Stratasys and Ricoh USA have announced the enrolment of the first patient in a clinical study aimed to evaluate the use of 3D printed models for orthopaedic oncology.
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Clinical study
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 joint research aims to demonstrate potential improvements in surgical outcomes, including reduced blood loss, shorter operating time including time under anaesthesia, and decreased risk of procedural complications. To do this, clinical outcomes will be compared 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.
Benefits for medical staff and patients
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-centre randomised 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 Health, 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, 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, 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.”