Randomized, Prospective and Multicenter Clinical Study for the Clinical Evaluation and Cost-effectiveness Analysis of 3D Digital Surgery in Traumatology and Orthopedic Surgery

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

⁃ \- Patients that requires one of the following surgical procedures / interventions: Radius osteotomy due to non-articular metaphyseal malunion Complex acetabular arthroplasty Thoracic-lumbar spine arthrodesis.

• Patients that can understand the clinical study and that are able to read, understand and sign the consent form

Locations
Other Locations
Spain
Hospital Parc Taulí
RECRUITING
Sabadell
Contact Information
Primary
Xavier Garcia-Ruz
xgarcia@tauli.cat
644685674
Time Frame
Start Date: 2024-10-21
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 180
Treatments
Experimental: 3D digital surgery group
Active_comparator: 2D conventional surgery group
Sponsors
Collaborators: Hospital Clinic of Barcelona, Hospital de Granollers, Consorci Hospitalari de Vic, Hospital de la Santa creu i Sant Pau - Barcelona, Corporació de Salut del Maresme i la Selva, Fundació Hospital d'Olot i Comarcal de la Garrotxa
Leads: Corporacion Parc Tauli

This content was sourced from clinicaltrials.gov