Tests 3D printed bone models to plan surgery for bone tumors
Compares 3D printed models with scans to plan surgery for bone tumors.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning
Key facts
- Where
- Columbus, Oakland, and Royal Oak, United StatesSee the 3 sites
Where in United States
- The Ohio State University -Wexner Medical CenterColumbus, United StatesTaking people
- Kaiser Permanente Oakland Medical CenterOakland, United StatesTaking people
- William Beaumont University HospitalRoyal Oak, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Ricoh USA, Inc.
- Trial code
- NCT06387485
- Record updated
- 6 February 2026
- Original description
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.Read full original descriptionShow less
A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning
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.
Inclusion: 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.
Exclusion: 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 is a poor surgical or poor study candidate which may include, any medical, social or psychological problem that could complicate the procedure; Subjects that have clotting disorders; Subjects that have uncontrolled hypertension; Subjects that are HIV-positive; Pregnant or nursing women; Subjects that have a serious systemic pathology; Subject anatomy has changed substantially since the date medical imaging from which the model is derived was obtained (as applicable).