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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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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.

Mohammad Taghyan, MD contact

01006876892

mtoghyan@hotmail.com

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.

  1. 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.
  2. 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.

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 groups in NCT03682328
Study groupRoleWhat they receive
vertebroplastyActive comparatorPatients 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
kyphoplastyActive comparatorPatients 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.

  1. back pain

    Measuring and comparing the post-operative back pain via Visual analogue scales system

    Measured: up to 6 months

Secondary outcomes (1)
  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.

  1. First posted24 Sep 2018
  2. Study start1 Oct 2018 (estimated)
  3. Primary completion1 Aug 2020 (estimated)
  4. Study completion1 Sep 2020 (estimated)

Resources

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)
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 16291128
  • Phillips 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

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.

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