¹Klinikum und Poliklinik für Unfallchirurgie, Universitätsklinikum Regensburg, Regensburg, Deutschland
²Sporthopaedicum Regensburg, Straubing, Deutschland
³Department of Trauma Surgery, Theresienkrankenhaus, Mannheim, Deutschland
⁴Department of Sports Orthopaedics and Sports Traumatology, University Hospital Heidelberg, Heidelberg, Deutschland
⁵Sportopaedie Heidelberg, Center for Joint Surgery and Sport Injuries, Heidelberg, Deutschland
⁶Klinikum am Bruderwald, Sozialstiftung Bamberg, Bamberg, Deutschland
⁷UOC Bischberg, Bischberg, Deutschland
⁸Orthopaedic Clinic, Gelenk-Klinik Gundelfingen, Gundelfingen, Deutschland
⁹Lubinus Clinicum, Kiel, Deutschland
¹⁰Klinikum rechts der Isar, TUM-Universitätsklinikum, Munich, Deutschland

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Objectives and questions: The focus of this study was to evaluate the safety of NOVOCART^® 3D-treatment over a period of 36 months post-transplantation. The secondary aim was to assess the enhancement of functional abilities and performance in both adult and adolescent patients undergoing treatment with NOVOCART^® 3D.

Material and methods: This study was designed as a prospective, multicenter, single-arm, non-interventional investigation, aimed at evaluating the safety and efficacy of NOVOCART^® 3D in patients with localized, full-thickness cartilage defects in the knee joint. In total, 80 patients were enrolled across 8 study centers in Germany and were followed post-operatively for a duration of 36 months. Safety assessments were conducted throughout the study period, while effectiveness data were routinely evaluated pre-harvesting of cartilage cells and at 3, 12-, 18-, 24-, and 36-months following cell transplantation, utilizing the International Knee Documentation Committee 2000 score (IKDC 2000).

Results: Over the 3-year observation period among the 80 study patients, the incidence of surgery or product related adverse events stood at 12.5%. Subjective scores according to IKDC 2000 demonstrated improvement, with a mean change from baseline of 30.5 ± 21.5 score points at 36 months. Similarly, the mean IKDC function score exhibited continuous enhancement, with a mean difference of 3.2 ± 3.0 score points. These changes from baseline were notably associated with nominally significant p-values from the 12-month mark onwards. There was a consistent increase in responder rates observed over time. The subgroup analysis revealed that higher baseline scores and concurrent surgeries negatively impacted outcome parameters. Demographic characteristics, including female sex, and lesion parameters, such as retro-patellar lesions or osteochondral defects, did not exhibit any significant influence.

Discussion and conclusions: The NISANIK study indicates the safety of NOVOCART^® 3D treatment. Regarding effectiveness, patients in the study demonstrated a notable and progressively increasing mean improvement compared to their pre-operative condition. The study furthermore demonstrated that NOVOCART^® is universally applicable across all age groups and Body Mass Index ranges, and it can also be effectively used in patients with female sex, larger lesions, retro-patellar lesions and in such having received bone-grafting without compromising the outcome, unlike related procedures.