A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning
Summary
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.
Arms & interventions
- Device3D Printed Anatomic Model
Patient-specific 3D printed anatomic model for pre-surgical planning
- Diagnostic TestCT/MRI
Standard imaging type for bony tumors
Outcome measures
Primary
Operative time
Operative time of surgical procedure based on incision and closure time
Time frame: Incision to closure
Secondary
Blood loss
Time frame: Incision to closure
Adverse Events
Time frame: Surgery to 90 days post-surgery
Tumor margin status
Time frame: Post-surgery (+3 days)
Eligibility criteria
Study locations (3)
Kaiser Permanente Oakland Medical Center
Oakland, California, 94611
William Beaumont University Hospital
Royal Oak, Michigan, 48073
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43212