A non‐interventional study to evaluate the safety and effectiveness of a biphasic, chondrocyte‐containing biomaterial (NOVOCART® 3D) in the treatment of localized full‐thickness cartilage defects or osteochondral lesions of the knee joint (NISANIK)

Purpose The focus of this study was to evaluate the safety and efficacy of NOVOCART® 3D‐treatment over a period of 36 months post‐transplantation. 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 cartilage defects in the knee joint. 80 patients were enroled across 8 study centres and were followed post‐operatively for a duration of 36 months. Safety assessments were conducted throughout the study period, while effectiveness data were evaluated pre‐operatively 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 associated with nominally significant p ‐values from the 12‐month mark onwards. The subgroup analysis revealed that only higher baseline scores and concurrent surgeries negatively impacted outcome parameters. Female sex, retro‐patellar lesions, uncontained lesions, lesions with intralesional osteophytes or osteochondral defects did not exhibit any significant influence. Conclusion 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. Level of Evidence Level II, therapeutic, prospective cohort study.