Vertebral FractureNCT04169659
Kyphoplasty With Structured Titanium Spheres
A study testing Kyphoplasty with insertion of Sctructured Titanium Microspheres and Kyphoplasty with Polimethylmetacrilate (convetional surgery) in people with Vertebral Fracture, run by ARNAS Civico Di Cristina Benfratelli Hospital at 1 site in Italy.
Trial summary
The aim of the trial is to study efficacy and safety of Kyphoplasty technique with porous titanium microspheres in patients with type A vertebral body fracture (according to Magerl classification). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Vertebral Fracture
- What is being tested?
- Kyphoplasty with insertion of Sctructured Titanium Microspheres and Kyphoplasty with Polimethylmetacrilate (convetional surgery)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 10 Feb 2019to 11 Oct 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Magerl Type A Thoracolumbar fracture with no neurological deficits
- Age>18yy and < 80yy
- No ligament lesions
Who cannot join
- age < 18yy or > 80yy
- Ligament lesions
- refusal to sign informed consent
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
Gabriele Costantino
Palermo, PA, 90100
Gabriele Costantino, 00393339088839, gabriele.costantino@arnascivico.it
About this study
Official title: Kyphoplasty With Structured Titanium Spheres: Pilot Study. P.R.O.B.E. Trial (Prospective Randomized Open Blinded End Point)
The aim of the trial is to study efficacy and safety of Kyphoplasty technique with porous titanium microspheres in patients with type A vertebral body fracture (according to Magerl classification).
Read the detailed description
Randomized controlled open trial with P.R.O.B.E. design (Prospective Randomized Open, Blinded End-point)
Objective:
The aim of the trial is to study efficacy and safety of Kyphoplasty technique with porous titanium microspheres in patients with type A vertebral body fracture (according to Magerl classification).
All consecutive eligible patients, belonging to the Neurosurgery Unit of A.R.N.A.S. Civico Hospital, in Palermo, will be included in the pilot study: 10 patients will be recruited for the treatment arm and 10 patients for the control arm.
- Patients aged between 18 and 80 years.
- Diagnosis of vertebral body fracture, type A (according to Magerl classification) in particular A.1, A.2 and A.3.1.
- Absence of ligamentous structures lesion and / or invasion of the spinal canal, confirmed by RX TC and NMR.
- Refusal to sign informed consent,
- Diagnosis different from those established by inclusion criteria.
- Age under 18 years.
- Age over 80 years.
- Presence of ligamentous structures lesion and / or invasion of the spinal canal confirmed by RX, TC and NMR.
For each patient will be evaluated:
- Spine RX
- CT of the spinal layer (or Spine CT)
- Spine MRI
- Roland Morris Disability (for the assessment of low back pain)
- EQ-5D (health questionnaire)
- Denis Work Scale (for the assessment of working conditions)
- VAS (for pain assessment)
- The statistical analysis will be performed using the SPSS software vers. 12.0 (SPSS Inc., Chicago, IL, United States). The study data will be collected pursuant to and for the purposes of articles 13 and 23 of the D. L.gs. n. 196/2003.
The study will be performed according to the rules established by the principles of Good Clinical Practice (as per Ministerial Decree of 07/15/97) and according to the principles gathered in the Helsinki Declaration (52 nd WMA General Assembly version, Edimburgh, Scotland, October 2000 ).
The clinical practices are performed according to the most recent recommendations of the World Medical Assembly (Declaration of Helsinki, 1964, and subsequent amendments).
- Conditions
- Vertebral Fracture
- Being tested
- Kyphoplasty with insertion of Sctructured Titanium Microspheres, Kyphoplasty with Polimethylmetacrilate (convetional surgery)
- Keywords
- Kyphoplasty, EBM, Titanium, Microsphere, Vertebral fracture
- Medical subject headings
- Spinal Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kyphoplasty with insertion of Sctructured Titanium MicrospheresDevice
Under fluoroscophy, we introduce a transpeduncolar trocar inside the vertebral body where is performed a kyphoplasty with insertion of baloons. When the dome is cretated we introduce structured titanium microspheres until the dome is full of material.
Kyphoplasty with Polimethylmetacrilate (convetional surgery)Device
Under fluoroscophy, we introduce a transpeduncolar trocar inside the vertebral body where is performed a kyphoplasty with insertion of baloons. When the dome is cretated we introduce Polimethylmetacrilate until the dome is full of material.
| Study group | Role | What they receive |
|---|---|---|
| Kyphoplasty with Titanium spheres | Experimental | Patients treated with kyphoplasty with baloons and insertion of titanium microspheres inside the body vertebra. Receives: Device: Kyphoplasty with insertion of Sctructured Titanium Microspheres |
| Kyphoplasty with Polymethylmethacrilate | Active comparator | Patients treated with Kyphoplasty with baloons and insertion of Polymethylmetacrylate inside the body vertebra. Receives: Device: Kyphoplasty with Polimethylmetacrilate (convetional surgery) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of prototype device usage, as assessed by Change from baseline in post-surgical complication rate at 1 month.
Demonstrate if the prototype device is useful.
Measured: 1 month post operative control
Secondary outcomes (4)
Visual analogical Scale (VAS) and changing in time.
Visual analogical Scale (VAS) from 0 to 10. Decreasing of VAS, compared to base line, will be considered a good point.
Measured: immediate, follow-up at 1-3-6 months after trauma
Pre, Post operation Vertebra height and changing in time
Comparing Vertebra height in cm before and after surgery. Good height restoration will be considered a good point.
Measured: immediate, follow-up at 1-3-6 months after trauma
Acquired kyphosis
Cobb angle measurement. No angle acquisition it will be considered as a good point.
Measured: 6 months after trauma
Ostheogenesis
Induced osteogenesis investigated by Bone Scintigraphy. Osteoinduction will be considered as positive point.
Measured: 6 months after trauma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2019
- Study start10 Feb 2019
- Primary completion25 Sep 2020 (estimated)
- Study completion11 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebral 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Rondomized Open Blinded End Point
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ARNAS Civico Di Cristina Benfratelli Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Costantino, ARNAS Civico Di Cristina Benfratelli Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169659
- Sponsor's protocol ID
- 232 Civico 2018
- Other IDs
- MTOrtho
- Status last verified
- Nov 2019
- First submitted
- 6 Jul 2019
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kyphoplasty With Structured Titanium Spheres: Pilot Study. P.R.O.B.E. Trial (Prospective Randomized Open Blinded End Point)
- ClinicalTrials.gov ID
- NCT04169659
- Acronym / sponsor ID
- 232 Civico 2018
- Conditions
- Vertebral Fracture
- Keywords
- Kyphoplasty, EBM, Titanium, Microsphere, Vertebral fracture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- ARNAS Civico Di Cristina Benfratelli HospitalUniversity, hospital or other
- Study start
- 10 Feb 2019 (actual)
- Primary completion
- 25 Sep 2020 (estimated)
- Study completion
- 11 Oct 2020 (estimated)
- First posted
- 20 Nov 2019 (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.
The aim of the trial is to study efficacy and safety of Kyphoplasty technique with porous titanium microspheres in patients with type A vertebral body fracture (according to Magerl classification).
Detailed description
Randomized controlled open trial with P.R.O.B.E. design (Prospective Randomized Open, Blinded End-point)
Objective:
The aim of the trial is to study efficacy and safety of Kyphoplasty technique with porous titanium microspheres in patients with type A vertebral body fracture (according to Magerl classification).
All consecutive eligible patients, belonging to the Neurosurgery Unit of A.R.N.A.S. Civico Hospital, in Palermo, will be included in the pilot study: 10 patients will be recruited for the treatment arm and 10 patients for the control arm.
- Patients aged between 18 and 80 years.
- Diagnosis of vertebral body fracture, type A (according to Magerl classification) in particular A.1, A.2 and A.3.1.
- Absence of ligamentous structures lesion and / or invasion of the spinal canal, confirmed by RX TC and NMR.
- Refusal to sign informed consent,
- Diagnosis different from those established by inclusion criteria.
- Age under 18 years.
- Age over 80 years.
- Presence of ligamentous structures lesion and / or invasion of the spinal canal confirmed by RX, TC and NMR.
For each patient will be evaluated:
- Spine RX
- CT of the spinal layer (or Spine CT)
- Spine MRI
- Roland Morris Disability (for the assessment of low back pain)
- EQ-5D (health questionnaire)
- Denis Work Scale (for the assessment of working conditions)
- VAS (for pain assessment)
- The statistical analysis will be performed using the SPSS software vers. 12.0 (SPSS Inc., Chicago, IL, United States). The study data will be collected pursuant to and for the purposes of articles 13 and 23 of the D. L.gs. n. 196/2003.
The study will be performed according to the rules established by the principles of Good Clinical Practice (as per Ministerial Decree of 07/15/97) and according to the principles gathered in the Helsinki Declaration (52 nd WMA General Assembly version, Edimburgh, Scotland, October 2000 ).
The clinical practices are performed according to the most recent recommendations of the World Medical Assembly (Declaration of Helsinki, 1964, and subsequent amendments).
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective Rondomized Open Blinded End Point
| Arm | Type | Receives |
|---|---|---|
| Kyphoplasty with Titanium spheres | Experimental | Device: Kyphoplasty with insertion of Sctructured Titanium MicrospheresPatients treated with kyphoplasty with baloons and insertion of titanium microspheres inside the body vertebra. |
| Kyphoplasty with Polymethylmethacrilate | Active comparator | Device: Kyphoplasty with Polimethylmetacrilate (convetional surgery)Patients treated with Kyphoplasty with baloons and insertion of Polymethylmetacrylate inside the body vertebra. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Magerl Type A Thoracolumbar fracture with no neurological deficits
- Age>18yy and < 80yy
- No ligament lesions
Key exclusion criteria (3 listed)
- age < 18yy or > 80yy
- Ligament lesions
- refusal to sign informed consent
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 |
|---|---|---|
| Kyphoplasty with insertion of Sctructured Titanium MicrospheresUnder fluoroscophy, we introduce a transpeduncolar trocar inside the vertebral body where is performed a kyphoplasty with insertion of baloons. When the dome is cretated we introduce structured titanium microspheres until the dome is full of material. | Device | Kyphoplasty with Titanium spheres |
| Kyphoplasty with Polimethylmetacrilate (convetional surgery)Under fluoroscophy, we introduce a transpeduncolar trocar inside the vertebral body where is performed a kyphoplasty with insertion of baloons. When the dome is cretated we introduce Polimethylmetacrilate until the dome is full of material. | Device | Kyphoplasty with Polymethylmethacrilate |
Primary outcome
Feasibility of prototype device usage, as assessed by Change from baseline in post-surgical complication rate at 1 month.
Time frame: 1 month post operative control
Demonstrate if the prototype device is useful.
4 secondary outcomes
Visual analogical Scale (VAS) and changing in time.
Time frame: immediate, follow-up at 1-3-6 months after trauma
Pre, Post operation Vertebra height and changing in time
Time frame: immediate, follow-up at 1-3-6 months after trauma
Acquired kyphosis
Time frame: 6 months after trauma
Ostheogenesis
Time frame: 6 months after trauma
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kyphoplasty with insertion of Sctructured Titanium Microspheres and Kyphoplasty with Polimethylmetacrilate (convetional surgery) in people with Vertebral Fracture, run by ARNAS Civico Di Cristina Benfratelli Hospital at 1 site in Italy.
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 3 inclusion and 3 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 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Gabriele Costantino (3339088839 ext. +39, gabriele.costantino@arnascivico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of prototype device usage, as assessed by Change from baseline in post-surgical complication rate at 1 month. (time frame: 1 month post operative control). 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 20 Nov 2019.