Stratasys and Ricoh USA announced the enrollment of the first patient in a clinical study aimed to evaluate the use of 3D printed models for orthopedic oncology. The study will assess the efficacy of patient-specific 3D printed anatomical models for preoperative planning and tumor excision in comparison to the current standard of care, which relies solely on CT or MRI imaging.
The joint research aims to demonstrate potential improvements in surgical outcomes, including reduced blood loss, shorter operating time including time under anesthesia, and decreased risk of procedural complications. To do this, clinical outcomes will be compared between an experimental group in which tumors are excised using 3D printed models alongside imaging for planning, and an active comparator group in which tumor excision will be prepped solely with imaging.
The benefits of 3D printed models in preoperative planning are severalfold and positively impact both medical practitioners and patients alike. Doctors and surgeons benefit from improved and more informed presurgical planning and practicing prior to operations, making complex procedures more efficient, economical and faster. Unlike the limitations of computer images, this enables doctors to represent vital aspects of patient anatomy with life-size physical replicas, granting them the means to simulate procedures and aid in their precision of excision, ultimately reducing the chances of a positive margin. In turn, the availability of accurate 3D printed models to better communicate planned procedures, together with a greatly improved surgical process, helps to improve patient outcome and recovery.
The prospective, multi-center randomized controlled study is expected to run for 12 months and involve up to 150 subjects across three sites. The two sites which have agreed at this time to participate are The Ohio State University Wexner Medical Center and Corewell HealthTM, based in Michigan.
