Study Comparing 3D Digital Surgery and Conventional Surgery for Bone and Spine Conditions Evaluating Clinical Benefits and Cost-Effectiveness in Orthopedic Procedures

What this Trial Is About

Researchers are evaluating the use of 3D digital surgery compared to conventional 2D surgery in traumatology and orthopedic surgery. This study aims to assess the clinical benefits and cost-effectiveness of digital surgery, which uses patient-specific instruments and personalized implants to potentially improve surgical outcomes and reduce complications. The trial focuses on three surgical procedures distal radius osteotomy, acetabular arthroplasty, and spinal arthrodesis. Participants are randomly assigned to either the 3D digital surgery group, which involves 3D surgical planning, personalized surgical guides, and implants made through 3D printing, or the conventional surgery group, which uses 2D imaging, free-hand surgery, and generic implants. The surgery types studied are radius osteotomy, acetabular arthroplasty, and spinal arthrodesis. This is a prospective, multi-center, randomized clinical trial with double masking. Participants will undergo CT scans before surgery and 21 days after surgery to measure implant accuracy and positioning. Pain, quality of life, and functionality are assessed before surgery, 21 days after, and 12 months after surgery using specific questionnaires. Surgical time, materials used, fluoroscopy time, complications, and follow-up visits are also monitored. The study aims to provide evidence on both clinical outcomes and economic impact, with a planned end date in 2027.

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