Predicting the Development of Bone Cement Implantation Syndrome in Arthroplasty Operations Using Artificial Intelligence Methods
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- collection of data-1
研究概览
简要总结
This study aims to predict the development of bone cement syndrome, which may develop due to polymethylmethacrylate cement used to adhere the prosthesis to the bone in arthroplasty surgeries, which may cause intraoperative and postoperative mortality and morbidity, using artificial intelligence methods and to provide a sustainable life comfort to patients in the postoperative period with the standardization predicted in the long term.
详细描述
Since the prevalence of hip and knee osteoarthritis increases with age, orthopedic prosthesis operations are widely performed all over the world and in our country. In these surgeries, bone cement is used to ensure adhesion of the prosthesis to the bone. Bone cement implantation syndrome (BCIS) is a fatal complication of cemented bone surgery characterized by systemic hypotension, pulmonary hypertension, arrhythmias, loss of consciousness and cardiac arrest, most commonly occurring during cementing and prosthesis placement, and is increasingly being reported.
The syndrome is most commonly seen in cemented hemiarthroplasty after displaced femoral neck fractures, but also occurs in total hip and knee replacement surgery. Despite the publication of safety guidelines to reduce BCIS, it remains a common intraoperative complication with an overall incidence of up to 28% and is a major cause of intraoperative and postoperative morbidity and mortality.
The pathophysiology of BCIS is unclear, including hemodynamic instability as a result of changes in pulmonary and systemic vascular resistance, increased intramedullary pressure resulting in the incorporation of polymethyl methacrylate monomers into the circulation causing vasodilation, release of mediators from polymethyl methacrylate, release of fatty acids, and release of mediators from polymethyl methacrylate, Acute right ventricular failure, anaphylaxis, inflammatory and exothermic reaction, and complement activation may include one or a combination of acute right ventricular failure, anaphylaxis, inflammatory and exothermic reaction, and complement activation, which develops when cement and clot particles cause emboli in many organs in the body, especially in the pulmonary system, with increased pulmonary vascular resistance. Donaldson et al. developed a classification system for BCIS severity. Grade 0: no hypotension/hypoxia; Grade 1 moderate hypoxia (SpO2 < 94%) or hypotension [systolic blood pressure (SBP) > 20% decrease from baseline]; Grade 2 severe hypoxia (SpO2 < 88%) or hypotension (SBP > 40% decrease from baseline) or unexpected loss of consciousness; Grade 3 cardiovascular collapse requiring cardiopulmonary resuscitation.
Patients with BCIS grades 2 and 3 have been shown to have a 16-fold increase in 30-day postoperative mortality compared to those with BCIS grade 1. Most reports on BCIS focus on deaths and serious problems, and most cases of mild BCIS go unreported. Suspected BCIS should be treated with aggressive resuscitation and supportive care.
This risk may prompt some surgeons not to use cement in arthroplasty operations. Although cementless hemiarthroplasty eliminates this risk and saves an average operating time of 20 minutes, it is associated with serious complications. Patients undergoing uncemented hip arthroplasty implants are more likely to experience periprosthetic fractures as well as early revision. Uncemented arthroplasty has a 17-fold greater risk of periprosthetic fracture revision or aseptic revision due to loosening compared to cemented hip arthroplasty. Since additional surgery carries an additional risk of death, skipping the cementation step may also not be the best choice in these patients who are more likely to fall and undergo revision surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Total knee arthrplasties
- •Partial hip arthrplasty using cement
- •Total hip arthrplasty using cement
- •Patients ≥18 years old.
排除标准
- •Patients who do not want to participate in the study
结局指标
主要结局
collection of data-1
时间窗: 2 months
General examination findings of the patient in the perioperative period, ASA score, whether the patient is female whether male or female, body mass index, age, whether mobility is decreased, whether assisted living, basic life parameters (operation blood pressure, pulse, respiratory rate, saturation, temperature, consciousness, orientation, etc.), the cause of the fracture (trauma, arthrosis, infection, necrosis, osteolysis, intertrochanteric fracture), type of surgery (total hip replacement, partial hip replacement, total knee replacement or revision surgery), medical history and medical history (cardiovascular disease, kidney disease, diabetes, stroke, peripheral vascular disease, arteriosclerosis, pulmonary hypertension, angina pectoris, congestive heart failure, COPD, cancer, dementia, arrhythmia, nicotine dependence, and the presence of previous myocardial infarction.
collection of data-2
时间窗: 2 months
β-adrenergic blockers, diuretics, antiplatelet drugs, organic nitrates, calcium antagonists, ACE inhibitors, ARBs, acetylsalicylic acid, insulin, and warfarin and statin use), radiological evaluations (chest radiography), laboratory parameters (D-Dimer, IMA, IL-6, C-Peeptit, HbA1c, glucose, insulin, Ig E, NT Pro BNP, homocysteine, serotonin, adrenaline, noradrenaline, D vit, CK, CKMB, troponin, myoglobin, urea, uric acid, creatinine, AST, ALT, BIL, ALB, GGT, ALP, LDH, PT, PTT, INR, Sedim, CRP, fibrinogen, procalcitonin, TFT, HDL, LDL, TG, cholesterol, electrolytes and calcium, Mg, CA125, CA15-3, CA19 -9, afp, CEA, hemogram, 5HT-2A receptor, GFR) and anaesthesia and surgery-related parameters (type of anaesthesia; general anaesthesia, local anesthesia) anaesthesia, volume of epidural anaesthetic used, type of local anaesthetic used, opioid use, duration of surgery, duration of anaesthesia, total blood loss
collection of data-3
时间窗: 2 months
IMA measured at certain intervals after cementing. troponin-T measured at intervals, duration of hypotension, duration of hypoxia, medullary lavage, use of cement gun, vacuum cement Mixing and cementing pressure have been reported to be risk factors for the development of BCIS; these data will be collected throughout the study. When and which parameters will be performed will be determined by experienced physicians, and their results will be analysed according to their clinical experience. are interpreted by the algorithms they create.
artificial intelligence modeling
时间窗: 1 months
Artificial Intelligence model process steps The collected data will be made ready for artificial intelligence algorithms by going through the data preprocessing stage. In the feature extraction stage, simple feature extraction algorithms, kurtosis, skewness, local maximum, local minimum, hyperparameters, and principal component analysis processes will be applied. In the classification stage, a dataset is assigned to one of the predetermined classes that are different from each other. Classification algorithms learn which data to assign to which class from the given training set. Then it tries to assign the test data to the correct classes. Logistic regression, linear discriminant analysis, decision trees, Naive Bayes, the K-nearest neighbour algorithm, support vector machines, and random forest algorithms will be used in the classification phase. In the evaluation phase, the best model will be selected by creating an error matrix and interpreting the accuracy value of the model.
次要结局
未报告次要终点
研究者
Muhammed Cagatay Engin
associate professor doctor
Ataturk University