Evaluating EMPHASYS Acetabular Cup Placement Using VELYS Hip Navigation in Total Hip Replacement Surgery

What this Trial Is About

This research focuses on patients undergoing total hip replacement surgery to study the placement of the EMPHASYS acetabular shell hip cup using a non-invasive surgical navigation system called the VELYS hip navigation system with CUPTIMIZE Advanced Hip-Spine Analysis software. The study compares clinical and X-ray data from this method with data from other cup positioning techniques to evaluate performance in conditions like osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis of the femoral head, and ankylosis cases. Participants will receive a primary uncemented hip replacement using the EMPHASYS cup combined with CORAIL, EMPHASYS, or ACTIS stems via specified surgical approaches, guided by the VELYS navigation system. The study collects data on surgical positioning accuracy, including cup inclination and version, and operational times. The treatment is delivered during surgery, and performance is assessed at specific time points postoperatively. Throughout the study, participants will undergo follow-up assessments up to 12 weeks after surgery, including radiographic evaluations, hip function scores, patient questionnaires on joint awareness and quality of life, and monitoring of complications within 30 and 90 days. Researchers will measure how accurately the cup is positioned at 6 weeks as the primary outcome, along with secondary outcomes like hip scores and radiographic results. Participation involves completing questionnaires and clinical visits according to the study schedule.

EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))