Christoph Gaissmaier, Peter Angele, Robert C Spiro, Annette Köhler, Alexandra Kirner, Philipp Niemeyer
{"title":"基于水凝胶的基质相关自体软骨细胞植入术在 24 个月随访时比微骨折术显示出更大的实质性临床获益:倾向得分配对分析》。","authors":"Christoph Gaissmaier, Peter Angele, Robert C Spiro, Annette Köhler, Alexandra Kirner, Philipp Niemeyer","doi":"10.1177/19476035241235928","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To 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.</p><p><strong>Design: </strong>Propensity 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.</p><p><strong>Results: </strong>Groups 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<sup>2</sup> vs. 3.7 cm<sup>2</sup>). 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%; <i>P</i> = 0.0108), symptoms (84.7% vs. 61.1%, <i>P</i> = 0.0039), sports/recreation (84.7% vs. 56.9%, <i>P</i> = 0.0008), and quality of life (QoL; 72.2% vs. 44.4%, <i>P</i> = 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).</p><p><strong>Conclusion: </strong>Hydrogel-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.</p>","PeriodicalId":9626,"journal":{"name":"CARTILAGE","volume":" ","pages":"19476035241235928"},"PeriodicalIF":2.7000,"publicationDate":"2024-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11569661/pdf/","citationCount":"0","resultStr":"{\"title\":\"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.\",\"authors\":\"Christoph Gaissmaier, Peter Angele, Robert C Spiro, Annette Köhler, Alexandra Kirner, Philipp Niemeyer\",\"doi\":\"10.1177/19476035241235928\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To 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.</p><p><strong>Design: </strong>Propensity 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.</p><p><strong>Results: </strong>Groups 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<sup>2</sup> vs. 3.7 cm<sup>2</sup>). 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%; <i>P</i> = 0.0108), symptoms (84.7% vs. 61.1%, <i>P</i> = 0.0039), sports/recreation (84.7% vs. 56.9%, <i>P</i> = 0.0008), and quality of life (QoL; 72.2% vs. 44.4%, <i>P</i> = 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. 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引用次数: 0
摘要
目的比较水凝胶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):倾向得分配对分析:在一项单臂 III 期研究中,将一项 III 期研究的 MFx 对照组作为 M-ACI 治疗的比较组,结果配对组中有 144 名患者:各组在基线膝关节损伤和骨关节炎结果评分(KOOS)、性别、年龄、体重指数、症状持续时间、吸烟状况和既往膝关节手术方面具有可比性。M-ACI 组的缺损面积明显大于 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,但不影响对结果的解释。24 个月后,M-ACI 组患者在 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)方面获得 SCB 的人数明显增多。M-ACI 在 KOOS 日常活动量和国际膝关节文献委员会评分方面的 SCB 值更高,但与 MFx 没有显著差异。从3个月起,SCB率一直倾向于M-ACI。在 24 个月时,SCB 患者的 KOOS 运动/休闲(M-ACI:60.8 分,MFx:55.9 分)和 QoL(M-ACI:58.1 分,MFx:57.4 分)与基线相比改善幅度最大:水凝胶基 M-ACI 在膝关节软骨缺损患者的 KOOS 疼痛、症状、运动/休闲和 QoL 方面的 SCB 优于 MFx(随访 2 年)。
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.
Objective: To 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.
Design: Propensity 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.
Results: Groups 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 cm2 vs. 3.7 cm2). 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%; P = 0.0108), symptoms (84.7% vs. 61.1%, P = 0.0039), sports/recreation (84.7% vs. 56.9%, P = 0.0008), and quality of life (QoL; 72.2% vs. 44.4%, P = 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).
Conclusion: Hydrogel-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.
期刊介绍:
CARTILAGE publishes articles related to the musculoskeletal system with particular attention to cartilage repair, development, function, degeneration, transplantation, and rehabilitation. The journal is a forum for the exchange of ideas for the many types of researchers and clinicians involved in cartilage biology and repair. A primary objective of CARTILAGE is to foster the cross-fertilization of the findings between clinical and basic sciences throughout the various disciplines involved in cartilage repair.
The journal publishes full length original manuscripts on all types of cartilage including articular, nasal, auricular, tracheal/bronchial, and intervertebral disc fibrocartilage. Manuscripts on clinical and laboratory research are welcome. Review articles, editorials, and letters are also encouraged. The ICRS envisages CARTILAGE as a forum for the exchange of knowledge among clinicians, scientists, patients, and researchers.
The International Cartilage Repair Society (ICRS) is dedicated to promotion, encouragement, and distribution of fundamental and applied research of cartilage in order to permit a better knowledge of function and dysfunction of articular cartilage and its repair.