Study of 3D Printed Models Versus Standard Imaging for Planning Tumor Surgery Involving Bone

What this Trial Is About

Researchers are evaluating the use of 3D printed models in planning surgeries to remove tumors that involve bones. This randomized controlled study will compare the effectiveness of using 3D printed models along with imaging to planning surgery using only imaging techniques such as CT or MRI. The goal is to improve surgical outcomes for patients with bone-invading tumors such as sarcoma and osteosarcoma across multiple centers and sites. Participants will be randomly assigned to one of two groups. One group will have their tumor excision planned using standard imaging techniques only, while the other group will have surgery planned with the help of patient-specific 3D printed anatomic models along with imaging. Both groups will undergo tumor removal surgery, with the study lasting about 12 months and including up to 150 subjects. Throughout the study, researchers will measure the time taken for the surgical procedure from incision to closure as the main outcome. They will also monitor blood loss during surgery, any adverse events up to 90 days after surgery, and whether the tumor was completely removed with negative margins. Additional assessments will include how easy the surgical planning was, any changes made to the plan, and the surgeons satisfaction. Participants will undergo required imaging and surgery, with follow-up to assess safety and outcomes.

A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning