Clinical trial NCT03894514: Multi-variable Prediction Model of Total Knee Replacement Outcome
Official title: Modelo de predicción Multivariable de Resultados de Artroplastia Total de Rodilla
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Knee Osteoarthritis
Joint Disease
Total Knee Replacement
Arthroplasty Complications
Lead sponsor: University of Valencia
Sponsor class: OTHER
Collaborators: name: Hospital Universitario La Fe
name: Hospital Clínico Universitario de Valencia
First posted: 2019-03-28
Enrollment: 243
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with severe knee osteoarthritis, waiting for total knee replacement surgery

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Over 60 years old
* Severe knee osteoarthritis
* In the surgery waiting list for undergoing total knee replacement surgery

Exclusion Criteria:

* Lobo Mini-mental State examination \< 20 (not able to properly understand the tests and study)
* Vestibular affection that prevents to perform the tests

Primary outcomes:
measure: Length of stay
timeFrame: change from preoperative assessment to six months after surgery
Secondary outcomes:
measure: Oxford knee Score (OKS)
timeFrame: change from preoperative assessment to six months after surgery
measure: International Physical Activity Questionnaires (IPAQ-short form)
timeFrame: change from preoperative assessment to six months after surgery
measure: Euro Quality of Life 5D questionnaire (EQ-5D)
timeFrame: change from preoperative assessment to six months after surgery
measure: Geriatric Depression Scale (GDS) short form
timeFrame: change from preoperative assessment to six months after surgery
measure: Visual Analogue Scale (VAS) of Pain
timeFrame: change from preoperative assessment to six months after surgery
measure: Expectations (Pain and Function)
timeFrame: change from preoperative assessment to six months after surgery
measure: Strength
timeFrame: change from preoperative assessment to six months after surgery
measure: Range of Motion
timeFrame: change from preoperative assessment to six months after surgery
measure: Timed Up & Go
timeFrame: change from preoperative assessment to six months after surgery
measure: Five times sit to stand test
timeFrame: change from preoperative assessment to six months after surgery
measure: One leg balance test
timeFrame: change from preoperative assessment to six months after surgery
Other outcomes:
measure: Romberg test (open eyes)
timeFrame: change from preoperative assessment to six months after surgery
measure: Comorbidities
timeFrame: baseline assessment
Locations:
city: Valencia
country: Spain
facility: University of Valencia. Facultat de Fisioterapia
Study officials:
References: