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Technologies 3D are demonstrating enormous potential for innovation in the field of surgery,introducing the concept of "treatment customization" (from planning surgery to implant design and manufacturing) on the patient's anatomy, simply by taking advantage of the patient's own common diagnostic images and the flexibility of 3D printing. In fact, this new construction technology allows the construction of the complex anatomical geometries with economy, simplicity and on scales of production unattainable by other traditional technologies. This new construction technology allows, in fact, the construction of complex anatomical geometries with economy, simplicity and on scales of production unattainable by other traditional technologies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pelvic bone neoplasm | Experimental | Patients with primary tumor of the pelvic bone; Primary meta-diaphysial tumor of the long bones; squamous cell carcinoma of the oral cavity involving the maxillary upper and/or lower. |
|
| Sarcoma pediatric patients | Experimental | Patients with primary sarcoma of bone and soft parts involving the scapula, the pelvis and upper and lower limbs; brain tumor. |
|
| Intracranial oncologic pathology | Experimental | Patients with intracranial oncologic pathology with bone involvement and lesions of the skull theca primary or secondary. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D printer applications | Device | Patients will undergo TC/MRI as per routinary care. Custom 3D-devices will be printed on the basis of these images. The device will be used to establish pre-operative surgical options in terms of tissue/bones demolition/reconstruction. |
| Measure | Description | Time Frame |
|---|---|---|
| 3D model feasibility for pre-surgical making decisions | Number of cases in which the time interval between prescription and delivery of the device exceeds 20 days | through study completion, an average of 1 year |
| Surgical time | Number of procedures in which the surgical outcome can be considered optimal (taking planning as a reference) by comparing CT images and evaluating the margins at final histologic analysis. | through study completion, an average of 1 year |
| Device feasibility | Proportion of failed surgeries due to a positive or contaminated finding of the margin of bone resection on final histological examination. verified by comparing the expected outcome (i.e., planning output) and the actual outcome (on the postoperative CT scan). | through study completion, an average of 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kathleen McGreevy, PhD | Contact | 055 5662644 | kathleen.mcgreevy@meyer.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Ospedaliero-Universitaria Careggi (AOUC) | Active, not recruiting | Florence | Italy | |||
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Oncologic patients
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| Meyer Children's Hospital IRCCS |
| Recruiting |
| Florence |
| Italy |
|
| Azienda Ospedaliero Universitaria Senese (AOUS) | Active, not recruiting | Siena | Italy |
| ID | Term |
|---|---|
| D012509 | Sarcoma |
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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