Outcomes After a Single-Stage Procedure for Cell-Based Cartilage Repair A Prospective Clinical Safety Trial With 2-year Follow-up
Outcomes After a Single-Stage Procedure for Cell-Based Cartilage Repair A Prospective Clinical Safety Trial With 2-year Follow-up
复制标题
DOI：
10.1177/0363546511399382
复制
发表时间：
2011-06-01
影响因子：
4.8
通讯作者：
De Deyne, Patrick G.
中科院分区：
文献类型：
--
作者：
Cole, Brian J.;Farr, Jack;De Deyne, Patrick G.
背景资料：目前有几种治疗关节软骨局灶性缺损的方法，每种方法都有特定的优点或挑战。一个单阶段的程序，使用自体软骨碎片，软骨自体移植植入系统（CAIS），正在评估的患者，并可能提供一个临床有效的选择。目的：建立安全的CAIS和测试是否CAIS改善生活质量通过使用标准化的结果评估工具。研究设计：随机对照试验;证据等级，2。方法：患者（n = 29）随机（1：2）接受对照（微骨折[MFX]）或实验（CAIS）手术治疗。使用几种标准化结局评估工具（SF-36、国际膝关节文献委员会[IKDC]、膝关节损伤和骨关节炎结局评分[KOOS]），在预定时间点对患者进行为期2年的随访。在基线、3周、6、12和24个月时进行磁共振成像。结果：两组的病变大小和国际腕关节修复学会（ICRS）分级相似。一般结局指标（例如，SF-36的身体成分评分）表明两组总体改善，CAIS组和MFX组之间的不良反应数量无差异。CAIS组的IKDC评分（12个月时为73.9 ± 14.72，24个月时为82.95 ± 14.88）显著高于MFX组（12个月时为57.78 ± 18.31，24个月时为59.5 ± 13.44）。KOOS工具中的选定子域（4/5）在12个月和18个月时存在显著差异，所有子域在CAIS中，24个月时症状和僵硬、疼痛、日常生活活动、运动和娱乐、膝关节相关生活质量显著增加，评分为88.47 +/- 11.68，90.64 +/- 7.87，97.29 ± 3.8、78.16 ± 22.06和69 ± 23.15，而MFX组为75 ± 9.31、78.94 ± 13.73、89.46 ± 8.13、51.67 ± 26.01和37.15 ± 21.67。在IKDC和KOOS，这些显著改善都维持在24个月。影像学数据的定性分析未发现两组在移植床填充、组织整合或软骨下囊肿存在方面存在差异。接受MFX治疗的患者病灶内骨赘形成的发生率显著较高与CAIS相比，第6个月和第12个月时（占治疗病变总数的54%和70%）（占治疗病变总数的8%和25%）。CAIS治疗局灶性软骨缺损的首次临床经验表明，有效的方法，可以改善长期的临床结果。
Background: There are currently several approaches being pursued to treat focal defects of articular cartilage, each having specific advantages or challenges. A single-stage procedure that uses autologous cartilage fragments, Cartilage Autograft Implantation System (CAIS), is being evaluated in patients and may offer a clinically effective option.Purpose: To establish the safety of CAIS and to test whether CAIS improves quality of life by using standardized outcomes assessment tools.Study Design: Randomized controlled trial; Level of evidence, 2.Methods: Patients (n = 29) were randomized (1: 2) with the intent to treat with either a control (microfracture [MFX]) or an experimental (CAIS) procedure. Patients were followed at predetermined time points for 2 years using several standardized outcomes assessment tools (SF-36, International Knee Documentation Committee [IKDC], Knee injury and Osteoarthritis Outcome Score [KOOS]). Magnetic resonance imaging was performed at baseline, 3 weeks, and 6, 12, and 24 months.Results: Lesion size and International Cartilage Repair Society (ICRS) grade were similar in both groups. General outcome measures (eg, physical component score of the SF-36) indicated an overall improvement in both groups, and no differences in the number of adverse effects were noted in comparisons between the CAIS and MFX groups. The IKDC score of the CAIS group was significantly higher (73.9 +/- 14.72 at 12 months and 82.95 +/- 14.88 at 24 months) compared with the MFX group (57.78 +/- 18.31 at 12 months and 59.5 +/- 13.44 at 24 months). Select subdomains (4/5) in the KOOS instrument were significantly different at 12 and 18 months, and all subdomains (Symptoms and Stiffness, Pain, Activities of Daily Living, Sports and Recreation, Knee-related Quality of Life) were significantly increased at 24 months in CAIS with scores of 88.47 +/- 11.68, 90.64 +/- 7.87, 97.29 +/- 3.8, 78.16 +/- 22.06, and 69 +/- 23.15 compared with 75 +/- 9.31, 78.94 +/- 13.73, 89.46 +/- 8.13, 51.67 +/- 26.01, and 37.15 +/- 21.67 in the MFX group. These significant improvements were maintained at 24 months in both IKDC and KOOS. Qualitative analysis of the imaging data did not note differences between the 2 groups in fill of the graft bed, tissue integration, or presence of subchondral cysts. Patients treated with MFX had a significantly higher incidence of intralesional osteophyte formation (54% and 70% of total number of lesions treated) at 6 and 12 months when compared with CAIS (8% and 25% of total number of lesions treated).Conclusion: The first clinical experience in using CAIS for treating patients with focal chondral defects indicates that it is a safe, feasible, and effective method that may improve long-term clinical outcomes.