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Economic Burden of Knee Osteoarthritis in Talavera de la Reina Health Area.

U

University of Castilla-La Mancha

Status

Enrolling

Conditions

Knee Osteoarthritis

Treatments

Other: None (Observational study)

Study type

Observational

Funder types

Other

Identifiers

NCT06157723
Burden Knee Osteoarthritis

Details and patient eligibility

About

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).

Full 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.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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).

Trial design

400 participants in 1 patient group

Knee osteoarthritis participants
Description:
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.
Treatment:
Other: None (Observational study)

Trial contacts and locations

1

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Central trial contact

Natalia Comino Suárez, PT, MSc; Juan Avendaño Coy, PhD

Data sourced from clinicaltrials.gov

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