Osteoporotic Fracture of VertebraNCT03682328
Vertebroplasty and Kyphoplasty in Osteoporotic Vertebral Body Fractures.
A study testing vertebroplasty and kyphoplaty in people with Osteoporotic Fracture of Vertebra, run by Assiut University.
Trial summary
Vertebral body fractures are a major health care problem in all countries with incidence 1.4%. They are a common cause of severe debilitating pain, with consequent deteriorated quality of life, physical function and psychosocial performance. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Osteoporotic Fracture of Vertebra
- What is being tested?
- vertebroplasty and kyphoplaty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2018to 1 Sep 2020
- 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 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: > 60 years.
- Sex: both males and females.
- Compressive and burst vertebral body fractures without any neurological deficit.
- Failure of medical treatment for at least 3-4 weeks
Who cannot join
- Unmanageable bleeding disorder.
- Improvement of the symptoms of the patient with conservative management.
- Asymptomatic vertebral body fracture or presence of neurological deficit.
- Local or generalized infection.
- Known allergy to bone cement.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparetive Study Between Vertebroplasty and Kyphoplasty in the Management of Osteoporotic Vertebral Body Fractures.
Vertebral body fractures are a major health care problem in all countries with incidence 1.4%. They are a common cause of severe debilitating pain, with consequent deteriorated quality of life, physical function and psychosocial performance.
Surgery is indicated in patients with vertebral body fracture, and concurrent spinal instability or neurologic deficit. The cornerstone of management for vertebral body fractures without neurological impairment is medical therapy, which include analgesics, bed rest, orthoses and rehabilitation. In the majority of patients such treatment modalities are effective. However, conservative management measures are not indicated for every type of fracture. For example, in older patients with vertebral fractures and cardio-respiratory disease it is not possible to prescribe bedrest for long period. Moreover, sometimes anti-inflammatory drugs are poorly tolerated by older patients, and bed rest can lead to further demineralization of the vertebrae, predisposing to future fractures.
Read more
Percutaneous minimally invasive vertebral augmentation methods for cement application into the vertebral body are a useful tool for the management of symptomatic fractures without neurological impairment when conventional measures of treatment can not be adopted. Two different percutaneous minimally invasive vertebral augmentation methods for cement application into the vertebral body for the management of symptomatic vertebral body fractures without neurological impairment have been developed, namely vertebroplasty and kyphoplasty.
Kyphoplasty and vertebroplasty have gained wide acceptance worldwide to manage patients without neurological impairment suffering from unmanageable pain caused by vertebral body fractures. Both procedures depend on mechanical stabilization of the fracture produced by cement injection into the fractured vertebral body.
Cement augmentation of the vertebral body by vertebroplasty and kyphoplasty was originally introduced for osteoporotic compression fractures, but surgeons have now applied these techniques as a method of enhancing anterior column support while avoiding the morbidity and complications associated with anterior approaches.
The mainstay of the controversy between kyphoplasty and vertebroplasty are height restoration, whether or not this height restoration is clinically significant, and the risks related to height restoration.
Read the detailed description
This study is a Randomized interventional study to be done at neurosurgery department, Assiut Universitu Hospital, Assiut university, Egypt.
- Vertebroplasty To achieve a low complication rate, the most important factor which influences the result of the vertebroplasty is the visualization of needle placement and cement application. Vertebroplasty may be performed using both fluoroscopy, and CT scanning to obtain an accurate visualization of needle position and cement distribution. The monitoring of the distribution of the cement under direct fluoroscopic control is another crucial aspect of the procedure, independently from the technique used for needle placement. Vertebroplasty can be performed under local anaesthesia or a combination of conscious sedation in most patients, and is therefore particularly useful in patients with risk factors for general anaesthesia. General anaesthesia is required only in patients unable to cooperate due to pain or in very agitated patients. The access path depends on the level of the vertebral segment to be injected. In the lumbar spine, a transpedicular route is preferred. In the thoracic vertebrae, an intercostovertebral access is recommended. In the cervical vertebrae, an anterolateral approach is used. The cement should be injected while in its tooth-paste like phase to minimize complications from extravasation in the surrounding tissues, as the flow characteristics of the cement change over the time. Cement injection may be stopped when the anterior two thirds of the vertebral body are filled and the cement is homogenously distributed between both endplates. During cement injection, continuous fluoroscopic monitoring is performed to immediately detect extravasations of cement. In case of extravasation, the procedure must be interrupted. A direct correlation between the risk of extraosseous extravasation and the amount of cement injection has been proposed, but, to date, no studies have addressed the specific issue of the volume of cement needed during vertebroplasty. Normally, 2.5-4 mL of cement should provide good filling of the vertebra and achieve both consolidation and pain relief in patients with osteoporotic fractures.
- Kyphoplasty Kyphoplasty is normally performed under general anaesthesia in some patients as proper placement of the balloons is mandatory, and several steps need to be taken before cement can be injected.
A mono- or bilateral trans- or para-pedicular approach is used to insert a working cannula into the posterior aspect of the vertebral body. The procedure is performed under fluoroscopy or CT scan control. With reaming tools, two working channels within the anterior aspect of the vertebral body are produced, and the appropriate balloon is inserted. To reduce the fractured vertebra and to produce a cavity, the balloon is inflated using visual volume and pressure controls. The behaviour of the vertebral body is monitored under fluoroscopic control. Inflation is stopped when a pressure above 250 psi is obtained, when the balloon contacts the cortical surface of the vertebral body, or if the balloon expands beyond the border of the vertebral body, and if the height of the vertebra is restored. Successively, the balloons are retracted and cement polymethylmetacrylate (PMMA) is injected using a blunt cannula under continuous fluoroscopic control.
- Conditions
- Osteoporotic Fracture of Vertebra
- Being tested
- vertebroplasty, kyphoplaty
- Keywords
- Vertebroplasty, Kyphoplasty, Osteoporosis, Vertebral fractures
- Medical subject headings
- Osteoporosis, Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vertebroplastyProcedure or surgery
Cement augmentation of the vertebral body
kyphoplatyProcedure or surgery
Cement augmentation of the vertebral body
| Study group | Role | What they receive |
|---|---|---|
| vertebroplasty | Active comparator | Patients will be managed by equipment of vertebroplasty (Osteofix from Tsunami Medical Made in Italy which is composed of a packet of PMMA and ampule of MMA). Receives: Procedure: vertebroplasty |
| kyphoplasty | Active comparator | Patients will be managed by equipment of kyphoplasty (Osteofix from Tsunami Medical Made in Italy which is composed of a packet of PMMA and ampule of MMA). Receives: Procedure: kyphoplaty |
What is being measured
The primary outcome is the main question the study is designed to answer.
back pain
Measuring and comparing the post-operative back pain via Visual analogue scales system
Measured: up to 6 months
Secondary outcomes (1)
kyphotic deformity
Measuring and comparing the post-operative via kyphotic deformity Cobb's angle.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2018
- Study start1 Oct 2018 (estimated)
- Primary completion1 Aug 2020 (estimated)
- Study completion1 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Osteoporotic Fracture of VertebraStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud M. Gamal, Assiut University
- Investigators
- Ahmed Abdalla, MD, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03682328
- Sponsor's protocol ID
- Vertebroplasty and kyphoplasty
- Status last verified
- Sep 2018
- First submitted
- 19 Sep 2018
- Last updated
- 24 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lieberman IH, Togawa D, Kayanja MM. Vertebroplasty and kyphoplasty: filler materials. Spine J. 2005 Nov-Dec;5(6 Suppl):305S-316S. doi: 10.1016/j.spinee.2005.02.020.
PubMed 16291128Phillips FM. Minimally invasive treatments of osteoporotic vertebral compression fractures. Spine (Phila Pa 1976). 2003 Aug 1;28(15 Suppl):S45-53. doi: 10.1097/01.BRS.0000076898.37566.32.
PubMed 12897474
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparetive Study Between Vertebroplasty and Kyphoplasty in the Management of Osteoporotic Vertebral Body Fractures.
- ClinicalTrials.gov ID
- NCT03682328
- Acronym / sponsor ID
- Vertebroplasty and kyphoplasty
- Conditions
- Osteoporotic Fracture of Vertebra
- Keywords
- Vertebroplasty, Kyphoplasty, Osteoporosis, Vertebral fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (estimated)
- Primary completion
- 1 Aug 2020 (estimated)
- Study completion
- 1 Sep 2020 (estimated)
- First posted
- 24 Sep 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.
Vertebral body fractures are a major health care problem in all countries with incidence 1.4%. They are a common cause of severe debilitating pain, with consequent deteriorated quality of life, physical function and psychosocial performance.
Surgery is indicated in patients with vertebral body fracture, and concurrent spinal instability or neurologic deficit. The cornerstone of management for vertebral body fractures without neurological impairment is medical therapy, which include analgesics, bed rest, orthoses and rehabilitation. In the majority of patients such treatment modalities are effective. However, conservative management measures are not indicated for every type of fracture. For example, in older patients with vertebral fractures and cardio-respiratory disease it is not possible to prescribe bedrest for long period. Moreover, sometimes anti-inflammatory drugs are poorly tolerated by older patients, and bed rest can lead to further demineralization of the vertebrae, predisposing to future fractures.
Percutaneous minimally invasive vertebral augmentation methods for cement application into the vertebral body are a useful tool for the management of symptomatic fractures without neurological impairment when conventional measures of treatment can not be adopted. Two different percutaneous minimally invasive vertebral augmentation methods for cement application into the vertebral body for the management of symptomatic vertebral body fractures without neurological impairment have been developed, namely vertebroplasty and kyphoplasty.
Kyphoplasty and vertebroplasty have gained wide acceptance worldwide to manage patients without neurological impairment suffering from unmanageable pain caused by vertebral body fractures. Both procedures depend on mechanical stabilization of the fracture produced by cement injection into the fractured vertebral body.
Cement augmentation of the vertebral body by vertebroplasty and kyphoplasty was originally introduced for osteoporotic compression fractures, but surgeons have now applied these techniques as a method of enhancing anterior column support while avoiding the morbidity and complications associated with anterior approaches.
The mainstay of the controversy between kyphoplasty and vertebroplasty are height restoration, whether or not this height restoration is clinically significant, and the risks related to height restoration.
Detailed description
This study is a Randomized interventional study to be done at neurosurgery department, Assiut Universitu Hospital, Assiut university, Egypt.
- Vertebroplasty To achieve a low complication rate, the most important factor which influences the result of the vertebroplasty is the visualization of needle placement and cement application. Vertebroplasty may be performed using both fluoroscopy, and CT scanning to obtain an accurate visualization of needle position and cement distribution. The monitoring of the distribution of the cement under direct fluoroscopic control is another crucial aspect of the procedure, independently from the technique used for needle placement. Vertebroplasty can be performed under local anaesthesia or a combination of conscious sedation in most patients, and is therefore particularly useful in patients with risk factors for general anaesthesia. General anaesthesia is required only in patients unable to cooperate due to pain or in very agitated patients. The access path depends on the level of the vertebral segment to be injected. In the lumbar spine, a transpedicular route is preferred. In the thoracic vertebrae, an intercostovertebral access is recommended. In the cervical vertebrae, an anterolateral approach is used. The cement should be injected while in its tooth-paste like phase to minimize complications from extravasation in the surrounding tissues, as the flow characteristics of the cement change over the time. Cement injection may be stopped when the anterior two thirds of the vertebral body are filled and the cement is homogenously distributed between both endplates. During cement injection, continuous fluoroscopic monitoring is performed to immediately detect extravasations of cement. In case of extravasation, the procedure must be interrupted. A direct correlation between the risk of extraosseous extravasation and the amount of cement injection has been proposed, but, to date, no studies have addressed the specific issue of the volume of cement needed during vertebroplasty. Normally, 2.5-4 mL of cement should provide good filling of the vertebra and achieve both consolidation and pain relief in patients with osteoporotic fractures.
- Kyphoplasty Kyphoplasty is normally performed under general anaesthesia in some patients as proper placement of the balloons is mandatory, and several steps need to be taken before cement can be injected.
A mono- or bilateral trans- or para-pedicular approach is used to insert a working cannula into the posterior aspect of the vertebral body. The procedure is performed under fluoroscopy or CT scan control. With reaming tools, two working channels within the anterior aspect of the vertebral body are produced, and the appropriate balloon is inserted. To reduce the fractured vertebra and to produce a cavity, the balloon is inflated using visual volume and pressure controls. The behaviour of the vertebral body is monitored under fluoroscopic control. Inflation is stopped when a pressure above 250 psi is obtained, when the balloon contacts the cortical surface of the vertebral body, or if the balloon expands beyond the border of the vertebral body, and if the height of the vertebra is restored. Successively, the balloons are retracted and cement polymethylmetacrylate (PMMA) is injected using a blunt cannula under continuous fluoroscopic control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| vertebroplasty | Active comparator | Procedure: vertebroplastyPatients will be managed by equipment of vertebroplasty (Osteofix from Tsunami Medical Made in Italy which is composed of a packet of PMMA and ampule of MMA). |
| kyphoplasty | Active comparator | Procedure: kyphoplatyPatients will be managed by equipment of kyphoplasty (Osteofix from Tsunami Medical Made in Italy which is composed of a packet of PMMA and ampule of MMA). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: > 60 years.
- Sex: both males and females.
- Compressive and burst vertebral body fractures without any neurological deficit.
- Failure of medical treatment for at least 3-4 weeks
Key exclusion criteria (5 listed)
- Unmanageable bleeding disorder.
- Improvement of the symptoms of the patient with conservative management.
- Asymptomatic vertebral body fracture or presence of neurological deficit.
- Local or generalized infection.
- Known allergy to bone cement.
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 |
|---|---|---|
| vertebroplastyCement augmentation of the vertebral body | Procedure or surgery | vertebroplasty |
| kyphoplatyCement augmentation of the vertebral body | Procedure or surgery | kyphoplasty |
Primary outcome
back pain
Time frame: up to 6 months
Measuring and comparing the post-operative back pain via Visual analogue scales system
1 secondary outcome
kyphotic deformity
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
- Background: PubMed 16291128Lieberman IH, Togawa D, Kayanja MM. Vertebroplasty and kyphoplasty: filler materials. Spine J. 2005 Nov-Dec;5(6 Suppl):305S-316S. doi: 10.1016/j.spinee.2005.02.020.
- Background: PubMed 12897474Phillips FM. Minimally invasive treatments of osteoporotic vertebral compression fractures. Spine (Phila Pa 1976). 2003 Aug 1;28(15 Suppl):S45-53. doi: 10.1097/01.BRS.0000076898.37566.32.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed Abdalla, MD study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing vertebroplasty and kyphoplaty in people with Osteoporotic Fracture of Vertebra, run by Assiut University.
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 4 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: status not confirmed, as of the sponsor's last update on 24 Sep 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Gamal, M.Sc (+201000630887, mahmoud_gamal20102000@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
back pain (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03682328, which also lists 2 linked publications.
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 24 Sep 2018.