Stratasys and Ricoh USA have announced the enrolment of the first patient in a clinical study that will evaluate the use of 3D printed models for orthopaedic oncology.
The study will assess the efficacy of patient-specific 3D printed anatomical models for preoperative planning and tumour excision in comparison to the current standard of care, which relies solely on CT or MRI imaging. The announcement was made during last week's RAPID + TCT event.
This joint research aims to demonstrate the potential improvements in surgical outcomes - such as reduced blood loss, shorter operating times, and decreased risk of procedural complications - when using 3D printed models. To this end, researchers will compare the clinical outcomes between an experimental group in which tumours are excised using 3D printed models alongside imaging for planning, and an active comparator group in which tumour excision will be prepped solely with imaging.
Due to their service into the healthcare space, Stratasys and Ricoh believe the benefits of 3D printed models in preoperative planning are severalfold, positively impacting both medical practitioners and patients alike. With 3D printed models, they suggest that doctors and surgeons benefit from improved and more informed pre-surgical planning, making complex procedures 'more efficient, economical and faster.' The use of 3D printing can enable doctors to represent vital aspects of patient anatomy with life-size physical replicas, helping them to better simulate procedures and aid in their precision of excision. In turn, this can help to improve patient outcomes and recovery.
“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 tumour removal from bones,” said Erez Ben Zvi, VP Medical at Stratasys.
Gary Turner, Managing Director, Additive Manufacturing, Ricoh USA, Inc., 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 modelling as well as accelerate adoption of this technology to better serve a broader population.”
The clinical study announced jointly by Stratasys and Ricoh USA will be a prospective, multi-centre randomised controlled study. It is expected to run for 12 months and involve up to 150 subjects across three sites, two of which have already been confirmed as The Ohio State University Wexner Medical Center and Corewell Health.
“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.”
“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,” offered 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 utilising the power of patient-specific 3D modelling is a significant step in not only patient education but as an aid to surgeons for more precise surgical procedures.”