Vertebral Body FractureNCT02557113
Creation of a Small Cavity Reduces the Rate of Cement Leakage During Vertebral Body Augmentation
A study testing Vertebroplasty and Cavuplasty in people with Vertebral Body Fracture, run by Mohammad ARAB MOTLAGH.
Trial summary
Leakage of polymethylmethacrylate (PMMA) is the most common complication during vertebral body augmentation and can lead to serious patient morbidity. Any measure to reduce the rate of cement leakage is of value and makes the procedure safer.The aim of this study was to investigate the effect of the creation of a… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vertebral Body Fracture
- What is being tested?
- Vertebroplasty and Cavuplasty
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jan 2013
- Phase
- Interventional
- 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
Who may be able to join
- Osteoporotic vertebral body fractures of the thoracolumbar spine (T9 to L4) 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: Creation of a Small Cavity in Vertebral Body Reduces the Rate of Cement Leakage During Vertebral Body Augmentation: A Prospective Randomized Controlled Study
Leakage of polymethylmethacrylate (PMMA) is the most common complication during vertebral body augmentation and can lead to serious patient morbidity. Any measure to reduce the rate of cement leakage is of value and makes the procedure safer.The aim of this study was to investigate the effect of the creation of a cavity on cement leakage during vertebroplasty. Investigators tested the hypothesis that the creation of a merely small and irregular cavity in vertebral body prior to cement injection would reduce cement leakage.
- Conditions
- Vertebral Body Fracture
- Being tested
- Vertebroplasty, Cavuplasty
- Keywords
- cement leakage, cement augmentation, vertebral body fracture, vertebral cavity, vertebroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VertebroplastyProcedure or surgery
Fractured Osteoporotic Vertebral Body is Augmented with Injection of Bone Cement
CavuplastyProcedure or surgery
Small Cavity is Created in Fractured Osteoporotic Vertebral Body Prior to Cement Injection
| Study group | Role | What they receive |
|---|---|---|
| Vertebroplasty | Active comparator | This Group Underwent the Vertebroplasty Procedure (Injection of Bone Cement into the Fractured Osteoporotic Vertebral Body) Receives: Procedure: Vertebroplasty |
| Cavuplasty | Experimental | This Group Underwent the Cavuplasty Procedure (Small Cavity was Created in the Vertebral Body Prior to Injection of Bone Cement) Receives: Procedure: Cavuplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
CT-Scan evaluation
Number of Cement Extravasation in each Vertebral Body
Measured: One week
Secondary outcomes (1)
Visual Analogue Scale
Scores range from 0 (no pain) to 10 (worst possible pain)
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startJan 2011
- Primary completionSep 2012
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral Body FractureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 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, Study director, Department of Orthopaedic Surgery University Hospital Frankfurt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557113
- Sponsor's protocol ID
- Cavuplasty
- Status last verified
- Sep 2015
- First submitted
- 20 Sep 2015
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creation of a Small Cavity in Vertebral Body Reduces the Rate of Cement Leakage During Vertebral Body Augmentation: A Prospective Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02557113
- Acronym / sponsor ID
- Cavuplasty
- Conditions
- Vertebral Body Fracture
- Keywords
- cement leakage, cement augmentation, vertebral body fracture, vertebral cavity, vertebroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mohammad ARAB MOTLAGHUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2012 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 23 Sep 2015 (estimated)
- 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.
Leakage of polymethylmethacrylate (PMMA) is the most common complication during vertebral body augmentation and can lead to serious patient morbidity. Any measure to reduce the rate of cement leakage is of value and makes the procedure safer.The aim of this study was to investigate the effect of the creation of a cavity on cement leakage during vertebroplasty. Investigators tested the hypothesis that the creation of a merely small and irregular cavity in vertebral body prior to cement injection would reduce cement leakage.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vertebroplasty | Active comparator | Procedure: VertebroplastyThis Group Underwent the Vertebroplasty Procedure (Injection of Bone Cement into the Fractured Osteoporotic Vertebral Body) |
| Cavuplasty | Experimental | Procedure: CavuplastyThis Group Underwent the Cavuplasty Procedure (Small Cavity was Created in the Vertebral Body Prior to Injection of Bone Cement) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Osteoporotic vertebral body fractures of the thoracolumbar spine (T9 to L4) 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 |
|---|---|---|
| VertebroplastyFractured Osteoporotic Vertebral Body is Augmented with Injection of Bone Cement | Procedure or surgery | Vertebroplasty |
| CavuplastySmall Cavity is Created in Fractured Osteoporotic Vertebral Body Prior to Cement Injection | Procedure or surgery | Cavuplasty |
Primary outcome
CT-Scan evaluation
Time frame: One week
Number of Cement Extravasation in each Vertebral Body
1 secondary outcome
Visual Analogue Scale
Time frame: 3 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 23 Sep 2015.
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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 study director
Department of Orthopaedic Surgery University Hospital Frankfurt
Questions about this trial
What is this clinical trial studying?
A study testing Vertebroplasty and Cavuplasty in people with Vertebral Body Fracture, 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 23 Sep 2015. 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?
CT-Scan evaluation (time frame: One week). 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 23 Sep 2015.