Chondrosarcoma, Fibrosarcoma, Fibrous Histiocytoma, Osteosarcoma, Sarcoma, Ewing
Conditions
Keywords
bony tumor
Brief summary
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.
Interventions
DEVICE3D Printed Anatomic Model
Patient-specific 3D printed anatomic model for pre-surgical planning
DIAGNOSTIC_TESTCT/MRI
Standard imaging type for bony tumors
Sponsors
Ricoh USA, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects must be at least 13 years of age. 2. Subjects must have the ability to provide written informed consent. 3. Subjects must have tumor(s) invading bone and requiring surgical excision including but not limited to craniomaxillofacial, spine, long bone, and pelvis. 4. Subjects must be willing to have quality cross-sectional imaging that will allow for use to develop a 3D printed model.
Exclusion criteria
1. Pregnant or nursing women. 2. Subjects that have a serious systemic pathology. 3. Subjects that have clotting disorders. 4. Subjects that have uncontrolled hypertension. 5. Subjects that are HIV-positive. 6. Subjects that are unable to be randomized; i.e surgical team prefers to use either 3D model or standard cross-sectional imaging for surgical pre-planning. 7. Subject anatomy has changed substantially since the date medical imaging from which the model is derived was obtained (as applicable). 8. Subject is a poor surgical or poor study candidate which may include, any medical, social or psychological problem that could complicate the procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Operative time | Incision to closure | Operative time of surgical procedure based on incision and closure time |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood loss | Incision to closure | Change in blood loss as determined by estimated blood loss and units of blood transfused (or blood products used) in mL. |
| Adverse Events | Surgery to 90 days post-surgery | The proportion of ER visits and post operative procedure related adverse events/complications as reported at the 90-day Follow-Up Chart Review. |
| Tumor margin status | Post-surgery (+3 days) | The proportion of negative tumor margins as determined by laboratory analysis. |
Countries
United States
Contacts
CONTACTAlexandra Gormley, PhD
Outcome results
None listed