Actively Recruiting
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
Eligibility Criteria
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
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
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Trial Site Locations
Total: 1 location
1
Hospital Parc Taulí
Sabadell, Barcelona, Spain, 08208
Actively Recruiting
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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