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| ID | Type | Description | Link |
|---|---|---|---|
| MTOrtho | Other Identifier | MTOrtho |
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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).
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.
For each patient will be evaluated:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Kyphoplasty with Titanium spheres | Experimental | Patients treated with kyphoplasty with baloons and insertion of titanium microspheres inside the body vertebra. |
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| Kyphoplasty with Polymethylmethacrilate | Active Comparator | Patients treated with Kyphoplasty with baloons and insertion of Polymethylmetacrylate inside the body vertebra. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kyphoplasty with insertion of Sctructured Titanium Microspheres | Device | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriele Costantino | Contact | 3339088839 | +39 | gabriele.costantino@arnascivico.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gabriele Costantino | Recruiting | Palermo | PA | 90100 | Italy |
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| ID | Term |
|---|---|
| D016103 | Spinal Fractures |
| ID | Term |
|---|---|
| D013124 | Spinal Injuries |
| D019567 | Back Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| ID | Term |
|---|---|
| D058498 | Kyphoplasty |
| ID | Term |
|---|---|
| D054854 | Vertebroplasty |
| D060826 | Cementoplasty |
| D019637 | Orthopedic Procedures |
| D013812 | Therapeutics |
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Prospective Rondomized Open Blinded End Point
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|
| Kyphoplasty with Polimethylmetacrilate (convetional surgery) | Device | 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. |
|
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 |
| D013514 |
| Surgical Procedures, Operative |