Adequately Diagnosing Total Knee Arthroplasty Loosening: A Randomized Controlled Trial Evaluating the AtMoves Knee System in a Routine Clinical Setting
The goal of the clinical trial is to evaluate the efficacy of the AtMoves Knee System in the clinical diagnostic process of aseptic loosening in patients with a knee prosthesis. The main question it aims to answer is: Does the use of the AtMoves Knee System reduce the percentage of failed outcomes? A failed outcome is defined as a change in the patient-reported Knee injury and Osteoarthritis Outcome Score (KOOS-PS) that is lower than the minimal clinically important difference at 12 months. Researchers will compare two groups: The first group will undergo an additional CT scan using the AtMoves Knee System. The second group will not undergo these scans. Both groups are allowed to undergo additional diagnostic measures. Researchers will compare the percentage of failed outcomes between these groups. During the one-year follow-up, participants in both groups will be asked to fill out questionnaires.
• Age 18 years or older.
• Subjects must have underwent either unilateral or bilateral TKA surgery.
• Aseptic loosening is one of the differential diagnoses of the treating orthopaedic surgeon
• The treating Orthopaedic Surgeon is uncertain of the diagnosis after anamnesis, physical examination and conventional x-ray.
• The surgeon wants additional examinations or additional imaging to arrive at the diagnosis and proposal for treatment.
• Subjects must be capable of giving informed consent and must be willing to undergo examination with the AtMoves Knee System.