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.
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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
Parallel
patients treated using 3D technology and Patient-Specific Instrumentation
Procedure/Surgery3D Digital surgery includes: * 3D Surgical Planning using biomedical engineering software; 3D visualization of the patients anatomy and surgical simulation. * Use of personalized surgical guides created through additive manufacturing. * Use of personalized implants created through additive manufacturing. 3 surgical procedures are studied in this study; radius osteotomy, acetabular arthroplasty and spinal arthrodesis
Patients treated with conventional surgery, without using 3D technology
Procedure/SurgeryConventional surgery includes: * 2D planning using TC and x-rays * Free-hand surgery * Use of generic, non-personalized implants 3 surgical procedures are studied in this study; radius osteotomy, acetabular arthroplasty and spinal arthrodesis
Accuracy of implants location, screw positioning and correction angles in regards the previous clinical planning and positioning reference standards.
CT scan will be performed before and after surgery. Digital Planning will be performed in all cases to determine the right positioning of implants and screws (and deformity angle correction if needed) that the surgeon should achieve. Implant location and screw positioning from post-surgery CT will be measured and accuracy will be obtained by comparing the final positioning and correction with the previous planning and goals. Positioning and corrections measurements in post-surgery CT Scan will also be compared to positioning reference standards to determine the number of cases where the reference safe zone positioning and corrections have been achieved in both, digital and conventional surgery.
Demographic
Pain of patient that undergoes any of the surgical procedures studied in this trial before and after surgery assessed by BPI-SF
Pain will be assessed by BPI-SF before and after surgery and results will be compared between digital and conventional surgery to determine if there are significant results in these clinical outcomes.
Quality of life of patients that undergoes any of the surgical procedures studied in this trial before and after surgery will be assessed by SF-36 questionnaire
Quality of life will be assessed by SF-36 before and after surgery and results will be compared between digital and conventional surgery to determine if there are significant results in these clinical outcomes.
Quality of life of patients that undergoes any of the surgical procedures studied in this trial before and after surgery will be assessed by EQ5D-5L questionnaire
Quality of life will be assessed by EQ5D-5L before and after surgery and results will be compared between digital and conventional surgery to determine if there are significant results in these clinical outcomes.
Click on the lead sponsor to view all of their trials.
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
