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Ricoh and Stratasys commence orthopedic oncology study

Assessing the efficacy of patient-specific 3D printed anatomical models for preoperative planning and tumor excision

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Ricoh USA and Stratasys have enrolled the first patient in a clinical study 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 medical practitioners and patients. Doctors and surgeons benefit from improved and more informed presurgical planning and practicing before 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 and a greatly improved surgical process helps improve patient outcomes 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 that have agreed at this time to participate are Ohio State University Wexner Medical Center and Corewell HealthTM, based in Michigan.

“Our never-ending mission is to improve patient outcomes, and that starts with preoperative planning,” said Kyle K. VanKoevering, MD Associate Professor, Otolaryngology – Head and Neck Surgery at Ohio State Wexner Medical Center. “We look forward to participating in this study to examine how 3D printed models may help the medical staff better prepare for surgery as well as improve patient education.”

“Being one of the sites to participate in this study puts us on the forefront of demonstrating new technologies that can advance patient care and improve health outcomes,” said Aws Hammad, clinical faculty of orthopedic surgery at Corewell Health William Beaumont University Hospital. “Addressing the challenges that come along with bone sarcomas and utilizing the power of patient-specific 3D modeling is a significant step in not only patient education but as an aid to surgeons for more precise surgical procedures.”

“The collaboration brings together unparalleled experience and innovation in medical imaging and 3D printing and, if successful, may establish anatomical models as a new standard for patient treatment in tumor removal from bones,” said Erez Ben Zvi, VP of Medical at Stratasys.

“We are thrilled to co-sponsor this important clinical trial alongside our longstanding partners at Stratasys to further demonstrate the potential impact of 3D patient-specific modeling as well as accelerate adoption of this technology to better serve a broader population,” said Gary Turner, Managing Director of Additive Manufacturing at Ricoh USA.

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