Kyphoplasty With Structured Titanium Spheres

Not Applicable

• Conditions: Vertebral Fracture
• Interventions: Device: Kyphoplasty with insertion of Sctructured Titanium Microspheres; Device: Kyphoplasty with Polimethylmetacrilate (convetional surgery)

• Registration Number: NCT04169659
• Lead Sponsor: ARNAS Civico Di Cristina Benfratelli Hospital

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).

Study Timeline

• Study Start: 2019-02-10
• Study First Submitted: 2019-07-06
• Status Verified: 2019-11
• Study First Submitted QC: 2019-11-16
• Last Update Submitted: 2019-11-16
• Study First Posted: 2019-11-20
• Last Update Posted: 2019-11-20
• Primary Completion: 2020-09-25
• Study Completion: 2020-10-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Kyphoplasty with Titanium spheres	Kyphoplasty with insertion of Sctructured Titanium Microspheres	Patients treated with kyphoplasty with baloons and insertion of titanium microspheres inside the body vertebra.
Kyphoplasty with Polymethylmethacrilate	Kyphoplasty with Polimethylmetacrilate (convetional surgery)	Patients treated with Kyphoplasty with baloons and insertion of Polymethylmetacrylate inside the body vertebra.

Primary Outcome Measures

Name	Time	Method
Feasibility of prototype device usage, as assessed by Change from baseline in post-surgical complication rate at 1 month.	1 month post operative control	Demonstrate if the prototype device is useful.

Secondary Outcome Measures

Name	Time	Method
Pre, Post operation Vertebra height and changing in time	immediate, follow-up at 1-3-6 months after trauma	Comparing Vertebra height in cm before and after surgery. Good height restoration will be considered a good point.
Ostheogenesis	6 months after trauma	Induced osteogenesis investigated by Bone Scintigraphy. Osteoinduction will be considered as positive point.
Acquired kyphosis	6 months after trauma	Cobb angle measurement. No angle acquisition it will be considered as a good point.
Visual analogical Scale (VAS) and changing in time.	immediate, follow-up at 1-3-6 months after trauma	Visual analogical Scale (VAS) from 0 to 10. Decreasing of VAS, compared to base line, will be considered a good point.

Trial Locations

Locations (1)

Gabriele Costantino; 🇮🇹 Palermo, PA, Italy