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

Launched by RICOH USA, INC. · Apr 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how 3D printed models can help doctors plan surgeries for patients with certain types of bone tumors, such as sarcomas. The goal is to see if these models can make surgeries quicker and safer by providing better guidance during the operation. The study will involve around 150 participants over the course of about a year, with some using the 3D models and others relying only on traditional imaging techniques, like X-rays or MRIs, for their surgical planning.

To be eligible for this trial, participants need to be at least 22 years old and have tumors that are affecting their bones and require surgery. They must be able to give consent to participate and be willing to undergo imaging tests to create the 3D models. However, pregnant or nursing women, individuals with serious health issues, and those with certain medical conditions are not eligible. Participants can expect to be randomly assigned to one of the two groups, and the researchers will track various aspects of the surgery, such as how long it takes and any complications that may arise. This study aims to improve surgical outcomes and make the planning process easier for surgeons.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Subjects must be at least 22 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.