A Study to Evaluate the Utilization of 3D Printed Models in Pre-Operative Planning
Start Date
3/1/2024
Completion Date
7/31/2027
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.
Eligibility Criteria
Age Range: 13 years to No maximum
Interventions
3D Printed Anatomic Model
CT/MRI
Conditions
Locations
Kaiser Permanente Oakland Medical Center
Oakland, California 94611
United States
William Beaumont University Hospital
Royal Oak, Michigan 48073
United States
The Ohio State University Wexner Medical Center
Columbus, Ohio 43212
United States