Economic Burden of Knee Osteoarthritis in Talavera de la Reina Health Area.
NCT ID: NCT06157723
Last Updated: 2023-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
400 participants
OBSERVATIONAL
2023-04-01
2024-01-31
Brief Summary
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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
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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
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Keywords
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Study Design
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OTHER
OTHER
Study Groups
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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.
None (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).
Interventions
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None (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).
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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).
18 Years
ALL
No
Sponsors
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University of Castilla-La Mancha
OTHER
Responsible Party
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Natalia Comino Suarez
PhD
Locations
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Hospital Nuestra Señora del Prado
Talavera de la Reina, Toledo, Spain
Countries
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Central Contacts
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Facility Contacts
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Javier Aceituno Gómez, PhD
Role: primary
Other Identifiers
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Burden Knee Osteoarthritis
Identifier Type: -
Identifier Source: org_study_id