NCT04169659

Kyphoplasty With Structured Titanium Spheres

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: ARNAS Civico Di Cristina Benfratelli Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Vertebral Fracture

Interventions

Type	Name	Description
DEVICE	Kyphoplasty 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.
DEVICE	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.

Timeline

• Start date: 2019-02-10
• Primary completion: 2020-09-25
• Completion: 2020-10-11
• First posted: 2019-11-20
• Last updated: 2019-11-20

Locations

1 site across 1 country: Italy