Kyphoplasty With Structured Titanium Spheres

ARNAS Civico Di Cristina Benfratelli Hospital

Status: Unknown

Conditions: Vertebral Fracture

Treatments: Device: Kyphoplasty with insertion of Sctructured Titanium Microspheres; Device: Kyphoplasty with Polimethylmetacrilate (convetional surgery)

Study type: Interventional

Funder types: Other

Identifiers

NCT04169659

MTOrtho (Other Identifier)

232 Civico 2018

Details and patient eligibility

About

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).

Full 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).

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 2 patient groups

Kyphoplasty with Titanium spheres

Experimental group

Description:

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

Treatment:

Device: Kyphoplasty with insertion of Sctructured Titanium Microspheres

Kyphoplasty with Polymethylmethacrilate

Active Comparator group

Description:

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

Treatment:

Device: Kyphoplasty with Polimethylmetacrilate (convetional surgery)