Parc Taulí is leading a clinical trial to evaluate the clinical and economic benefits of 3D digital surgery

• The main objective is to demonstrate that this technology not only generates benefits for the patient, but also reduces time and saves resources in the medical center

• The results will determine whether digital surgery can become a standardized practice in the public health system

Parc Taulí has ​​started a clinical trial multicenter, randomized and prospective for evaluate the clinical and economic impact of 3D digital surgery in the field of traumatology and orthopedic surgery. The main goal is to demonstrate that virtual planning combined with 3D printing of customized surgical instrumentation not only brings benefits to the patient, but also reduces time and saves resources in the medical center compared to conventional surgery.

The study is led by 3D Laboratory of Parc Taulí and has the collaboration of reference institutions such as the Hospital Clínic de Barcelona, ​​the Fundació Hospital Olot, the Fundació Privada Hospital Asil Granollers, the Hospital de la Santa Creu i Sant Pau, the Consorci Hospitalari de Vic, and the Maresme and Selva Health Corporation. The Health Quality and Assessment Agency of Catalonia (AQuAS) will carry out the assessment and follow-up, and the Health and Social Consortium of Catalonia (CSC) will coordinate.

Will work with one planned sample of 180 patients aged between 18 and 80 from the seven centers involved, and these will be divided into two groups: an experimental group treated with 3D digital surgery and a control group treated with conventional surgery. The surgical procedures studied will be radius osteotomy, a technique used to correct malformations of the radius; acetabular hip arthroplasty, to treat wear and tear in the hip by replacing the components of the joint; and spinal arthrodesis, which fuses vertebrae to treat pain caused by fractures or degenerative diseases.

During the study, variables such as surgical accuracy, pain reduction, surgeon satisfaction, functionality, intra- and postoperative complications and associated costs will be measured. The results obtained will allow to determine if digital surgery is a profitable methodology and, therefore, it can become a common and standardized practice in the rest of the country's hospitals.

A transformative project

The clinical trial is framed within the 3DApt, a transformative project developed by Parc Taulí and financed by the Catalan Health Service that seeks generate evidence to scale 3D digital surgery in the public health system.

Currently, surgical planning often cannot be performed outside the operating room. This is due to the fact that the two-dimensional medical images, such as CT scan or magnetic resonance imaging, they do not accurately reflect the three-dimensionality of the body's anatomy. "This makes the entire medical procedure difficult and leads to longer surgical times, possible intraoperative complications and an excessive use of resources that have a negative impact on both the patient and the hospital", says Dr. Ferran Fillat, dmedical director of the 3D Digital Surgery Unit at Parc Taulí and principal investigator of the study. 

In this sense, according to Fillat, 3D technology has gained weight, especially in orthopedic surgery and traumatology, because "allows you to create accurate anatomical models and personalized surgical guides based on patient images, and digitally simulate the surgical procedure, improving precision and reducing the margin of error”.

However, widespread adoption of this technology is still hampered by its cost and the lack of large-scale clinical evidence. "Many surgeons continue to use conventional techniques in 2D and the limited precision of these approaches often leads to deviations from the initial planning, increasing the risk of complications", explains Fillat.