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采用原始骨膜覆盖技术的自体软骨细胞移植与基质相关的自体软骨细胞移植:一项随机临床试验。

Autologous chondrocyte implantation using the original periosteum-cover technique versus matrix-associated autologous chondrocyte implantation: a randomized clinical trial.

机构信息

Orthopädische Universitätsklinik Heidelberg, Heidelberg, Germany.

出版信息

Am J Sports Med. 2010 May;38(5):924-33. doi: 10.1177/0363546509351499. Epub 2009 Dec 4.

Abstract

BACKGROUND

Autologous chondrocyte implantation (ACI) is frequently used to treat symptomatic defects of the articular cartilage.

PURPOSE

To test whether matrix-associated autologous chondrocyte implantation or the original periosteal flap technique provides superior outcomes in terms of clinical efficacy and safety.

STUDY DESIGN

Randomized controlled trial; Level of evidence, 2.

METHODS

Twenty-one patients (mean age, 29.3 +/- 9.1 years) with symptomatic isolated full-thickness cartilage defects (mean 4.1 +/- 09 cm2) at the femoral condyle were randomized to matrix-associated autologous chondrocyte implantation or the original periosteal flap technique. The primary outcome parameter was the postoperative change in knee function as assessed by the International Knee Documentation Committee (IKDC) score at 12 months after ACI. In addition, the IKDC score was assessed at 3, 6, 12, and 24 months after surgery. Secondary outcome parameters were postoperative changes in health related quality of life (Short Form-36 Health Survey), knee functionality (Lysholm and Gillquist score), and physical activity (Tegner Activity Score) at 3, 6, 12, and 24 months after ACI. Magnetic resonance imaging was performed to evaluate the cartilage 6, 12, and 24 months after ACI and rated using the Magnetic Resonance Observation of Cartilage Repair Tissue score. Adverse events were recorded to assess safety.

RESULTS

The primary outcome parameter showed improvement of patients 1 year after autologous chondrocyte implantation, but there was no difference between the periosteal flap technique and matrix-associated ACI (P = .5573); 2 years after ACI, a similar result was found (P = .4994). The study groups did not show differences in the Short Form-36 categories and in knee functionality as assessed by Tegner Activity Score 12 months (P = .4063) and 24 months (P = .1043) after ACI. There was a significant difference in the Lysholm and Gillquist score at 12 months (P = .0449) and 24 months (P = .0487) favoring the periosteal flap technique group. At 6 months after surgery, a significantly lower Magnetic Resonance Observation of Cartilage Repair score was obtained in the matrix-associated ACI group (P = .0123), corresponding to more normal magnetic resonance imaging diagnostic findings. Twelve and 24 months after ACI, the differences between the 2 groups were not significant (12 months, P = .2065; 24 months, P = .6926). Adverse events were related to knee problems such as transplant delamination, development of an osseous spur, osteochondral dissection, and transplant hypertrophy. Systemic (allergic, toxic, or autoimmune) reactions did not occur.

CONCLUSION

There was no difference in the efficacy between the original and the advanced ACI technique 12 and 24 months after surgery regarding International Knee Documentation Committee, Tegner Activity Score, and Short Form-36; however, with respect to the Lysholm and Gillquist score, better efficacy was observed in the periosteal flap technique group.

摘要

背景

自体软骨细胞移植(ACI)常用于治疗关节软骨的症状性缺陷。

目的

测试基质相关的自体软骨细胞移植或原始骨膜瓣技术在临床疗效和安全性方面是否具有优势。

研究设计

随机对照试验;证据水平,2 级。

方法

21 例(平均年龄 29.3±9.1 岁)患有股骨髁处有症状的全层软骨缺损(平均 4.1±0.9cm2)的患者被随机分为基质相关的自体软骨细胞移植或原始骨膜瓣技术组。主要结局参数是 ACI 后 12 个月时膝关节功能的术后变化,通过国际膝关节文献委员会(IKDC)评分评估。此外,还在术后 3、6、12 和 24 个月评估 IKDC 评分。次要结局参数是术后 3、6、12 和 24 个月的健康相关生活质量(SF-36 健康调查)、膝关节功能(Lysholm 和 Gillquist 评分)和身体活动(Tegner 活动评分)的变化。在 ACI 后 6、12 和 24 个月进行磁共振成像(MRI)以评估软骨,并使用磁共振观察软骨修复组织评分进行评估。记录不良事件以评估安全性。

结果

ACI 后 1 年,主要结局参数显示患者有改善,但骨膜瓣技术与基质相关 ACI 之间无差异(P=.5573);ACI 后 2 年,也得到了类似的结果(P=.4994)。研究组在 ACI 后 12 个月(P=.4063)和 24 个月(P=.1043)时,SF-36 各分类和 Tegner 活动评分的膝关节功能均无差异。在 ACI 后 12 个月(P=.0449)和 24 个月(P=.0487),Lysholm 和 Gillquist 评分有利于骨膜瓣技术组,差异有统计学意义。术后 6 个月,基质相关 ACI 组的磁共振观察软骨修复评分明显较低(P=.0123),对应的磁共振成像诊断结果更正常。在 ACI 后 12 个月和 24 个月,两组之间的差异无统计学意义(12 个月,P=.2065;24 个月,P=.6926)。不良事件与膝关节问题有关,如移植物分层、骨赘形成、骨软骨分离和移植物肥大。未发生全身性(过敏、中毒或自身免疫)反应。

结论

ACI 后 12 个月和 24 个月时,在国际膝关节文献委员会、Tegner 活动评分和 SF-36 方面,原始和先进的 ACI 技术之间的疗效无差异;然而,在 Lysholm 和 Gillquist 评分方面,骨膜瓣技术组的疗效更好。

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