Modelo de predicción Multivariable de Resultados de Artroplastia Total de Rodilla
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 243
- 试验地点
- 1
- 主要终点
- Length of stay
研究概览
简要总结
Total knee arthroplasty (TKA) is a surgical procedure applied as a common solution to overcome limitations produced by advanced stages of severe gonarthrosis. The procedure has high prevalence, high associated costs, and is considered to be cost-effective. Rehabilitation is essential to optimize outcomes. However, in clinical practice, the length of rehabilitation for each patient may be highly variable, and the programmed times may lack the necessary objectivity. Current limitation of resources and increasing prevalence make essential to generate strategies to optimize surgical results, so that the use of resources of the health system is efficient without detriment to the patient's benefit. For this purpose, objective and pragmatic information must be available, and should be based on scientific evidence in order to assist in making clinical decisions. Indeed, a number of demographic, biomedical and psychosocial factors have been identified as predictors of TKA results (i.e weight, age, expectations...). Some of them have been associated with the need for hospital resources after surgery. However, most researches base their predictions in retrospective studies, which are limited in the type of variables that can be used (clinic history), quality of registries, and limitations of retrospective designs. On the other hand, most of prospective researches base their predictions in a limited number of outcomes. To overcome this limitations, this project has been designed as a prospective observational study with two observations of each patient.
- The primary goal is to implement a multi-variable prediction model of TKA outcome, so that the procedure become optimal in two aspects : patient recovery (social and economic benefit) and use of health system resources (economic benefit). The implementation requires a processing of the information sampled through various algorithms and innovative data processing in this field, based on data mining and machine learning techniques. This will be used in search of the model with the greatest predictive capacity.
- As a secondary objective, information extracted from patients both in the final stages of the condition, and in the medium term after the intervention will allow to study the functional and psychosocial reality of the subjects with knee osteoarthritis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Over 60 years old
- •Severe knee osteoarthritis
- •In the surgery waiting list for undergoing total knee replacement surgery
排除标准
- •Lobo Mini-mental State examination < 20 (not able to properly understand the tests and study)
- •Vestibular affection that prevents to perform the tests
结局指标
主要结局
Length of stay
时间窗: change from preoperative assessment to six months after surgery
Length of in-hospital rehabilitation
次要结局
- Oxford knee Score (OKS)(change from preoperative assessment to six months after surgery)
- International Physical Activity Questionnaires (IPAQ-short form)(change from preoperative assessment to six months after surgery)
- Euro Quality of Life 5D questionnaire (EQ-5D)(change from preoperative assessment to six months after surgery)
- Strength(change from preoperative assessment to six months after surgery)
- Geriatric Depression Scale (GDS) short form(change from preoperative assessment to six months after surgery)
- Visual Analogue Scale (VAS) of Pain(change from preoperative assessment to six months after surgery)
- Expectations (Pain and Function)(change from preoperative assessment to six months after surgery)
- Timed Up & Go(change from preoperative assessment to six months after surgery)
- One leg balance test(change from preoperative assessment to six months after surgery)
- Range of Motion(change from preoperative assessment to six months after surgery)
- Five times sit to stand test(change from preoperative assessment to six months after surgery)
