Kyphoplasty With Structured Titanium Spheres

Study Overview
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Brief Summary
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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
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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).

Official Title
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Kyphoplasty With Structured Titanium Spheres: Pilot Study. P.R.O.B.E. Trial (Prospective Randomized Open Blinded End Point)

Conditions
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Vertebral Fracture

Intervention / Treatment
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* Device: Kyphoplasty with insertion of Sctructured Titanium Microspheres
* Device: Kyphoplasty with Polimethylmetacrilate (convetional surgery)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective Rondomized Open Blinded End Point
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kyphoplasty with Titanium spheres<br>Patients treated with kyphoplasty with baloons and insertion of titanium microspheres inside the body vertebra. | Device: Kyphoplasty with insertion of Sctructured Titanium Microspheres<br>* 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.<br>|
| Active Comparator: Kyphoplasty with Polymethylmethacrilate<br>Patients treated with Kyphoplasty with baloons and insertion of Polymethylmetacrylate inside the body vertebra. | Device: Kyphoplasty with Polimethylmetacrilate (convetional surgery)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 month post operative control | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 6 months after trauma | 
| Ostheogenesis | Induced osteogenesis investigated by Bone Scintigraphy. Osteoinduction will be considered as positive point. | 6 months after trauma | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Kyphoplasty, EBM, Titanium, Microsphere, Vertebral fracture