Clinical trial NCT04169659: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Vertebral Fracture
Keywords: Kyphoplasty
EBM
Titanium
Microsphere
Vertebral fracture
Lead sponsor: ARNAS Civico Di Cristina Benfratelli Hospital
Sponsor class: OTHER
First posted: 2019-11-20
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective Rondomized Open Blinded End Point
Primary purpose: DEVICE_FEASIBILITY

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).

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

Primary outcomes:
measure: Feasibility of prototype device usage, as assessed by Change from baseline in post-surgical complication rate at 1 month.
timeFrame: 1 month post operative control
Secondary outcomes:
measure: Visual analogical Scale (VAS) and changing in time.
timeFrame: immediate, follow-up at 1-3-6 months after trauma
measure: Pre, Post operation Vertebra height and changing in time
timeFrame: immediate, follow-up at 1-3-6 months after trauma
measure: Acquired kyphosis
timeFrame: 6 months after trauma
measure: Ostheogenesis
timeFrame: 6 months after trauma
Other outcomes:
Locations:
city: Palermo
country: Italy
facility: Gabriele Costantino
state: PA
Study officials:
References: