Ricoh USA and Stratasys announced enrollment of the first patient in a clinical study to assess use of 3D-printed models for orthopedic oncology.
The patient-specific, 3D-printed anatomical models will be evaluated for preoperative planning and tumor excision compared to solely CT or MRI imaging. The joint research’s goal is to show improvements in surgical outcomes like reduced blood loss, shorter operating time including time under anesthesia, and lowered procedural complication risk.
Unlike the limitations of computer images, using 3D-printed models lets doctors represent vital aspects of anatomy with life-size physical replicas so they can simulate procedures and aid in their precision of excision, ultimately reducing the chances of a positive margin. Ricoh and Stratasys first joined forces to provide on-demand 3D-printed anatomic models for clinical settings in March 2023.
The prospective, multicenter, randomized controlled study expects to run for 12 months with 150 subjects at three trial sites. So far, The Ohio State University Wexner Medical Center and Michigan’s Corewell Health have agreed to participate.
"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 Medical at Stratasys.
Gary Turner, Managing Director, Additive Manufacturing, Ricoh USA, added, "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."