Clinical trial NCT06157723: Economic Burden of Knee Osteoarthritis in Talavera de la Reina Health Area.
Official title: Economic Burden of Knee Osteoarthritis in Talavera de la Reina Health Area: a Descriptive Retrospective Observational Study Using Database
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Knee Osteoarthritis
Keywords: knee osteoarthritis
economic burden
Physical therapy
Retrospective
Observational
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals with a diagnosis of knee osteoarthritis registered in the electronic database of Talavera de la Reina Health Area, Toledo, Spain.

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Healthcare resource use
timeFrame: Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.
measure: Participants sociodemographic characteristics
timeFrame: Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.
measure: Participant clinical characteristics
timeFrame: Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.
Secondary outcomes:
measure: Charlson Comorbidity Index (CCI)
timeFrame: Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.
measure: Work absences
timeFrame: Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.
measure: Physical therapy treatment
timeFrame: Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.
Other outcomes:
Locations:
city: Talavera De La Reina
country: Spain
facility: Hospital Nuestra Señora del Prado
state: Toledo
Study officials:
References: