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

Recruiting now · Not applicable

Conditions studied: Sarcoma, Ewing, Chondrosarcoma, Osteosarcoma, Fibrous Histiocytoma, Fibrosarcoma

In brief

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.

Key facts

Study ID

NCT06387485

Run by

Ricoh USA, Inc.

People needed

150

Starts

2024-03-01

Expected to finish

2027-07-31

Last updated by the study team

2026-02-06

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must be at least 13 years of age.
• Subjects must have the ability to provide written informed consent.
• Subjects must have tumor(s) invading bone and requiring surgical excision including but not limited to craniomaxillofacial, spine, long bone, and pelvis.
• Subjects must be willing to have quality cross-sectional imaging that will allow for use to develop a 3D printed model.

You may not qualify if…

• Pregnant or nursing women.
• Subjects that have a serious systemic pathology.
• Subjects that have clotting disorders.
• Subjects that have uncontrolled hypertension.
• Subjects that are HIV-positive.
• 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.
• Subject anatomy has changed substantially since the date medical imaging from which the model is derived was obtained (as applicable).
• Subject is a poor surgical or poor study candidate which may include, any medical, social or psychological problem that could complicate the procedure.

Where it is running

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

Full record on ClinicalTrials.gov

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