NCT06603831 Clinical Evaluation and Cost-effectiveness Analysis of 3D Digital Surgery in Traumatology
| NCT ID | NCT06603831 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Corporacion Parc Tauli |
| Condition | Radius; Deformity |
| Study Type | INTERVENTIONAL |
| Enrollment | 180 participants |
| Start Date | 2024-10-21 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 180 participants in total. It began in 2024-10-21 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: \- 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 Exclusion Criteria: * 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
Contact & Investigator
Ferran Fillat-Gomà
PRINCIPAL INVESTIGATOR
Corporacion PT
Frequently Asked Questions
Who can join the NCT06603831 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Radius; Deformity. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06603831 currently recruiting?
Yes, NCT06603831 is actively recruiting participants. Contact the research team at xgarcia@tauli.cat for enrollment information.
Where is the NCT06603831 trial being conducted?
This trial is being conducted at Sabadell, Spain.
Who is sponsoring the NCT06603831 clinical trial?
NCT06603831 is sponsored by Corporacion Parc Tauli. The principal investigator is Ferran Fillat-Gomà at Corporacion PT. The trial plans to enroll 180 participants.