Kyphoplasty With Structured Titanium Spheres

Vertebral Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04169659
• Other study ID #: 232 Civico 2018
• Secondary ID: MTOrtho
• Status: Recruiting
• Phase: N/A
• Start date: February 10, 2019
• Est. completion date: October 11, 2020

Study information

• Verified date: November 2019
• Source: ARNAS Civico Di Cristina Benfratelli Hospital
• Contact: Gabriele Costantino
• Phone: 3339088839
• Email: gabriele.costantino[@]arnascivico.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: October 11, 2020
• Est. primary completion date: September 25, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Spinal Fractures
• Vertebral Fracture

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Gabriele Costantino	Palermo	PA

Sponsors (1)

Lead Sponsor	Collaborator
ARNAS Civico Di Cristina Benfratelli Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Acquired kyphosis	Cobb angle measurement. No angle acquisition it will be considered as a good point.	6 months after trauma
Secondary	Ostheogenesis	Induced osteogenesis investigated by Bone Scintigraphy. Osteoinduction will be considered as positive point.	6 months after trauma