Stratasys and Ricoh launch clinical trial on 3D printing in orthopaedic oncology

Stratasys Ltd. and Ricoh USA, Inc. have announced the initiation of a clinical trial investigating the use of patient-specific 3D-printed models for orthopedic oncology. This study aims to evaluate the effectiveness of these models for preoperative planning and tumor removal compared to the current standard method based solely on CT or MRI images.

The aim of the joint research is to demonstrate potential improvements in surgical outcomes, including a reduction in blood loss, shorter operating times and a lower risk of complications. To this end, the clinical results of a test group in which tumors are removed using 3D-printed models will be compared with those of a comparison group that relies solely on imaging procedures.

“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, 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.”

The advantages of 3D-printed models for pre-operative planning are manifold and affect both medical staff and patients. Surgeons benefit from improved and more informed pre-operative planning, making complex procedures more efficient and cost-effective. In contrast to the limitations of computer images, the life-size physical replicas allow for a precise representation of patient anatomy, which improves the simulation of procedures and the precision of tumor removal.

“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, M.D., clinical faculty of orthopaedic 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.”

In addition, the accurate 3D printed models will help to better communicate planned procedures and significantly improve the surgical process, positively impacting patient education and recovery.

According to Erez Ben Zvi, VP Medical at Stratasys, “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.”

The prospective, multi-center, randomized controlled trial will run for 12 months and include up to 150 subjects at three sites. The Ohio State University Wexner Medical Center and Corewell Health in Michigan have already agreed to participate.

Gary Turner, Managing Director, Additive Manufacturing, Ricoh USA, Inc., comments, “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.”