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

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.

Conditions

• Radius; Deformity
• Hip Osteoarthritis
• Hip Arthritis
• Hip Arthropathy
• Spine Injury
• Radius; Anomaly
• Vertebra; Degeneration
• Vertebral Fracture
• Hip Prosthesis Infection
• Spinal Fusion
• Spine Osteoarthritis
• Spinal Deformity

Interventions

PROCEDURE

patients treated using 3D technology and Patient-Specific Instrumentation

3D 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

PROCEDURE

Patients treated with conventional surgery, without using 3D technology

Conventional 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

Sponsors & Collaborators

• Hospital Clinic of Barcelona

  collaborator OTHER

• Hospital de Granollers

  collaborator OTHER

• Fundació Hospital d'Olot i Comarcal de la Garrotxa

  collaborator UNKNOWN

• Hospital de la Santa creu i Sant Pau - Barcelona

  collaborator OTHER

• Consorci Hospitalari de Vic

  collaborator OTHER

• Corporació de Salut del Maresme i la Selva

  collaborator OTHER

• Corporacion Parc Tauli

  lead OTHER

Principal Investigators

• Ferran Fillat-Gomà · Corporacion PT

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-21

Primary Completion

2027-12-31

Completion

2027-12-31

Countries

• Spain

Study Locations