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Kyphoplasty With Structured Titanium Spheres

NCT04169659 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2019-11-20

No results posted yet for this study

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).

Conditions

  • Vertebral Fracture

Interventions

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.

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.

Sponsors & Collaborators

  • ARNAS Civico Di Cristina Benfratelli Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-10
Primary Completion
2020-09-25
Completion
2020-10-11

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04169659 on ClinicalTrials.gov