Study to Assess the Accuracy and Safety of Navigated Total Knee Replacement Using OrthoPilot pheno4u TKA Level 1 Software

What this Trial Is About

Researchers are evaluating the accuracy, safety, and performance of a new software called pheno4uTKA Level 1 for use with the OrthoPilot Elite navigation system during total knee arthroplasty TKA surgery. This study focuses on patients with knee conditions such as osteoarthritis, rheumatoid arthritis, posttraumatic arthropathy, and other joint diseases. Patient-related outcome measures will also be collected to understand functional outcomes and satisfaction after surgery. The study involves performing total knee arthroplasty using the new pheno4uTKA Level 1 software with the OrthoPilot Elite navigation system. This software helps guide the surgeon in preparing the implant site for the knee prosthesis. The study is single-arm and multicenter, meaning all participants will receive the navigated TKA procedure using this software. Participants will be followed for up to two years after surgery. Researchers will assess surgical accuracy by comparing the new software to the previous version three months after surgery. Other evaluations include implant survival, knee function scores Oxford Knee Score and Forgotten Joint Score, quality of life assessments, patient satisfaction scores, anterior knee pain, radiological results, and monitoring for any serious adverse events. Follow-up visits will occur preoperatively and at multiple postoperative time points up to two years.

Study to Evaluate the Performance of Navigated TKA With OrthoPilot® pheno4u TKA Level 1