Background:The effectiveness and safety of matrix-associated autologous chondrocyte implantation with an autologous periosteal flap (pMACI) remain unclear. The Japanese Ministry of Health, Labor, and Welfare requires postmarketing surveillance of all patients undergoing pMACI using the tissue-engineered product JACC.Purpose:To evaluate the effectiveness and safety of pMACI for large articular cartilage defects (≥4 cm2) in the knee joint using real-world data analysis.Study Design:Case series; Level of evidence, 4.Methods:Data were collected from patients who underwent pMACI between 2012 and 2019, with 2 years of follow-up. The primary outcomes were the Lysholm knee score and Knee injury and Osteoarthritis Outcome Score (KOOS) at 6, 12, and 24 months. Adverse events were assessed by physical examination, magnetic resonance imaging, and/or arthroscopy.Results:Overall, 232 knees in 225 patients who presented with trauma (198 knees) or osteochondritis dissecans (34 knees) in the medial (132 knees) and lateral (44 knees) femoral condyle, patella (25 knees), trochlea (86 knees), and tibial plateau (4 knees) were included. The mean age of the patients was 40.9 ± 15.0 years, with mean cartilage defects of 5.6 ± 2.4 cm2 in size. Concomitant surgeries, such as osteotomy (50 knees), ligament reconstruction (27 knees), meniscal procedures (28 knees), osteochondral autograft transplantation (24 knees), and microfracture (14 knees), were performed in 113 (48.7%) knees. The minimal clinically important difference in the Lysholm knee score and KOOS Symptoms subscale was achieved in 79.7% and 63.5% of patients, respectively, and the Patient Acceptable Symptom State was achieved in 90.1% and 73.7%, respectively. Substantial clinical benefit was achieved in the KOOS Sports/Recreation and Quality of Life subscales at 39.6% and 37.8%, respectively. Knees that underwent concomitant microfracture had significantly worse KOOS values than the remainder of the cohort. Complications, including effusion (16.8%), graft delamination (14.7%), knee contracture (9.1%), graft hypertrophy (8.2%), and ossification (3.4%), were observed in 86 (37.1%) knees. Osteochondritis dissecans was significantly associated with graft hypertrophy and ossification, whereas concomitant surgery was significantly associated with delamination and contracture. Treatment failure required additional cartilage procedures in 11 (4.7%) knees.Conclusion:Treatment of large cartilage defects (≥4 cm2) with pMACI resulted in improved outcome scores in approximately 75% of patients. However, complications occurred in one-third of patients, and 4.7% required reoperation.

中文翻译：

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基质相关自体软骨细胞植入治疗关节软骨缺损的有效性和安全性：日本的真实世界数据分析


背景： 基质相关自体软骨细胞植入自体骨膜瓣 （pMACI） 的有效性和安全性尚不清楚。日本厚生劳动省要求对所有使用组织工程产品 JACC 接受 pMACI 的患者进行上市后监测。目的： 使用真实世界数据分析评估 pMACI 治疗膝关节大关节软骨缺损 （≥4 cm2） 的有效性和安全性。研究设计： 病例系列;证据水平， 4.方法： 从 2012 和 2019年接受 pMACI 的患者收集数据，随访 2 年。主要结局是 6 、 12 和 24 个月的 Lysholm 膝关节评分和膝关节损伤和骨关节炎结果评分 （KOOS）。通过体格检查、磁共振成像和/或关节镜检查评估不良事件。结果： 总体而言，包括内侧 （132 个膝） 和外侧 （44 个膝） 股骨髁、髌骨 （25 个膝） 、滑车 （86 个膝） 和胫骨平台（4 个膝）外伤 （198 个膝） 或剥脱性骨软骨炎 （34 个膝） 患者的 232 个膝关节。患者的平均年龄为 40.9 ± 15.0 岁，平均软骨缺损大小为 5.6 ± 2.4 cm2。113 例 （48.7%） 膝关节进行了伴随手术，如截骨术 （50 例膝关节）、韧带重建 （27 例膝关节）、半月板手术 （28 例膝关节）、骨软骨自体移植术 （24 例膝关节） 和微骨折 （14 例膝关节）。Lysholm 膝关节评分和 KOOS 症状分量表的临床重要差异分别为 79.7% 和 63.5%，患者可接受的症状状态分别为 90.1% 和 73.7%。 KOOS 运动/娱乐和生活质量分量表分别达到 39.6% 和 37.8%，取得了实质性的临床益处。伴随微骨折的膝关节的 KOOS 值明显低于队列中的其他膝关节。在 86 例 （37.1%） 膝关节中观察到并发症，包括积液 （16.8%）、移植物分层 （14.7%）、膝关节挛缩 （9.1%）、移植物肥大 （8.2%） 和骨化 （3.4%）。剥脱性骨软骨炎与移植物肥大和骨化显著相关，而伴随手术与分层和挛缩显著相关。治疗失败需要在 11 个 （4.7%） 膝关节进行额外的软骨手术。结论： pMACI 治疗大软骨缺损 （≥4 cm2） 导致约 75% 的患者结局评分改善。然而，1/3 的患者出现并发症，4.7% 的患者需要再次手术。