Ignite Creation Date:
2025-12-24 @ 2:29 PM
Ignite Modification Date:
2026-01-04 @ 8:55 AM
Study NCT ID:
NCT04169659
Status:
UNKNOWN
Last Update Posted:
2019-11-20
First Post:
2019-07-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Kyphoplasty With Structured Titanium Spheres
Sponsor:
ARNAS Civico Di Cristina Benfratelli Hospital
Organization:
Study Overview
Official Title:
Kyphoplasty With Structured Titanium Spheres: Pilot Study. P.R.O.B.E. Trial (Prospective Randomized Open Blinded End Point)
Status:
UNKNOWN
Status Verified Date:
2019-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| MTOrtho | OTHER | MTOrtho | View |