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临床试验/NCT03894514
NCT03894514已完成不适用

Modelo de predicción Multivariable de Resultados de Artroplastia Total de Rodilla

University of Valencia1 个研究点 分布在 1 个国家目标入组 243 人开始时间: 2019年5月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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