Kyphoplasty With Structured Titanium Spheres
2 other identifiers
interventional
10
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 10, 2019
CompletedFirst Submitted
Initial submission to the registry
July 6, 2019
CompletedFirst Posted
Study publicly available on registry
November 20, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 25, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 11, 2020
CompletedNovember 20, 2019
November 1, 2019
1.6 years
July 6, 2019
November 16, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Visual analogical Scale (VAS) and changing in time.
immediate, follow-up at 1-3-6 months after trauma
Pre, Post operation Vertebra height and changing in time
immediate, follow-up at 1-3-6 months after trauma
Acquired kyphosis
6 months after trauma
Ostheogenesis
6 months after trauma
Study Arms (2)
Kyphoplasty with Titanium spheres
EXPERIMENTALPatients treated with kyphoplasty with baloons and insertion of titanium microspheres inside the body vertebra.
Kyphoplasty with Polymethylmethacrilate
ACTIVE COMPARATORPatients treated with Kyphoplasty with baloons and insertion of Polymethylmetacrylate inside the body vertebra.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Magerl Type A Thoracolumbar fracture with no neurological deficits
- Age\>18yy and \< 80yy
- No ligament lesions
You may not qualify if:
- age \< 18yy or \> 80yy
- Ligament lesions
- refusal to sign informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gabriele Costantino
Palermo, PA, 90100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 6, 2019
First Posted
November 20, 2019
Study Start
February 10, 2019
Primary Completion
September 25, 2020
Study Completion
October 11, 2020
Last Updated
November 20, 2019
Record last verified: 2019-11