Evaluation of 3D Digital Surgery in Traumatology
Randomized, Prospective and Multicenter Clinical Study for the Clinical Evaluation and Cost-effectiveness Analysis of 3D Digital Surgery in Traumatology and Orthopedic Surgery
This study is testing if using 3D digital surgery tools can help patients with orthopedic conditions have better surgery outcomes and fewer complications compared to traditional methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 180 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Corporacion Parc Tauli Academic / other |
| Locations | 1 site (Sabadell, Barcelona) |
| Trial ID | NCT06603831 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and cost-efficiency of 3D digital surgery combined with patient-specific instrumentation in treating various orthopedic conditions. It aims to improve surgical planning and outcomes by utilizing 3D visualization and custom-made surgical guides and implants. Patients undergoing procedures such as radius osteotomy and complex acetabular arthroplasty will be compared against those receiving conventional surgery. The study seeks to demonstrate that 3D technology can enhance surgical precision and reduce complications.
Who should consider this trial
Good fit: Ideal candidates include patients requiring specific surgical interventions like radius osteotomy or complex acetabular arthroplasty who can understand and consent to the study.
Not a fit: Patients with complex deformities or complications necessitating mandatory personalized digital surgery treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and reduced complications for patients undergoing orthopedic surgeries.
How similar studies have performed: Previous studies have shown promising results with the use of 3D technology in surgical planning, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Sabadell, Barcelona
- Hospital Parc Taulí — Sabadell, Barcelona, Spain (Recruiting)
Study contacts
- Principal investigator: Ferran Fillat-Gomà — Corporacion PT
- Study coordinator: Xavier Garcia-Ruz
- Email: xgarcia@tauli.cat
- Phone: 644685674
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.