Actively Recruiting

Phase Not Applicable
Age: 18Years - 80Years
All Genders
NCT06603831

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

Led by Corporacion Parc Tauli · Updated on 2024-11-12

180

Participants Needed

1

Research Sites

166 weeks

Total Duration

On this page

Sponsors

C

Corporacion Parc Tauli

Lead Sponsor

H

Hospital Clinic of Barcelona

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients requiring one of the following surgeries: radius osteotomy for non-articular metaphyseal malunion, complex acetabular arthroplasty, or thoracic-lumbar spine arthrodesis
  • Patients able to understand the clinical study and able to read, understand, and sign the consent form
Not Eligible

You will not qualify if you...

  • Patients unable to read, understand, or sign the consent form
  • Patients lacking support to complete the clinical trial
  • Patients with complex deformities or complications requiring mandatory personalized digital surgery treatment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital Parc Taulí

Sabadell, Barcelona, Spain, 08208

Actively Recruiting

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Research Team

X

Xavier Garcia-Ruz

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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