Clinical Study Evaluates Use of Patient-specific 3D-printed Anatomical Models

Patient-specific 3D-printed surgical models is a growing market — in the double digits, according to some analysts — and that makes a whole lot of sense. 3D-printed models benefit the surgeon, who can conduct hands-on pre-operative planning, as well as the patient through better outcomes and faster recovery. 3D-printing pioneer Stratasys Ltd., in partnership with digitalization expert Ricoh USA, hopes to back that up with data from a clinical study evaluating the use of 3D-printed models for orthopedic oncology. The companies announced this week enrollment of the first patient in the study, which is expected to run for 12 months and involve up to 150 subjects.

A better model?

The current standard of care in orthopedic oncology relies solely on CT or MRI imaging, said Stratasys in the news release. The clinical study aims to show how the use of 3D-printed models can improve surgical outcomes by comparing results from two groups: In the “experimental” group, tumors will be excised using 3D-printed models supported by imaging for surgical planning. In the “comparator” group, surgical preparation solely will be based on imaging.

Patient education tool

According to Stratasys, the use of 3D-printed models makes complex procedures more efficient, faster, and more economical by enabling surgeons to simulate the operation on a life-size physical replica of the patient’s anatomy and more precisely plan excision of the tumor. It can also serve as a valuable tool in patient education. The clinical study hopes to validate these claims with hard data.

So far, two sites have signed up for the randomized controlled study: The Ohio State University Wexner Medical Center and Corewell Health in Michigan. Stratasys and Ricoh USA are looking for a third healthcare facility for the year-long study.