Kyphoplasty With Structured Titanium Spheres

NCT ID: NCT04169659

Last Updated: 2019-11-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-02-10
• Study Completion Date: 2020-10-11

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).

Conditions

Vertebral Fracture

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: SINGLE

Study Groups

Kyphoplasty with Titanium spheres

Patients treated with kyphoplasty with baloons and insertion of titanium microspheres inside the body vertebra.

Group Type: EXPERIMENTAL

Kyphoplasty with insertion of Sctructured Titanium Microspheres

Intervention Type: DEVICE

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 Polymethylmethacrilate

Patients treated with Kyphoplasty with baloons and insertion of Polymethylmetacrylate inside the body vertebra.

Group Type: ACTIVE_COMPARATOR

Kyphoplasty with Polimethylmetacrilate (convetional surgery)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ARNAS Civico Di Cristina Benfratelli Hospital

OTHER

Sponsor Role: lead

Responsible Party

Gabriele Costantino

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gabriele Costantino

Palermo, PA, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Gabriele Costantino

Role: CONTACT

gabriele.costantino@arnascivico.it

3339088839 ext. +39

Facility Contacts

Gabriele Costantino

Role: primary

gabriele.costantino@arnascivico.it

00393339088839

Other Identifiers

MTOrtho

Identifier Type: OTHER

Identifier Source: secondary_id

232 Civico 2018

Identifier Type: -

Identifier Source: org_study_id