Clinical Evaluation and Cost-effectiveness Analysis of 3D Digital Surgery in Traumatology

Digital surgery, in combination with patient specific instrumentation (PSI) is being used more and more in traumatology due to its proven benefits and applications. Nowadays, medical case planning and an optimal preparation before surgery are still a challenge for surgeons. This lack of preparation is translated into longer surgical procedures, potential complications, unnecessary sterilization of materials and a high number of fluoroscopies. 2D techniques such as Magnetic Resonance Imaging (MRI), Computed Tomography (CT) and X-rays remain essential for medical planning, however, in many cases, a 3D visualization is needed to achieve better results, especially in complex cases.The use of personalized medical instruments such as surgical guides has proven to increase clinical accuracy, assuring a better correction of bone deformities, and allowing a more precise location of implants and screw positioning. Furthermore, the use of 3D-printed patient-specific prosthesis can lead to better clinical outcomes as they reduce the number of complications as well as they present a longer lifespan compared to conventional generic implants.Despite the potential of 3D technology in the medical field, there is still a lack of robust studies that compares clinical benefits between digital surgery and conventional 2D surgery, and its economic impact is still unknown. Thus, the investigators propose this randomized, prospective and multi-center clinical study to evaluate the use of 3D technology in traumatology. The aim of this project is to prove that digital surgery is a cost-effective methodology and therefore it should be adopted by the public health system as a gold standard procedure.

NCT Number	NCT06603831
Lead Sponsor	Corporacion Parc Tauli Collaborators: Hospital Clinic of Barcelona, Hospital de Granollers, Fundació Hospital d'Olot i Comarcal de la Garrotxa, Hospital de la Santa creu i Sant Pau - Barcelona, Consorci Hospitalari de Vic, Corporació de Salut del Maresme i la Selva
Conditions	Radius; Deformity, Hip Osteoarthritis, Hip Arthritis, Hip Arthropathy, Spine Injury, Radius; Anomaly, Vertebra; Degeneration, Vertebral Fracture +4 more
Enrollment	180 participants
Start Date	2024-10-21
Primary Completion	2027-12-31 (estimated)
Study Completion	2027-12-31 (estimated)
Updated on ClinicalTrials.gov	2024-11-12