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This prospective, multi-center, randomized controlled study aims to assess the efficacy of utilizing 3D printed models in preoperative planning for the excision of tumors involving bony structures within the body. The study is expected to last approximately 12 months and involve up to 150 subjects across up to 5 sites. Subjects will be randomized in a 1:1 ratio into either the experimental arm, utilizing 3D printed models and imaging, or the active comparator arm, using only imaging.
Primary endpoint: Operative time of surgical procedure.
Secondary endpoints: Reduction of blood loss, proportion of postoperative adverse events, and negative tumor margins.
Exploratory endpoints: Surgical planning ease, changes in surgical plan, and surgeon satisfaction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Imaging | Active Comparator | Participants in this arm will undergo tumor excision with prior planning utilizing only Imaging (CT or MRI) without development of a 3D printed model |
|
| 3D Printed Anatomic Model | Experimental | Participants in this arm will have tumors excised with prior planning utilizing 3D printed models and Imaging (CT or MRI). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3D Printed Anatomic Model | Device | Patient-specific 3D printed anatomic model for pre-surgical planning |
|
| Measure | Description | Time Frame |
|---|---|---|
| Operative time | Operative time of surgical procedure based on incision and closure time | Incision to closure |
| Measure | Description | Time Frame |
|---|---|---|
| Blood loss | Change in blood loss as determined by estimated blood loss and units of blood transfused (or blood products used) in mL. | Incision to closure |
| Adverse Events | The proportion of ER visits and post operative procedure related adverse events/complications as reported at the 90-day Follow-Up Chart Review. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alexandra Gormley, PhD | Contact | 484-501-0588 | alexandra.gormley@ricoh-usa.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaiser Permanente Oakland Medical Center | Recruiting | Oakland | California | 94611 | United States |
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| ID | Term |
|---|---|
| D012512 | Sarcoma, Ewing |
| D002813 | Chondrosarcoma |
| D012516 | Osteosarcoma |
| D018219 | Histiocytoma, Benign Fibrous |
| D005354 | Fibrosarcoma |
| ID | Term |
|---|---|
| D018213 | Neoplasms, Bone Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
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| CT/MRI | Diagnostic Test | Standard imaging type for bony tumors |
|
| Surgery to 90 days post-surgery |
| Tumor margin status | The proportion of negative tumor margins as determined by laboratory analysis. | Post-surgery (+3 days) |
| William Beaumont University Hospital | Recruiting | Royal Oak | Michigan | 48073 | United States |
|
| The Ohio State University Wexner Medical Center | Recruiting | Columbus | Ohio | 43212 | United States |
|
| D009369 | Neoplasms |
| D012509 | Sarcoma |
| D051642 | Histiocytoma |
| D018218 | Neoplasms, Fibrous Tissue |