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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
150
Patient-specific 3D printed anatomic model for pre-surgical planning
Standard imaging type for bony tumors
Kaiser Permanente Oakland Medical Center
Oakland, California, United States
RECRUITINGWilliam Beaumont University Hospital
Royal Oak, Michigan, United States
RECRUITINGThe Ohio State University Wexner Medical Center
Columbus, Ohio, United States
RECRUITINGOperative time
Operative time of surgical procedure based on incision and closure time
Time frame: Incision to closure
Blood loss
Change in blood loss as determined by estimated blood loss and units of blood transfused (or blood products used) in mL.
Time frame: Incision to closure
Adverse Events
The proportion of ER visits and post operative procedure related adverse events/complications as reported at the 90-day Follow-Up Chart Review.
Time frame: Surgery to 90 days post-surgery
Tumor margin status
The proportion of negative tumor margins as determined by laboratory analysis.
Time frame: Post-surgery (+3 days)
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