Aims Knee osteoarthritis (OA) is characterized by a chronic inflammatory process involving multiple cytokine pathways, leading to articular cartilage degeneration. Intra-articular therapies using pharmaceutical or autologous anti-inflammatory factors offer potential non-surgical treatment options. Autologous protein solution (APS) is one such product that uses the patient's blood to produce a concentrate of cells and anti-inflammatory cytokines. This study evaluated the effect of a specific APS intra-articular injection (nSTRIDE) on patient-reported outcome measures compared to saline in moderate knee OA. Methods A parallel, double-blinded, placebo-controlled randomized controlled trial was conducted, where patients with unilateral moderate knee OA (Kellgren-Lawrence grade 2 or 3) received either nSTRIDE or saline (placebo) injection to their symptomatic knee. The primary outcome was the difference in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 12 months post-intervention. Secondary outcomes included WOMAC component scores, Knee injury and Osteoarthritis Outcome Score (KOOS), and visual analogue scale (VAS) scores at all follow-up timepoints (three, six, and 12 months). Results A total of 40 patients were analyzed (21 nSTRIDE; 19 saline) in the study. No significant difference was found between nSTRIDE and saline groups for WOMAC total score at 12 months (mean difference -10.4 (95% CI -24.4 to 3.6; p = 0.141). There were no significant differences in WOMAC or KOOS scores across all timepoints. VAS scores favoured the saline group for both rest and worst pain scales at 12 months post-injection (mean difference (worst) 12 months 21.5 (95% CI 6.2 to 36.8; p = 0.008); mean difference (rest) 12 months 17.8 (95% CI 2.2 to 33.4; p = 0.026)). There were no adverse events recorded in either study group. Conclusion Our study demonstrates no significant differences between nSTRIDE and saline groups in KOOS and WOMAC scores over time. Notably, APS injection resulted in significantly worse pain symptoms at 12 months compared to saline injection.

中文翻译：

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关节内自体蛋白溶液对膝骨关节炎症状的影响。


目的 膝骨关节炎 (OA) 的特点是涉及多种细胞因子途径的慢性炎症过程，导致关节软骨退化。使用药物或自体抗炎因子的关节内治疗提供了潜在的非手术治疗选择。自体蛋白溶液（APS）就是这样一种产品，它利用患者的血液来产生细胞浓缩物和抗炎细胞因子。本研究评估了中度膝关节骨关节炎中特定 APS 关节内注射 (nSTRIDE) 与生理盐水相比对患者报告的结果测量的影响。方法进行了一项平行、双盲、安慰剂对照的随机对照试验，其中单侧中度膝关节 OA（Kellgren-Lawrence 2 级或 3 级）患者在有症状的膝关节注射 nSTRIDE 或生理盐水（安慰剂）。主要结果是干预后 12 个月时西安大略大学和麦克马斯特大学骨关节炎指数 (WOMAC) 总分的差异。次要结局包括 WOMAC 成分评分、膝关节损伤和骨关节炎结果评分 (KOOS) 以及所有随访时间点（3、6 和 12 个月）的视觉模拟量表 (VAS) 评分。结果 该研究共分析了 40 名患者（21 名 nSTRIDE；19 名生理盐水）。 12 个月时，nSTRIDE 组和盐水组之间的 WOMAC 总评分没有显着差异（平均差 -10.4（95% CI -24.4 至 3.6；p = 0.141）。所有时间点的 WOMAC 或 KOOS 评分没有显着差异。注射后 12 个月时，VAS 评分在休息和最严重疼痛量表方面均优于盐水组（平均差（最差）12 个月 21.5（95% CI 6.2 至 36.8；p = 0.008）；平均差（休息）12 个月 17.8（ 95% CI 2.2 至 33.4；p = 0。026））。两个研究组均未记录不良事件。结论 我们的研究表明，随着时间的推移，nSTRIDE 组和盐水组之间的 KOOS 和 WOMAC 评分没有显着差异。值得注意的是，与注射生理盐水相比，注射 APS 在 12 个月时导致疼痛症状明显更严重。