A Post-market Observational ORIGIN4 vs. VANGUARD4 PS Clinical Study: a Comparative, Prospective, Randomized Controlled Clinical and Radiological Evaluation

What this Trial Is About

Researchers are evaluating patient satisfaction and clinical outcomes after total knee replacement surgery using two different devices: a patient-specific implant called the ORIGIN4 System and an off-the-shelf device named the VANGUARD PS System. This observational study is prospective, comparative, randomized, and involves two groups, with 140 patients followed over two years to assess device performance and patient experience. Participants undergo surgery with either the ORIGIN PS System or the VANGUARD PS System, with 70 patients in each group. The study is conducted at a single center and follows patients for two years after surgery, collecting data at preoperative, one-year, and two-year visits. The study compares clinical and radiological outcomes between these two knee replacement devices. During the study, patients complete several assessments including the Forgotten Joint Score and the Self-Administered Patient Satisfaction Scale, both measured before surgery and at one and two years after surgery. Additional evaluations include the Oxford Knee Score, quality of life measures (EQ-5D-5L), Knee Society clinical ratings, and physical function tests like the Single Leg Stance and Time Up & Go tests. These measures help document both patient satisfaction and functional performance over time.

ORIGIN® vs. VANGUARD® PS Observational Study