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基于水凝胶的基质相关自体软骨细胞移植在24个月随访时显示出比微骨折更大的实质性临床益处:一项倾向评分匹配对分析。

Hydrogel-Based Matrix-Associated Autologous Chondrocyte Implantation Shows Greater Substantial Clinical Benefit at 24 Months Follow-Up than Microfracture: A Propensity Score Matched-Pair Analysis.

作者信息

Gaissmaier Christoph, Angele Peter, Spiro Robert C, Köhler Annette, Kirner Alexandra, Niemeyer Philipp

机构信息

TETEC-Tissue Engineering Technologies AG, Reutlingen, Germany.

Sporthopaedicum Regensburg, Regensburg, Germany.

出版信息

Cartilage. 2025 Jun;16(2):139-149. doi: 10.1177/19476035241235928. Epub 2024 Mar 19.

Abstract

ObjectiveTo compare substantial clinical benefit (SCB) of a hydrogel-based, matrix-associated autologous chondrocyte implantation (M-ACI) method versus microfracture (MFx) in the treatment of knee cartilage defects.DesignPropensity score matched-pair analysis, using the MFx control group of a phase III study as comparator for M-ACI treatment in a single-arm phase III study, resulting in 144 patients in the matched-pair set.ResultsGroups were comparable regarding baseline Knee Injury and Osteoarthritis Outcome Score (KOOS), sex, age, body mass index, symptom duration, smoking status, and previous knee surgeries. Defect sizes in the M-ACI group were significantly larger than in the MFx group (6.4 cm vs. 3.7 cm). Other differences concerned location, number, and etiology of defects that were not considered to influence the interpretation of results. At 24 months, significantly more patients in the M-ACI group achieved SCB in KOOS pain (72.2% vs. 48.6%; = 0.0108), symptoms (84.7% vs. 61.1%, = 0.0039), sports/recreation (84.7% vs. 56.9%, = 0.0008), and quality of life (QoL; 72.2% vs. 44.4%, = 0.0014). The SCBs for KOOS activities in daily living and International Knee Documentation Committee score were higher for M-ACI but not significantly different from MFx. The SCB rates consistently favored M-ACI from 3 months onward. The highest improvements from baseline at 24 months in patients with SCB were observed for KOOS sports/rec. (M-ACI: 60.8 points, MFx: 55.9 points) and QoL (M-ACI: 58.1, MFx: 57.4).ConclusionHydrogel-based M-ACI demonstrated superior SCB in KOOS pain, symptoms, sports/rec., and QoL compared with MFx in patients with knee cartilage defects through 2 years follow-up.

摘要

目的

比较基于水凝胶的基质相关自体软骨细胞植入术(M-ACI)与微骨折术(MFx)治疗膝关节软骨缺损的实质性临床获益(SCB)。

设计

倾向评分匹配对分析,将一项III期研究的MFx对照组作为单臂III期研究中M-ACI治疗的对照,最终匹配对集中有144例患者。

结果

两组在基线膝关节损伤和骨关节炎疗效评分(KOOS)、性别、年龄、体重指数、症状持续时间、吸烟状况及既往膝关节手术方面具有可比性。M-ACI组的缺损尺寸显著大于MFx组(6.4平方厘米对3.7平方厘米)。其他差异涉及缺损的位置、数量和病因,这些不被认为会影响结果的解读。在24个月时,M-ACI组在KOOS疼痛(72.2%对48.6%;P = 0.0108)、症状(84.7%对61.1%,P = 0.0039)、运动/娱乐(84.7%对56.9%,P = 0.0008)和生活质量(QoL;72.2%对44.4%,P = 0.0014)方面实现SCB的患者明显更多。M-ACI组在KOOS日常生活活动方面的SCB以及国际膝关节文献委员会评分更高,但与MFx组无显著差异。从3个月起,SCB率一直有利于M-ACI。在24个月时,实现SCB的患者中,KOOS运动/娱乐(M-ACI组:60.8分,MFx组:55.9分)和QoL(M-ACI组:58.1分,MFx组:57.4分)从基线的改善最为明显。

结论

通过2年随访,与MFx相比,基于水凝胶的M-ACI在膝关节软骨缺损患者的KOOS疼痛、症状、运动/娱乐和QoL方面表现出更优的SCB。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/8e3b/12066853/fb2682c92833/10.1177_19476035241235928-fig1.jpg

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