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与微骨折术相比,基质相关软骨细胞植入术的再次手术率更低:一项针对膝关节软骨缺损的具有人群代表性的配对索赔数据分析结果

Matrix-Associated Chondrocyte Implantation Is Associated With Fewer Reoperations Than Microfracture: Results of a Population-Representative, Matched-Pair Claims Data Analysis for Cartilage Defects of the Knee.

作者信息

Niemeyer Philipp, Schubert Tino, Grebe Marco, Hoburg Arnd

机构信息

Department of Orthopedics and Trauma Surgery, University Medical Center Freiburg, Albert Ludwig University of Freiburg, Freiburg, Germany.

OCM Orthopädische Chirurgie München, Munich, Germany.

出版信息

Orthop J Sports Med. 2019 Oct 21;7(10):2325967119877847. doi: 10.1177/2325967119877847. eCollection 2019 Oct.

Abstract

BACKGROUND

Symptomatic cartilage defects of the knee are commonly surgically treated by microfracture (MFX) or matrix-associated chondrocyte implantation (M-ACI). Several randomized controlled trials have compared MFX and M-ACI, showing a tendency to lower reoperation rates for M-ACI, but results vary widely between studies.

PURPOSE

To compare reoperation rates after MFX and M-ACI in cartilage defects of the knee outside clinical trials in a representative sample of the population.

STUDY DESIGN

Cohort study; Level of evidence, 3.

METHODS

This study was based on anonymized, population-representative claims data of 4 million insured persons in Germany. Patients who underwent MFX or M-ACI for cartilage defects of the knee with a follow-up of 2 years were compared. The primary endpoint was the need for a reoperation, defined as a claim for a second surgical procedure from the same patient at the knee joint (27 procedure codes), meniscus and cartilage (35 procedure codes), or patella (102 procedure codes) or the need for knee replacement (11 procedure codes). Group comparisons were performed using log-rank tests, with a 2-sided value of <.05 to indicate significance. For adjusted analysis, propensity score matching was applied. Age, sex, comedications, and comorbidities were used as matching parameters.

RESULTS

A total of 6425 patients fulfilled the inclusion criteria: 6273 treated with MFX and 152 treated with M-ACI (mean age, 53 and 36 years, respectively). In the 2 years after treatment, 1271 patients in the MFX group needed a reoperation compared with 19 in the M-ACI group (20.3% vs 12.5%, respectively; = .0199). For adjusted analysis after propensity score matching, 127 patients per group were analyzed. Their mean age was 37 years. At the end of the second follow-up year, 28 and 16 patients needed reoperations in the MFX and M-ACI groups, respectively (22.0% vs 12.6%, respectively; = .0498).

CONCLUSION

This study used a representative sample of the population and a broad definition of a reoperation, thus expanding evidence from clinical trials. We found a significant advantage of M-ACI in reoperation rates 2 years after treatment. After adjusting for age, sex, comedications, and comorbidities, M-ACI still showed significantly lower reoperation rates after 2 years.

摘要

背景

有症状的膝关节软骨缺损通常采用微骨折术(MFX)或基质相关软骨细胞植入术(M-ACI)进行手术治疗。多项随机对照试验比较了MFX和M-ACI,结果显示M-ACI的再次手术率有降低趋势,但不同研究结果差异很大。

目的

在具有代表性的人群样本中,比较MFX和M-ACI治疗膝关节软骨缺损后在非临床试验中的再次手术率。

研究设计

队列研究;证据等级,3级。

方法

本研究基于德国400万参保人员的匿名、具有人群代表性的索赔数据。对因膝关节软骨缺损接受MFX或M-ACI治疗且随访2年的患者进行比较。主要终点是再次手术的必要性,定义为同一名患者膝关节(27个手术编码)、半月板和软骨(35个手术编码)或髌骨(102个手术编码)的第二次手术索赔,或膝关节置换的必要性(11个手术编码)。采用对数秩检验进行组间比较,双侧P值<0.05表示有显著性差异。对于校正分析,应用倾向评分匹配。年龄、性别、合并用药和合并症用作匹配参数。

结果

共有6425例患者符合纳入标准:6273例接受MFX治疗,152例接受M-ACI治疗(平均年龄分别为53岁和36岁)。治疗后的2年中,MFX组有1271例患者需要再次手术,而M-ACI组为19例(分别为20.3%和12.5%;P = 0.0199)。倾向评分匹配后的校正分析中,每组分析127例患者。他们的平均年龄为37岁。在第二次随访年末,MFX组和M-ACI组分别有28例和16例患者需要再次手术(分别为22.0%和12.6%;P = 0.0498)。

结论

本研究使用了具有代表性的人群样本和广泛的再次手术定义,从而扩展了临床试验的证据。我们发现M-ACI在治疗后2年的再次手术率方面具有显著优势。在校正年龄、性别、合并用药和合并症后,M-ACI在2年后仍显示出显著较低的再次手术率。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/47e5/6804358/f4fd8b377a60/10.1177_2325967119877847-fig1.jpg

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