Fangzhou Chi, Mochizuki Tomoharu, Ushiki Takashi, Kawashima Hiroyuki
Division of Orthopedic Surgery, Niigata University Medical and Dental Hospital, Niigata, JPN.
Department of Transfusion Medicine, Cell Therapy and Regenerative Medicine, Niigata University Medical and Dental Hospital, Niigata, JPN.
Cureus. 2025 May 23;17(5):e84698. doi: 10.7759/cureus.84698. eCollection 2025 May.
This study aims to investigate the clinical outcomes and magnetic resonance imaging evaluation (MRI) of intra-articular injection of autologous protein solution (APS) in patients with knee osteoarthritis of varying severities.
A retrospective analysis was conducted on the clinical data of consecutive subjects with knee osteoarthritis (KOA) of varying Kellgren-Lawrence (KL) grades who underwent a single APS injection. The Knee injury and Osteoarthritis Outcome Score (KOOS), covering symptoms (S), pain (P), activity (A), sports (SP), and quality of life (Q), was used to evaluate the patients at pre-treatment and 12 months post-treatment. Minimal Clinically Important Difference (MCID) and Osteoarthritis Research Society International Set Responder Criteria Osteoarthritis Clinical Trials Revisited (OMERACT-OARSI) tools were used to observe improvement in different KL grades. Additionally, an MRI was performed pre-treatment and 12 months post-treatment. Semi-quantitative analysis (Magnetic Resonance Imaging Osteoarthritis Knee Score (MOAKS)) was applied to assess bone marrow lesions (BMLs), articular cartilage, osteophytes, synovitis and effusion, and meniscal lesions in various subregions of the knee joint.
A total of 53 patients (66 knees) were included in the final analysis. At 12 months post-treatment, overall KOOS scores showed improvement. The responder rates were 78.6% (11 knees) in KL2, 68.4% (13 knees) in KL3, and 51.5% (17 knees) in KL4. Significant improvements were observed in KOOS-S, KOOS-P, and KOOS-Q across all patients. KOOS-A and KOOS-SP demonstrated statistically significant differences only in the KL2 and KL4 groups (P < 0.05). Comparisons of KOOS score differences between groups revealed that patients in the KL2 group experienced greater improvements in activity levels and quality of life compared to those in the KL3 and KL4 groups (P < 0.05). MOAKS evaluation revealed no significant improvement in cartilage damage, BMLs, synovitis-effusion, and meniscal status. In the KL4 group, the post-treatment scores for patellar superior and inferior osteophytes were higher than the pre-treatment scores (P = 0.039).
This study provides evidence supporting the clinical efficacy of a single intra-articular injection of APS in KOA. However, the therapeutic effect of APS for structural changes in imaging remains limited.
本研究旨在调查关节腔内注射自体蛋白溶液（APS）对不同严重程度膝骨关节炎患者的临床疗效及磁共振成像评估（MRI）情况。
对连续接受单次APS注射的不同Kellgren-Lawrence（KL）分级的膝骨关节炎（KOA）患者的临床资料进行回顾性分析。采用涵盖症状（S）、疼痛（P）、活动度（A）、运动（SP）和生活质量（Q）的膝关节损伤和骨关节炎疗效评分（KOOS），在治疗前和治疗后12个月对患者进行评估。使用最小临床重要差异（MCID）和国际骨关节炎研究学会重新审视的骨关节炎临床试验应答标准（OMERACT-OARSI）工具，观察不同KL分级的改善情况。此外，在治疗前和治疗后12个月进行MRI检查。应用半定量分析（膝关节磁共振成像骨关节炎评分（MOAKS））评估膝关节各亚区域的骨髓病变（BMLs）、关节软骨、骨赘、滑膜炎和积液以及半月板损伤情况。
最终分析纳入53例患者（66个膝关节）。治疗后12个月，总体KOOS评分显示有所改善。KL2级的应答率为78.6%（11个膝关节），KL3级为68.4%（13个膝关节），KL4级为51.5%（17个膝关节）。所有患者的KOOS-S、KOOS-P和KOOS-Q均有显著改善。KOOS-A和KOOS-SP仅在KL2组和KL4组有统计学显著差异（P<0.05）。组间KOOS评分差异比较显示，KL2组患者在活动水平和生活质量方面的改善程度高于KL3组和KL4组患者（P<0.05）。MOAKS评估显示软骨损伤、BMLs、滑膜炎-积液和半月板状况无显著改善。在KL4组中，治疗后髌上和髌下骨赘评分高于治疗前评分（P=0.039）。
本研究提供了证据支持单次关节腔内注射APS对KOA的临床疗效。然而，APS对成像结构变化的治疗效果仍然有限。
