一项评估双相含软骨细胞生物材料（NOVOCART®3D）治疗膝关节局部全层软骨缺损或骨软骨病变的安全性和有效性的非介入性研究（NISANIK）

IF 2.7 Q2 ORTHOPEDICS

Journal of Experimental Orthopaedics Pub Date : 2025-08-13 DOI:10.1002/jeo2.70346

Julia Elisabeth Lenz, Johannes Weber, Johannes Zellner, Gerald Zimmermann, Peter E. Müller, Alexander Barié, Dominik Popp, Sven Ostermeier, Tilmann Krackhardt, Julian Mehl, Volker Alt, Peter Angele

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引用次数: 0

摘要

目的：本研究的重点是评估移植后36个月NOVOCART®3d治疗的安全性和有效性。方法本研究是一项前瞻性、多中心、单臂、非介入研究，旨在评估NOVOCART®3D治疗膝关节局部软骨缺损患者的安全性和有效性。来自8个研究中心的80名患者入组，术后随访36个月。在整个研究期间进行安全性评估，同时利用国际膝关节文献委员会2000评分（IKDC 2000）评估术前和细胞移植后3、12、18、24和36个月的有效性数据。结果80例患者在3年的观察期内，手术或产品相关不良事件的发生率为12.5%。根据IKDC 2000的主观评分显示出改善，在36个月时从基线的平均变化为30.5±21.5分。同样，IKDC功能平均评分也持续提高，平均差值为3.2±3.0分。从基线开始的这些变化与从12个月开始的名义显著p值相关。亚组分析显示，只有较高的基线评分和同时进行的手术对结果参数有负面影响。女性、髌骨后病变、未包含病变、病灶内骨赘或骨软骨缺损的病变未表现出任何显著影响。结论NISANIK研究表明NOVOCART®3D治疗是安全的。关于有效性，研究中的患者与术前相比表现出显著且逐渐增加的平均改善。该研究进一步表明，NOVOCART®普遍适用于所有年龄组和体重指数范围，它也可以有效地用于女性、较大病变、髌后病变以及接受植骨手术而不影响结果的患者，与相关手术不同。证据水平：II级，治疗性，前瞻性队列研究。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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)

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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.