Articular cartilage engineering with Hyalograft® C -: 3-year clinical results
Articular cartilage engineering with Hyalograft® C -: 3-year clinical results
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DOI：
10.1097/01.blo.0000165737.87628.5b
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发表时间：
2005-06-01
影响因子：
4.2
通讯作者：
Zanasi, S
中科院分区：
文献类型：
--
作者：
Marcacci, M;Berruto, M;Zanasi, S
组织工程用于软骨修复已成为一种潜在的治疗选择，并导致了Hyalograft(R) C的发展，这是一种组织工程移植物，由生长在完全由HYAFF(R) 11（透明质酸的酯化衍生物）制成的支架上的自体软骨细胞组成。本文报告了一项正在进行的多中心临床研究的结果，该研究的主要目的是调查玻璃体移植(R) c治疗的患者的主观症状、功能和健康相关的生活质量结果。对141名患者的临床结果进行了随访评估，随访时间为2至5年（平均随访时间：38个月）。在随访中，91.5%的患者根据国际膝关节文献委员会的主观评价得到改善；通过EuroQol-EQ5D评估，76%和88%的患者分别没有疼痛和活动问题。此外，经外科医生评估，95.7%的患者治疗后膝关节正常或接近正常；96.4%的膝关节软骨修复在关节镜下被评为正常或接近正常；大多数移植部位的二次活检在组织学上被评估为透明样。重要的是，本研究记录的并发症发生率非常有限。阳性的临床结果表明，透明骨移植(R) C是一种安全有效的治疗关节软骨病变的选择。证据等级：治疗性研究，III-2级（回顾性队列研究）。有关证据水平的完整描述，请参见作者指南。
The use of tissue engineering for cartilage repair has emerged as a potential therapeutic option and has led to the development of Hyalograft(R) C, a tissue-engineered graft composed of autologous chondrocytes grown on a scaffold entirely made of HYAFF(R) 11, an esterified derivative of hyaluronic acid. Here we present the results of an ongoing multicenter clinical study conducted with the primary objective to investigate the subjective symptomatic, functional and health-related quality of life outcomes of patients treated with Hyalograft(R) C. Clinical results on the cohort of 141 patients with followup assessments ranging from 2 to 5 years (average followup time: 38 months), are reported. At followup 91.5% of patients improved according to the International Knee Documentation Committee subjective evaluation; 76% and 88% of patients had no pain and mobility problems respectively assessed by the EuroQol-EQ5D measure. Furthermore, 95.7% of the patients had their treated knee normal or nearly normal as assessed by the surgeon; cartilage repair was graded arthroscopically as normal or nearly normal in 96.4% of the scored knees; the majority of the second-look biopsies of the grafted site histologically were assessed as hyalinelike. Importantly, a very limited complication rate was recorded in this study. The positive clinical results obtained indicate that Hyalograft(R) C is a safe and effective therapeutic option for the treatment of articular cartilage lesions.Level of Evidence: Therapeutic study, Level III-2 (retrospective cohort study). See the Guidelines for Authors for a complete description of levels of evidence.