body height in cm are measured on lateral x-ray
1 secondary outcome
Visual Analogue Scale
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2018.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Arab Motlagh, MD, PhD principal investigator
Goethe University
Questions about this trial
What is this clinical trial studying?
An observational study of Vertebral Body Compression, run by Mohammad ARAB MOTLAGH.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiological evaluation (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2018; AzTrials last refreshed its copy on 7 Nov 2026.