Knee OsteoarthritisNCT06157723
Economic Burden of Knee Osteoarthritis in Talavera de la Reina Health Area.
An observational study of Knee Osteoarthritis, run by University of Castilla-La Mancha at 1 site in Spain.
Trial summary
This is a descriptive retrospective study of individuals affected with knee osteoarthritis. The aim of this study is to describe the sociodemographic and clinical characteristics of individuals diagnosed with knee osteoarthritis within a specific health area, as well as to assess the economic impact of this condition… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- None (Observational study)
- How many people
- 400 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2023to 31 Jan 2024
- How long will I take part?
- 10 Years
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Individuals with a diagnosis of knee osteoarthritis registered in the electronic database of Talavera de la Reina Health Area, Toledo, Spain.
Who may be able to join
- Patients ≥18 years old.
- Diagnosed with unilateral or bilateral knee osteoarthritis according to the clinical criteria of the American College of Rheumatology.
- Radiographic imaging diagnosis based on the Kellgren \& Lawrence (K-L) classification.
Who cannot join
- No available X-ray.
- Pre-existing neurological diseases before the diagnostic date (stroke, Parkinson's, multiple sclerosis, ALS).
- Connective tissue disorders (Ehlers-Danlos, Marfan). Secondary cause of osteoarthritis or severe osteoarthritis (ACL tears, severe traumas, infections, or sepsis).
- Inflammatory arthropathy (any type of arthritis).
- Genetic disorders with a higher risk of developing arthropathies (Down syndrome).
Trial locations and contacts
1 site in 1 country.
Natalia Comino Suárez, PT, MSc contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Nuestra Señora del Prado
Talavera de la Reina, Toledo, 45600
Javier Aceituno Gómez, PhD, javier.aceituno@uclm.es
About this study
Official title: Economic Burden of Knee Osteoarthritis in Talavera de la Reina Health Area: a Descriptive Retrospective Observational Study Using Database
This is a descriptive retrospective study of individuals affected with knee osteoarthritis. The aim of this study is to describe the sociodemographic and clinical characteristics of individuals diagnosed with knee osteoarthritis within a specific health area, as well as to assess the economic impact of this condition on the healthcare system. To achieve this, medical records will be reviewed, and the following data will be collected:
Sociodemographic and clinical participant data. Healthcare resource use. Clinical burden. Up to 400 subjects will be enrolled in the Talavera de la Reina Health Area (Toledo, Spain).
Read the detailed description
This is a multicenter, observational, retrospective study focusing on individuals diagnosed with knee osteoarthritis. This study will be conducted in the Talavera de la Reina Health Area (Toledo, Spain). Participants will be identified through the codes assigned in the electronic database associated with knee osteoarthritis.
Data will be collected from the initial radiologic diagnostic moment to December 31, 2019. For each participant enrolled, data from medical records will be collected and entered onto an electronic case report form (REDCap).
The sociodemographic and clinical data related to the pathology will be collected, including age, weight, height, duration of the condition, and occupational activity.
The following data will be considered as direct healthcare costs: the number of visits in primary and specialized care, diagnostic tests, surgical interventions, and emergencies at both health centers and hospitals. In addition, pharmacotherapy, rehabilitation number of sessions, and work absences (temporary and permanent) will be registered.
For cost estimation, a prevalence-based approach and a bottom-up estimation will be employed in the monetary valuation of healthcare resources, utilizing official sources.
- Conditions
- Knee Osteoarthritis
- Being tested
- None (Observational study)
- Keywords
- knee osteoarthritis, economic burden, Physical therapy, Retrospective, Observational
- Medical subject headings
- Osteoarthritis, Knee, Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
None (Observational study)Other
Also called Observational study
Data related to the knee osteoarthritis will be extracted from patients' medical records:
The sociodemographic and clinical participants' characteristics: age, weight, height, duration of the condition, and occupational activity.
The healthcare costs: the number of visits in primary and specialized care, diagnostic tests, surgical interventions, and emergencies at both health centers and hospitals, physical rehabilitation and number of sessions.
Charlson Comorbidity Index (CCI). Pharmacotherapy (type of drug and dose). Work absences (temporary and permanent).
| Study group | Role | What they receive |
|---|---|---|
| Knee osteoarthritis participants | Participants who are registered in the Health system electronic database, with a clinical and radiographic diagnostic of knee osteoarthritis. Approximately a total of 400 participants will be enrolled in the study. Receives: Other: None (Observational study) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healthcare resource use
Healthcare resource use will be collected from medical records. The data will be collected by four collaborators from the healthcare system, filling out electronic forms on REDCap.
The health direct cost will be the following:
The number of visits in primary and specialized care and type of health professional, number and type of surgical interventions, and number of emergencies at both health centers and hospitals.
Type and number of diagnostic tests. Pharmacotherapy (type of drug and dose). The number of sessions of physical therapy.
Measured: Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.
Participants sociodemographic characteristics
Age, weight, height and work activity.
Measured: Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.
Participant clinical characteristics
Severity of knee osteoarthritis with the radiographic Kellgren and Lawrence classification.
Disease progression time.
Measured: Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.
Secondary outcomes (3)
Charlson Comorbidity Index (CCI)
Mortality proGnostic with the Charlson Comorbidity Index (CCI)
Measured: Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.
Work absences
Number of work absences (temporary and permanent) related with knee osteoarthritis
Measured: Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.
Physical therapy treatment
To know the number of subjects who received the rehabilitation program for knee osteoarthritis.
Measured: Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start1 Apr 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jan 2024 (estimated)
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
- Other
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natalia Comino Suarez, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157723
- Sponsor's protocol ID
- Burden Knee Osteoarthritis
- Status last verified
- Nov 2023
- First submitted
- 27 Nov 2023
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Qualified researchers can request access to anonymized individual patient data to the IP researcher. All requests will be evaluated as the Talavera de la Reina Ethics Commitee.
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Economic Burden of Knee Osteoarthritis in Talavera de la Reina Health Area: a Descriptive Retrospective Observational Study Using Database
- ClinicalTrials.gov ID
- NCT06157723
- Acronym / sponsor ID
- Burden Knee Osteoarthritis
- Conditions
- Knee Osteoarthritis
- Keywords
- knee osteoarthritis, economic burden, Physical therapy, Retrospective, Observational
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 6 Dec 2023 (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.
This is a descriptive retrospective study of individuals affected with knee osteoarthritis. The aim of this study is to describe the sociodemographic and clinical characteristics of individuals diagnosed with knee osteoarthritis within a specific health area, as well as to assess the economic impact of this condition on the healthcare system. To achieve this, medical records will be reviewed, and the following data will be collected:
Sociodemographic and clinical participant data. Healthcare resource use. Clinical burden. Up to 400 subjects will be enrolled in the Talavera de la Reina Health Area (Toledo, Spain).
Detailed description
This is a multicenter, observational, retrospective study focusing on individuals diagnosed with knee osteoarthritis. This study will be conducted in the Talavera de la Reina Health Area (Toledo, Spain). Participants will be identified through the codes assigned in the electronic database associated with knee osteoarthritis.
Data will be collected from the initial radiologic diagnostic moment to December 31, 2019. For each participant enrolled, data from medical records will be collected and entered onto an electronic case report form (REDCap).
The sociodemographic and clinical data related to the pathology will be collected, including age, weight, height, duration of the condition, and occupational activity.
The following data will be considered as direct healthcare costs: the number of visits in primary and specialized care, diagnostic tests, surgical interventions, and emergencies at both health centers and hospitals. In addition, pharmacotherapy, rehabilitation number of sessions, and work absences (temporary and permanent) will be registered.
For cost estimation, a prevalence-based approach and a bottom-up estimation will be employed in the monetary valuation of healthcare resources, utilizing official sources.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Knee osteoarthritis participants | – | Other: None (Observational study)Participants who are registered in the Health system electronic database, with a clinical and radiographic diagnostic of knee osteoarthritis. Approximately a total of 400 participants will be enrolled in the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Individuals with a diagnosis of knee osteoarthritis registered in the electronic database of Talavera de la Reina Health Area, Toledo, Spain.
Key inclusion criteria (3 listed)
- Patients ≥18 years old.
- Diagnosed with unilateral or bilateral knee osteoarthritis according to the clinical criteria of the American College of Rheumatology.
- Radiographic imaging diagnosis based on the Kellgren \& Lawrence (K-L) classification.
Key exclusion criteria (5 listed)
- No available X-ray.
- Pre-existing neurological diseases before the diagnostic date (stroke, Parkinson's, multiple sclerosis, ALS).
- Connective tissue disorders (Ehlers-Danlos, Marfan). Secondary cause of osteoarthritis or severe osteoarthritis (ACL tears, severe traumas, infections, or sepsis).
- Inflammatory arthropathy (any type of arthritis).
- Genetic disorders with a higher risk of developing arthropathies (Down syndrome).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| None (Observational study)Also: Observational studyData related to the knee osteoarthritis will be extracted from patients' medical records: The sociodemographic and clinical participants' characteristics: age, weight, height, duration of the condition, and occupational activity. The healthcare costs: the number of visits in primary and specialized care, diagnostic tests, surgical interventions, and emergencies at both health centers and hospitals, physical rehabilitation and number of sessions. Charlson Comorbidity Index (CCI). Pharmacotherapy (type of drug and dose). Work absences (temporary and permanent). | Other | Knee osteoarthritis participants |
Primary outcome
Healthcare resource use
Time frame: Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.
Healthcare resource use will be collected from medical records. The data will be collected by four collaborators from the healthcare system, filling out electronic forms on REDCap. The health direct cost will be the following: The number of visits in primary and specialized care and type of health professional, number and type of surgical interventions, and number of emergencies at both health centers and hospitals. Type and number of diagnostic tests. Pharmacotherapy (type of drug and dose). The number of sessions of physical therapy.
Participants sociodemographic characteristics
Time frame: Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.
Age, weight, height and work activity.
Participant clinical characteristics
Time frame: Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.
Severity of knee osteoarthritis with the radiographic Kellgren and Lawrence classification. Disease progression time.
3 secondary outcomes
Charlson Comorbidity Index (CCI)
Time frame: Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.
Work absences
Time frame: Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.
Physical therapy treatment
Time frame: Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: Undecided. Qualified researchers can request access to anonymized individual patient data to the IP researcher. All requests will be evaluated as the Talavera de la Reina Ethics Commitee.
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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.
Natalia Comino Suárez, PT, MSc contact
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, run by University of Castilla-La Mancha 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 5 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: status not confirmed, as of the sponsor's last update on 6 Dec 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Juan Avendaño Coy, PhD (925268800 ext. 5423, juan.avendano@uclm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healthcare resource use (time frame: Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.). The study lists 3 primary outcomes in all. 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 6 Dec 2023.