Assessment of the Truliant Knee System for Total Knee Replacement in Adults with Knee Conditions A Post-Market Study Collecting Patient Outcomes and Device Performance Data

What this Trial Is About

Researchers are collecting data to assess the safety and effectiveness of the Truliant knee prosthesis used in total knee replacement surgeries. This observational study aims to gather clinical and patient outcomes, including survivorship data, from individuals who have received or will receive this knee device. The study focuses on patients with various knee conditions, such as osteoarthritis, rheumatoid arthritis, and post-traumatic arthritis, who have undergone or will undergo surgery involving the Truliant system. Participants include those enrolled before surgery, those enrolled after surgery who continue to participate prospectively, and those enrolled only retrospectively with no prospective follow-up. The study collects data from medical records and patient follow-ups over an extended period. The Truliant Total Knee System, compatible with Optetrak components, is the device being evaluated. Surgeries are performed by investigators or surgeon sub-investigators following approved device indications. During the study, participants will complete assessments using tools such as the Knee Injury and Osteoarthritis Outcome Score for Joint Replacement KOOS JR, Oxford Knee Score, and Visual Analog Scale VAS for pain at multiple time points from before surgery up to ten years post-surgery. Data collection includes demographic, operative, and postoperative information obtained from medical records and patient responses. This long-term follow-up helps researchers monitor outcomes and device performance over time, with the study expected to continue until 2035.

A Post-Market Domestic (US) and International Data Collection to Assess the Truliant Knee System