Long-Term Follow-Up Study on Safety and Effectiveness of CartiONE Treatment for Knee Cartilage Lesions

What this Trial Is About

Researchers are evaluating the CartiONE technique combined with a biodegradable, biocompatible scaffold PolyActive for treating symptomatic focal cartilage lesions in the knee. This study collects retrospective baseline and follow-up data from patients treated with CartiONE between 2010 and 2023 across five countries to assess the clinical effectiveness and safety of this autologous articular-chondrocyte-based treatment. The study involves patients who received the CartiONE treatment more than six months ago. Data include patient medical histories, surgical reports, posttreatment observations, and any re-intervention records. The trial is retrospective, open-label, and single-arm, focusing on assessing treatment failure rates, adverse events, and cartilage defect volume fill via MOCART scoring over up to two years. Participants medical records will be reviewed for safety outcomes and cartilage repair quality, including effectiveness and quality-of-life questionnaires. The primary outcomes are adverse events and cartilage defect volume fill measured at multiple timepoints from baseline to two years. The study aims to combine questionnaire scores across patients and includes radiologists knee status assessments to support evaluation.

Effectiveness and Safety of Knee Cartilage Lesion Treatment Using CartiONE: 1-to-13 Year Follow-up.