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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCorporacion Parc Tauli

About this trial

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.

Eligibility criteria

Qualifiers

None

Disqualifiers

Patients that are not able to read, understand or sign the consent form.

Patients that can't or have no support to complete the clinical trial.

Patients with complex deformities or complications that would require mandatory personalized digital surgery treatment

Trial design

Treatments tested in this trial

  • patients treated using 3D technology and Patient-Specific Instrumentation
  • Patients treated with conventional surgery, without using 3D technology

Treatment groups

180 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Corporacion Parc Tauli

Lead sponsor

Hospital Clinic of Barcelona

Collaborator

Hospital de Granollers

Collaborator

Fundació Hospital d'Olot i Comarcal de la Garrotxa

Collaborator

Hospital de la Santa creu i Sant Pau - Barcelona

Collaborator

Consorci Hospitalari de Vic

Collaborator

Corporació de Salut del Maresme i la Selva

Collaborator