Kreuz Peter C, Müller Sebastian, Ossendorf Christian, Kaps Christian, Erggelet Christoph
Department of Orthopaedic and Trauma Surgery, University Medical Center Rechts der Isar of the Technical University Munich, Munich, Germany.
Arthritis Res Ther. 2009;11(2):R33. doi: 10.1186/ar2638. Epub 2009 Mar 5.
Second-generation autologous chondrocyte implantation with scaffolds stabilizing the grafts is a clinically effective procedure for cartilage repair. In this ongoing prospective observational case report study, we evaluated the effectiveness of BioSeed-C, a cell-based cartilage graft based on autologous chondrocytes embedded in fibrin and a stable resorbable polymer scaffold, for the treatment of clinical symptomatic focal degenerative defects of the knee.
Clinical outcome after 4-year clinical follow-up was assessed in 19 patients with preoperatively radiologically confirmed osteoarthritis and a Kellgren-Lawrence score of 2 or more. Clinical scoring was performed before implantation of the graft and 6, 12, and 48 months after implantation using the Lysholm score, the Knee injury and Osteoarthritis Outcome Score (KOOS), the International Knee Documentation Committee (IKDC) score, and the International Cartilage Repair Society (ICRS) score. Cartilage regeneration and articular resurfacing were assessed by magnetic resonance imaging (MRI) 4 years after implantation of the autologous cartilage graft.
Significant improvement (P < 0.05) of the Lysholm and ICRS scores was observed as early as 6 months after implantation of BioSeed-C and remained stable during follow-up. The IKDC score showed significant improvement compared with the preoperative situation at 12 and 48 months (P < 0.05). The KOOS showed significant improvement in the subclasses pain, activities of daily living, and knee-related quality of life 6 months as well as 1 and 4 years after implantation of BioSeed-C in osteoarthritic defects (P < 0.05). MRI analysis showed moderate to complete defect filling with a normal to incidentally hyperintense signal in 16 out of 19 patients treated with BioSeed-C. Two patients without improvement in the clinical and MRI scores received a total knee endoprosthesis after 4 years.
The results show that the good clinical outcome achieved 1 year after implantation of BioSeed-C remains stable over the course of a period of 4 years and suggest that implanting BioSeed-C is a promising treatment option for the repair of focal degenerative defects of the knee.
采用稳定移植物的支架进行第二代自体软骨细胞植入是一种临床上有效的软骨修复方法。在这项正在进行的前瞻性观察病例报告研究中,我们评估了BioSeed-C的有效性,BioSeed-C是一种基于自体软骨细胞并嵌入纤维蛋白和稳定可吸收聚合物支架的细胞基软骨移植物,用于治疗膝关节临床症状性局灶性退行性缺损。
对19例术前经放射学确诊为骨关节炎且Kellgren-Lawrence评分为2分或更高的患者进行了4年临床随访后的临床结果评估。在植入移植物前以及植入后6、12和48个月使用Lysholm评分、膝关节损伤和骨关节炎结局评分(KOOS)、国际膝关节文献委员会(IKDC)评分以及国际软骨修复协会(ICRS)评分进行临床评分。在自体软骨移植物植入4年后,通过磁共振成像(MRI)评估软骨再生和关节表面修复情况。
早在植入BioSeed-C后6个月,就观察到Lysholm和ICRS评分有显著改善(P < 0.05),且在随访期间保持稳定。与术前情况相比,IKDC评分在12个月和48个月时显示出显著改善(P < 0.05)。在骨关节炎缺损患者中,BioSeed-C植入后6个月以及1年和4年时,KOOS在疼痛、日常生活活动和膝关节相关生活质量亚类方面显示出显著改善(P < 0.05)。MRI分析显示,在接受BioSeed-C治疗的19例患者中,有16例出现中度至完全缺损填充,信号正常至偶然出现高信号。两名临床和MRI评分未改善的患者在4年后接受了全膝关节置换术。
结果表明,BioSeed-C植入1年后取得的良好临床效果在4年期间保持稳定,这表明植入BioSeed-C是修复膝关节局灶性退行性缺损的一种有前景的治疗选择。