Kyphoplasty With Structured Titanium Spheres
Primary Purpose
Vertebral Fracture
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Kyphoplasty with insertion of Sctructured Titanium Microspheres
Kyphoplasty with Polimethylmetacrilate (convetional surgery)
Sponsored by
About this trial
This is an interventional device feasibility trial for Vertebral Fracture focused on measuring Kyphoplasty, EBM, Titanium, Microsphere, Vertebral fracture
Eligibility Criteria
Inclusion Criteria:
- Magerl Type A Thoracolumbar fracture with no neurological deficits
- Age>18yy and < 80yy
- No ligament lesions
Exclusion Criteria:
- age < 18yy or > 80yy
- Ligament lesions
- refusal to sign informed consent
Sites / Locations
- Gabriele CostantinoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Kyphoplasty with Titanium spheres
Kyphoplasty with Polymethylmethacrilate
Arm Description
Patients treated with kyphoplasty with baloons and insertion of titanium microspheres inside the body vertebra.
Patients treated with Kyphoplasty with baloons and insertion of Polymethylmetacrylate inside the body vertebra.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Acquired kyphosis
Cobb angle measurement. No angle acquisition it will be considered as a good point.
Ostheogenesis
Induced osteogenesis investigated by Bone Scintigraphy. Osteoinduction will be considered as positive point.
Full Information
NCT ID
NCT04169659
First Posted
July 6, 2019
Last Updated
November 16, 2019
Sponsor
ARNAS Civico Di Cristina Benfratelli Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04169659
Brief Title
Kyphoplasty With Structured Titanium Spheres
Official Title
Kyphoplasty With Structured Titanium Spheres: Pilot Study. P.R.O.B.E. Trial (Prospective Randomized Open Blinded End Point)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
February 10, 2019 (Actual)
Primary Completion Date
September 25, 2020 (Anticipated)
Study Completion Date
October 11, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
ARNAS Civico Di Cristina Benfratelli Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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).
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vertebral Fracture
Keywords
Kyphoplasty, EBM, Titanium, Microsphere, Vertebral fracture
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective Rondomized Open Blinded End Point
Masking
Participant
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Kyphoplasty with Titanium spheres
Arm Type
Experimental
Arm Description
Patients treated with kyphoplasty with baloons and insertion of titanium microspheres inside the body vertebra.
Arm Title
Kyphoplasty with Polymethylmethacrilate
Arm Type
Active Comparator
Arm Description
Patients treated with Kyphoplasty with baloons and insertion of Polymethylmetacrylate inside the body vertebra.
Intervention Type
Device
Intervention Name(s)
Kyphoplasty with insertion of Sctructured Titanium Microspheres
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Kyphoplasty with Polimethylmetacrilate (convetional surgery)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility of prototype device usage, as assessed by Change from baseline in post-surgical complication rate at 1 month.
Description
Demonstrate if the prototype device is useful.
Time Frame
1 month post operative control
Secondary Outcome Measure Information:
Title
Visual analogical Scale (VAS) and changing in time.
Description
Visual analogical Scale (VAS) from 0 to 10. Decreasing of VAS, compared to base line, will be considered a good point.
Time Frame
immediate, follow-up at 1-3-6 months after trauma
Title
Pre, Post operation Vertebra height and changing in time
Description
Comparing Vertebra height in cm before and after surgery. Good height restoration will be considered a good point.
Time Frame
immediate, follow-up at 1-3-6 months after trauma
Title
Acquired kyphosis
Description
Cobb angle measurement. No angle acquisition it will be considered as a good point.
Time Frame
6 months after trauma
Title
Ostheogenesis
Description
Induced osteogenesis investigated by Bone Scintigraphy. Osteoinduction will be considered as positive point.
Time Frame
6 months after trauma
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Magerl Type A Thoracolumbar fracture with no neurological deficits
Age>18yy and < 80yy
No ligament lesions
Exclusion Criteria:
age < 18yy or > 80yy
Ligament lesions
refusal to sign informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriele Costantino
Phone
3339088839
Ext
+39
Email
gabriele.costantino@arnascivico.it
Facility Information:
Facility Name
Gabriele Costantino
City
Palermo
State/Province
PA
ZIP/Postal Code
90100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriele Costantino
Phone
00393339088839
Email
gabriele.costantino@arnascivico.it
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Kyphoplasty With Structured Titanium Spheres
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