Kyphoplasty With Structured Titanium Spheres

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

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).

Study Overview

• Status: Unknown
• Conditions: Vertebral Fracture
• Intervention / Treatment: Device: Kyphoplasty with insertion of Sctructured Titanium Microspheres; Device: Kyphoplasty with Polimethylmetacrilate (convetional surgery)

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 Type: Interventional
• Enrollment (Anticipated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gabriele Costantino; Phone Number: +39 3339088839; Email: gabriele.costantino@arnascivico.it

Study Locations

• Italy
  • PA
    • Palermo, PA, Italy, 90100
      • Recruiting
      • Gabriele Costantino
      • Contact: Gabriele Costantino; Phone Number: 00393339088839; Email: gabriele.costantino@arnascivico.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Kyphoplasty with Titanium spheres; Patients treated with kyphoplasty with baloons and insertion of titanium microspheres inside the body vertebra.	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.
Active Comparator: Kyphoplasty with Polymethylmethacrilate; Patients treated with Kyphoplasty with baloons and insertion of Polymethylmetacrylate inside the body vertebra.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: ARNAS Civico Di Cristina Benfratelli Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2019
• Primary Completion (Anticipated): September 25, 2020
• Study Completion (Anticipated): October 11, 2020

Study Registration Dates

• First Submitted: July 6, 2019
• First Submitted That Met QC Criteria: November 16, 2019
• First Posted (Actual): November 20, 2019

Study Record Updates

• Last Update Posted (Actual): November 20, 2019
• Last Update Submitted That Met QC Criteria: November 16, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Keywords: Titanium; EBM; Kyphoplasty; Microsphere; Vertebral fracture
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Spinal Injuries; Back Injuries; Spinal Fractures
• Other Study ID Numbers: 232 Civico 2018; MTOrtho (Other Identifier: MTOrtho)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No