Kuala Lumpur Sports Medicine Centre, Kuala Lumpur, Malaysia.
Andrews Institute, Gulf Breeze, Florida, U.S.A.
Arthroscopy. 2021 Aug;37(8):2502-2517. doi: 10.1016/j.arthro.2021.01.067. Epub 2021 Jul 12.
The purpose of this study was to evaluate the safety and efficacy of intra-articular injections of autologous peripheral blood stem cells (PBSCs) plus hyaluronic acid (HA) after arthroscopic subchondral drilling into massive chondral defects of the knee joint and to determine whether PBSC therapy can improve functional outcome and reduce pain of the knee joint better than HA plus physiotherapy.
This is a dual-center randomized controlled trial (RCT). Sixty-nine patients aged 18 to 55 years with International Cartilage Repair Society grade 3 and 4 chondral lesions (size ≥3 cm) of the knee joint were randomized equally into (1) a control group receiving intra-articular injections of HA plus physiotherapy and (2) an intervention group receiving arthroscopic subchondral drilling into chondral defects and postoperative intra-articular injections of PBSCs plus HA. The coprimary efficacy endpoints were subjective International Knee Documentation Committee (IKDC) and Knee Injury and Osteoarthritis Outcome Score (KOOS)-pain subdomain measured at month 24. The secondary efficacy endpoints included all other KOOS subdomains, Numeric Rating Scale (NRS), and Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores.
At 24 months, the mean IKDC scores for the control and intervention groups were 48.1 and 65.6, respectively (P < .0001). The mean for KOOS-pain subdomain scores were 59.0 (control) and 86.0 (intervention) with P < .0001. All other KOOS subdomain, NRS, and MOCART scores were statistically significant (P < .0001) at month 24. Moreover, for the intervention group, 70.8% of patients had IKDC and KOOS-pain subdomain scores exceeding the minimal clinically important difference values, indicating clinical significance. There were no notable adverse events that were unexpected and related to the study drug or procedures.
Arthroscopic marrow stimulation with subchondral drilling into massive chondral defects of the knee joint followed by postoperative intra-articular injections of autologous PBSCs plus HA is safe and showed a significant improvement of clinical and radiologic scores compared with HA plus physiotherapy.
Level I, RCT.
本研究旨在评估关节镜下软骨下钻孔联合自体外周血干细胞（PBSC）与透明质酸（HA）关节内注射治疗膝关节大面积软骨缺损的安全性和有效性，并确定 PBSC 治疗是否比 HA 联合物理疗法更能改善膝关节的功能结局和减轻疼痛。
这是一项双中心随机对照试验（RCT）。将 69 名年龄在 18 至 55 岁之间的国际软骨修复学会（ICRS）3 级和 4 级软骨病变（大小≥3cm）的膝关节患者随机分为两组：（1）对照组接受关节内注射 HA 联合物理治疗；（2）干预组接受关节镜下软骨下钻孔治疗软骨缺损，并在术后关节内注射 PBSC 联合 HA。主要疗效终点是 24 个月时的主观国际膝关节文献委员会（IKDC）和膝关节损伤和骨关节炎结果评分（KOOS）-疼痛亚量表。次要疗效终点包括所有其他 KOOS 亚量表、数字评分量表（NRS）和磁共振软骨修复组织观察评分（MOCART）。
24 个月时，对照组和干预组的平均 IKDC 评分分别为 48.1 和 65.6（P＜0.0001）。KOOS 疼痛亚量表的平均评分分别为 59.0（对照组）和 86.0（干预组）（P＜0.0001）。所有其他 KOOS 亚量表、NRS 和 MOCART 评分在 24 个月时均具有统计学意义（P＜0.0001）。此外，干预组有 70.8%的患者 IKDC 和 KOOS 疼痛亚量表评分超过最小临床重要差异值，表明具有临床意义。没有出现与研究药物或程序相关的意外不良事件。
关节镜下软骨下钻孔联合膝关节大面积软骨缺损术后关节内注射自体 PBSC 联合 HA 是安全的，与 HA 联合物理治疗相比，临床和影像学评分有显著改善。
I 级，RCT。
