Knee OsteoarthritisNCT03894514
Multi-variable Prediction Model of Total Knee Replacement Outcome
An observational study of Knee Osteoarthritis and Joint Disease, run by University of Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Knee Osteoarthritis, Joint Disease, Total Knee Replacement
- How many people
- 243 participants
- Where
- 1 siteSpain
- Study dates
- 1 May 2019to 15 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with severe knee osteoarthritis, waiting for total knee replacement surgery
Who may be able to join
- Over 60 years old
- Severe knee osteoarthritis
- In the surgery waiting list for undergoing total knee replacement surgery
Who cannot join
- Lobo Mini-mental State examination < 20 (not able to properly understand the tests and study)
- Vestibular affection that prevents to perform the tests
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Modelo de predicción Multivariable de Resultados de Artroplastia Total de Rodilla
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.
- Medical subject headings
- Osteoarthritis, Knee, Joint Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay
Length of in-hospital rehabilitation
Measured: change from preoperative assessment to six months after surgery
Secondary outcomes (11)
Oxford knee Score (OKS)
Patient Reported Outcome questionnaire to specifically assess the patient's perspective of outcome following Total Knee Arthroplasty. The OKS consists of twelve questions covering function and pain associated with the knee. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes
Measured: change from preoperative assessment to six months after surgery
International Physical Activity Questionnaires (IPAQ-short form)
This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives. It consists of open-ended questions surrounding individuals' last 7-day recall of physical activity. Total physical activity is estimated in metabolic (MET) MET-min/week and time spent sitting. Then three level or categories are proposed (1=low, 2=moderate and 3=high level of physical activity)
Measured: change from preoperative assessment to six months after surgery
Euro Quality of Life 5D questionnaire (EQ-5D)
This is a measure of health-related quality of life. The EQ-5D consists of a descriptive system and the EQ VAS. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, with 3 possible answers; the score is obtained from the possible binary combination of answers, and interpreted using the visual analogue scale validation technique for the Spanish population.
Measured: change from preoperative assessment to six months after surgery
Geriatric Depression Scale (GDS) short form
Yesavage Scale. The short form of this questionnaire consists of a 15-item self-report assessment used to identify depression in older adults. Questions are answered "yes" or "no", and results consider and individual to be non depressed (normal<5), probably depressed (mild=5<10) and very likely to ve depressed (severe>10)
Measured: change from preoperative assessment to six months after surgery
Visual Analogue Scale (VAS) of Pain
A visual analog scale is used to assess the perceived knee pain. The participant specifies their level of knee pain by indicating a position along a continuous line between 0, no pain, and 10, worse possible pain
Measured: change from preoperative assessment to six months after surgery
Expectations (Pain and Function)
The individual is asked: "How do you expect to feel after the operation?". The level of expectation is answered with a Likert scale ranging from much worse to much better.
Measured: change from preoperative assessment to six months after surgery
Strength
Quadriceps isometric strength as measured with hand-held dynamometer
Measured: change from preoperative assessment to six months after surgery
Range of Motion
Knee range of motion as measured in degrees with a telescopic goniometer
Measured: change from preoperative assessment to six months after surgery
Timed Up & Go
A timed test used as a measure of mobility and dynamic balance in which the individual raises from an arm-chair, walks three meters, turn round a cone, and go back to sit again
Measured: change from preoperative assessment to six months after surgery
Five times sit to stand test
A measure of physical performance. The functional strength of the lower extremities, the transition movements, the balance and the risk of falls are evaluated. The time spent in getting up from a chair for five times is recorded
Measured: change from preoperative assessment to six months after surgery
One leg balance test
A measure of static balance. The time the patient is able to stand on one leg keeping balance is recorded
Measured: change from preoperative assessment to six months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study start1 May 2019
- Primary completion15 May 2021
- Study completion15 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario La Fe, Hospital Clínico Universitario de Valencia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03894514
- Sponsor's protocol ID
- LOS_ATR
- Status last verified
- Mar 2019
- First submitted
- 22 Mar 2019
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modelo de predicción Multivariable de Resultados de Artroplastia Total de Rodilla
- ClinicalTrials.gov ID
- NCT03894514
- Acronym / sponsor ID
- LOS_ATR
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Collaborators
- Hospital Universitario La Fe, Hospital Clínico Universitario de Valencia
- Study start
- 1 May 2019 (actual)
- Primary completion
- 15 May 2021 (actual)
- Study completion
- 15 May 2021 (actual)
- First posted
- 28 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with severe knee osteoarthritis, waiting for total knee replacement surgery
Key inclusion criteria (3 listed)
- Over 60 years old
- Severe knee osteoarthritis
- In the surgery waiting list for undergoing total knee replacement surgery
Key exclusion criteria (2 listed)
- Lobo Mini-mental State examination < 20 (not able to properly understand the tests and study)
- Vestibular affection that prevents to perform the tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Length of stay
Time frame: change from preoperative assessment to six months after surgery
Length of in-hospital rehabilitation
11 secondary outcomes
Oxford knee Score (OKS)
Time frame: change from preoperative assessment to six months after surgery
International Physical Activity Questionnaires (IPAQ-short form)
Time frame: change from preoperative assessment to six months after surgery
Euro Quality of Life 5D questionnaire (EQ-5D)
Time frame: change from preoperative assessment to six months after surgery
Geriatric Depression Scale (GDS) short form
Time frame: change from preoperative assessment to six months after surgery
Visual Analogue Scale (VAS) of Pain
Time frame: change from preoperative assessment to six months after surgery
Expectations (Pain and Function)
Time frame: change from preoperative assessment to six months after surgery
Strength
Time frame: change from preoperative assessment to six months after surgery
Range of Motion
Time frame: change from preoperative assessment to six months after surgery
Timed Up & Go
Time frame: change from preoperative assessment to six months after surgery
Five times sit to stand test
Time frame: change from preoperative assessment to six months after surgery
One leg balance test
Time frame: change from preoperative assessment to six months after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Joint Disease, run by University of Valencia at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay (time frame: change from preoperative assessment to six months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2021.