Ernits Kaarel, Märtson Aare, Kals Jaak, Tagoma Aili, Maasalu Katre, Aus Anneli, Vent Kristi, Tootsi Kaspar
Department of Orthopaedics, Institute of Clinical Medicine, University of Tartu, Tartu, Estonia
Endothelial Centre, University of Tartu, Tartu, Estonia.
BMJ Open. 2025 Jun 23;15(6):e096433. doi: 10.1136/bmjopen-2024-096433.
Total hip arthroplasty (THA) is an effective treatment for severe osteoarthritis. However, THA has a high surgical risk for patients with concomitant diseases and is associated with several serious complications, such as myocardial infarction, acute kidney injury and cognitive dysfunction. This study will explore the potential protective effects of remote ischaemic preconditioning (RIPC) in cemented THA patients.
The PRINCIPAL study is designed as a randomised, controlled, parallel-group, blinded trial to assess the impact of RIPC in cemented THA patients. The study will compare two patient groups-one group will have the RIPC procedure, and the second will have the sham procedure. The primary outcome is the peak troponin T concentration during the three postoperative days. Secondary outcomes include markers of arterial stiffness (augmentation index (AIx), carotid-femoral pulse wave velocity, central blood pressures), neural (neuron-specific enolase, S100B) and renal injury biomarkers (estimated glomerular filtration rate, creatinine, cystatin C), markers of systemic inflammation (hypoxia-inducible factor 1-alpha, interleukin (IL)-6, IL-1β, tumour necrosis factor-alpha, IL-10) and oxidative stress (total peroxide concentration, total antioxidant capacity), as well as clinical outcome measures such as major adverse cardiovascular events and all-cause mortality.
The ethical board of the University of Tartu has granted approval for the study (no. 384T-26). The results of this study will be disseminated in international peer-reviewed journals.
NCT06323018.
全髋关节置换术（THA）是治疗重度骨关节炎的有效方法。然而，对于伴有其他疾病的患者，THA手术风险较高，且与多种严重并发症相关，如心肌梗死、急性肾损伤和认知功能障碍。本研究将探讨远程缺血预处理（RIPC）对骨水泥型THA患者的潜在保护作用。
PRINCIPAL研究设计为一项随机、对照、平行组、双盲试验，以评估RIPC对骨水泥型THA患者的影响。该研究将比较两组患者，一组接受RIPC操作，另一组接受假操作。主要结局是术后三天内肌钙蛋白T的峰值浓度。次要结局包括动脉僵硬度标志物（增强指数（AIx）、颈股脉搏波速度、中心血压）、神经损伤标志物（神经元特异性烯醇化酶、S100B）和肾损伤生物标志物（估计肾小球滤过率、肌酐、胱抑素C）、全身炎症标志物（缺氧诱导因子1-α、白细胞介素（IL）-6、IL-1β、肿瘤坏死因子-α、IL-10）和氧化应激标志物（总过氧化物浓度、总抗氧化能力），以及主要不良心血管事件和全因死亡率等临床结局指标。
塔尔图大学伦理委员会已批准该研究（编号384T-26）。本研究结果将在国际同行评审期刊上发表。
NCT06323018
