Using 3D printed models for planning bone tumor surgeries

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

This study is testing if using 3D printed models can help doctors plan surgeries for bone tumors better than just using imaging alone.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 150 (estimated)
• Ages: 13 Years and up
• Sex: All
• Sponsor: Ricoh USA, Inc. (industry)
• Locations: 3 sites (Oakland, California and 2 other locations)
• Trial ID: NCT06387485 on ClinicalTrials.gov

What this trial studies

This prospective, multi-center, randomized controlled study evaluates the effectiveness of 3D printed models in preoperative planning for the surgical excision of bony tumors. The study will involve up to 150 participants who will be randomly assigned to either use 3D printed models alongside imaging or rely solely on imaging for surgical planning. The primary goal is to assess the impact on operative time, while secondary outcomes include blood loss, postoperative complications, and tumor margin status. The study is expected to last approximately 12 months across three medical centers.

Who should consider this trial

Good fit: Ideal candidates are adults aged 22 and older with tumors invading bone that require surgical excision.

Not a fit: Patients who are pregnant, have serious systemic pathologies, or have uncontrolled health conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more efficient surgeries with reduced operative times and improved patient outcomes.

How similar studies have performed: While the use of 3D printing in surgical planning is gaining traction, this specific approach is relatively novel and has not been extensively tested in similar studies.

Eligibility criteria

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.

Where this trial is running

Oakland, California and 2 other locations

• Kaiser Permanente Oakland Medical Center — Oakland, California, United States (RECRUITING)
• William Beaumont University Hospital — Royal Oak, Michigan, United States (RECRUITING)
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States (RECRUITING)

Study contacts

• Study coordinator: Alexandra Gormley, PhD

Conditions: Sarcoma, Ewing, Chondrosarcoma, Osteosarcoma, Fibrous Histiocytoma, Fibrosarcoma, bony tumor