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膝关节自体软骨细胞移植与微骨折术的比较:一项随机试验

Autologous chondrocyte implantation compared with microfracture in the knee. A randomized trial.

作者信息

Knutsen Gunnar, Engebretsen Lars, Ludvigsen Tom C, Drogset Jon Olav, Grøntvedt Torbjørn, Solheim Eirik, Strand Torbjørn, Roberts Sally, Isaksen Vidar, Johansen Oddmund

机构信息

Department of Orthopaedic Surgery, University Hospital Tromsø, 9038 Tromsø, Norway.

出版信息

J Bone Joint Surg Am. 2004 Mar;86(3):455-64. doi: 10.2106/00004623-200403000-00001.

Abstract

BACKGROUND

New methods have been used, with promising results, to treat full-thickness cartilage defects. The objective of the present study was to compare autologous chondrocyte implantation with microfracture in a randomized trial. We are not aware of any previous randomized studies comparing these methods.

METHODS

Eighty patients without general osteoarthritis who had a single symptomatic cartilage defect on the femoral condyle in a stable knee were treated with autologous chondrocyte implantation or microfracture (forty in each group). We used the International Cartilage Repair Society, Lysholm, Short Form-36 (SF-36), and Tegner forms to collect data. An independent observer performed a follow-up examination at twelve and twenty-four months. Two years postoperatively, arthroscopy with biopsy for histological evaluation was carried out. The histological evaluation was done by a pathologist and a clinical scientist, both of whom were blinded to each patient's treatment.

RESULTS

In general, there were small differences between the two treatment groups. At two years, both groups had significant clinical improvement. According to the SF-36 physical component score at two years postoperatively, the improvement in the microfracture group was significantly better than that in the autologous chondrocyte implantation group (p = 0.004). Younger and more active patients did better in both groups. There were two failures in the autologous chondrocyte implantation group and one in the microfracture group. No serious complications were reported. Biopsy specimens were obtained from 84% of the patients, and histological evaluation of repair tissues showed no significant differences between the two groups. We did not find any association between the histological quality of the tissue and the clinical outcome according to the scores on the Lysholm or SF-36 form or the visual analog scale.

CONCLUSIONS

Both methods had acceptable short-term clinical results. There was no significant difference in macroscopic or histological results between the two treatment groups and no association between the histological findings and the clinical outcome at the two-year time-point.

LEVEL OF EVIDENCE

Therapeutic study, Level I-1a (randomized controlled trial [significant difference]). See Instructions to Authors for a complete description of levels of evidence.

摘要

背景

已采用新方法治疗全层软骨缺损,效果 promising。本研究目的是在一项随机试验中比较自体软骨细胞移植与微骨折术。我们不知道此前有任何比较这两种方法的随机研究。

方法

80例无全身性骨关节炎、膝关节稳定且股骨髁有单一症状性软骨缺损的患者接受了自体软骨细胞移植或微骨折术治疗(每组40例)。我们使用国际软骨修复协会、Lysholm、简明健康调查问卷(SF - 36)和Tegner量表收集数据。一名独立观察者在12个月和24个月时进行随访检查。术后两年,进行关节镜检查并取活检进行组织学评估。组织学评估由一名病理学家和一名临床科学家进行,他们均对每位患者的治疗情况不知情。

结果

总体而言,两个治疗组之间差异较小。两年时,两组临床均有显著改善。根据术后两年的SF - 36身体成分评分,微骨折组的改善明显优于自体软骨细胞移植组(p = 0.004)。两组中年龄较小且活动较多的患者效果更好。自体软骨细胞移植组有2例失败,微骨折组有1例失败。未报告严重并发症。84%的患者获取了活检标本,修复组织的组织学评估显示两组之间无显著差异。根据Lysholm或SF - 36量表评分或视觉模拟量表,我们未发现组织的组织学质量与临床结果之间存在任何关联。

结论

两种方法的短期临床结果均可接受。两个治疗组在宏观或组织学结果上无显著差异,且在两年时间点组织学结果与临床结果之间无关联。

证据水平

治疗性研究,I - 1a级(随机对照试验[有显著差异])。有关证据水平的完整描述见作者须知。

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