Vertebral Fracture
Conditions
Keywords
Kyphoplasty, EBM, Titanium, Microsphere, Vertebral fracture
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).
Interventions
DEVICEKyphoplasty with insertion of Sctructured Titanium Microspheres
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.
DEVICEKyphoplasty 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.
Sponsors
ARNAS Civico Di Cristina Benfratelli Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Subject)
Intervention model description
Prospective Rondomized Open Blinded End Point
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of prototype device usage, as assessed by Change from baseline in post-surgical complication rate at 1 month. | 1 month post operative control | Demonstrate if the prototype device is useful. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogical Scale (VAS) and changing in time. | immediate, follow-up at 1-3-6 months after trauma | 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 | immediate, follow-up at 1-3-6 months after trauma | Comparing Vertebra height in cm before and after surgery. Good height restoration will be considered a good point. |
| Acquired kyphosis | 6 months after trauma | Cobb angle measurement. No angle acquisition it will be considered as a good point. |
| Ostheogenesis | 6 months after trauma | Induced osteogenesis investigated by Bone Scintigraphy. Osteoinduction will be considered as positive point. |
Countries
Italy
Contacts
Primary ContactGabriele Costantino
Outcome results
None listed