Evaluating the AtMoves Knee System for Diagnosing Loosening After Total Knee Replacement in Routine Care

What this Trial Is About

Researchers are evaluating the AtMoves Knee System to improve the diagnosis of aseptic loosening in patients who have received a total knee replacement. The main goal is to find out if using this specialized device during a CT scan can reduce the number of failed outcomes, defined by patient-reported knee function scores not showing meaningful improvement at 12 months. The study compares two groups to see if the AtMoves Knee System helps in clinical diagnosis and treatment decisions. Participants are randomly assigned to one of two groups. The intervention group undergoes a CT scan using the AtMoves Knee System, which applies specific forces to detect movement of the knee prosthesis component. Both groups continue with diagnostic and treatment plans determined by their orthopedic surgeons, with the control group not receiving the specialized CT scan. This allows researchers to assess the added value of the AtMoves system in routine clinical care. During the one-year follow-up period, participants complete questionnaires about their knee function. Researchers will track the percentage of failed outcomes, revision surgeries, diagnostic activities, related costs, medical use after diagnosis, societal productivity loss, and participant satisfaction with the AtMoves procedure. The study aims to provide a comprehensive evaluation of this diagnostic tools impact on patient outcomes and healthcare use.

DIGITAL-KNEE Study: Adequately Diagnosing Total Knee Arthroplasty Loosening by Evaluating the AtMoves Knee System in a Routine Clinical Setting