High Failure Rate of a Decellularized Osteochondral Allograft for the Treatment of Cartilage Lesions
High Failure Rate of a Decellularized Osteochondral Allograft for the Treatment of Cartilage Lesions
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DOI：
10.1177/0363546516645086
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发表时间：
2016-08-01
影响因子：
4.8
通讯作者：
Gomoll, Andreas H.
中科院分区：
文献类型：
--
作者：
Farr, Jack;Gracitelli, Guilherme C.;Gomoll, Andreas H.
背景：新鲜同种异体移植的广泛采用仍然有限，主要是由于供应问题。为了克服这些局限性，一种预成型的圆柱形灭菌脱细胞骨软骨同种异体移植物（SDOCA）植入物最近被引入作为临床治疗选择。目的：评价使用SDOCA植入物治疗膝关节软骨损伤患者的功能结局和移植物存活率。研究设计：病例系列;证据等级：4.方法：使用机构审查委员会批准的数据库识别一系列前瞻性收集数据的患者，这些患者接受了SDOCA植入物治疗。手术由2名外科医生在2个中心进行。评估患者报告的结局、磁共振成像（MRI）以及再次手术的数量和类型。失败定义为关节镜或MRI诊断的移植物结构损伤，以及导致同种异体移植物取出的任何再次手术。使用膝关节损伤和骨关节炎结局评分（KOOS）和马克思运动活动量表对患者进行术前和术后评价。MRI术前和术后进行了评估。结果：有32例患者的平均年龄（SD）为35.1 +/- 10.6岁，59%为男性。23例（72%）膝关节既往接受过手术。平均缺损面积（+/- SD）为2.9 +/- 2.0 cm（2），平均同种异体移植物尺寸为13.18 +/- 2.3 mm（6个移植物9 mm，59个移植物11 mm）。每个膝关节的同种异体移植物中位数为2（范围，1-5个移植物）。根据上述定义，32例膝关节中的23例（72%）被视为失效。其中，14例膝关节（43%）在首次手术后接受了进一步手术。2年时植入物存活率为19.6%。平均随访时间为1.29年（范围：0.11-2.8年）。KOOS疼痛、日常生活活动（ADL）、运动和娱乐（运动/娱乐）以及膝关节相关生活质量从术前访视至最近随访显著改善。年龄是失败的显著预测因素，风险比为1.68/1 SD（95% CI，1.05-2.68; P = 0.030）。MOCART（软骨修复组织的磁共振观察）特征积液是与KOOS（症状、疼痛、ADL、运动/运动）相关的唯一评分。结论：在这2个机构，SDOCA植入物在植入的前2年内失败率为72%。
Background: Widespread adoption of fresh allograft transplantation remains limited, predominantly by supply issues. To overcome these limitations, a preshaped, cylindrical sterilized and decellularized osteochondral allograft (SDOCA) implant was recently introduced as a clinical treatment option.Purpose: To evaluate functional outcomes and graft survivorship among patients treated with the SDOCA implant for knee cartilage injuries.Study Design: Case series; Level of evidence, 4.Methods: An institutional review board-approved database was used to identify a series of patients with prospectively collected data who had been treated with the SDOCA implant. The surgeries were performed at 2 centers by 2 surgeons. Patient-reported outcomes, magnetic resonance imaging (MRI), and the number and type of reoperations were assessed. Failure was defined as structural damage of the graft diagnosed by arthroscopy or MRI, and any reoperation resulting in removal of the allograft. Patients were evaluated pre- and postoperatively using the Knee injury and Osteoarthritis Outcome Score (KOOS) and Marx Sports Activity Scale. MRI was assessed preoperatively and postoperatively.Results: There were 32 patients with a mean age (SD) of 35.1 +/- 10.6 years; 59% were male. Twenty-three (72%) knees had previous surgery. The mean defect area (+/- SD) was 2.9 +/- 2.0 cm(2), and the mean allograft size was 13.18 +/- 2.3 mm (6 grafts 9 mm and 59 grafts 11 mm). The median number of allografts per knee was 2 (range, 1-5 grafts). Twenty-three of the 32 knees (72%) were considered failures by the definition detailed above. Of these, 14 knees (43%) had further surgery after the index procedure. Implant survivorship was 19.6% at 2 years. The mean follow-up duration was 1.29 years (range, 0.11-2.8 years). KOOS pain, activities of daily living (ADL), sports and recreation (sport/rec), and knee-related quality of life improved significantly from the preoperative visit to latest follow-up. Age was significantly predictive of failure, with a hazard ratio of 1.68 per 1 SD older (95% CI, 1.05-2.68; P = .030). The MOCART (magnetic resonance observation of cartilage repair tissue) feature effusion was the only score to correlate with KOOS (symptoms, pain, ADL, sport/rec).Conclusion: The SDOCA implant demonstrated a 72% failure rate within the first 2 years of implantation at these 2 institutions.