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

NCT06157723 | Unknown

• 1 other identifier: Burden Knee Osteoarthritis
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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).

Conditions

Knee Osteoarthritis

Keywords

knee osteoarthritis; economic burden; Physical therapy; Retrospective; Observational

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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)

  Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.

• Work absences

  Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.

• Physical therapy treatment

  Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.

Study Arms (1)

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.

Other: None (Observational study)

Interventions

None (Observational study) OTHER

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).

Also known as: Observational study

Knee osteoarthritis participants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Castilla-La Mancha: lead

Study Sites (1)

Hospital Nuestra Señora del Prado

Talavera de la Reina, Toledo, 45600, Spain

RECRUITING

MeSH Terms

Conditions

Osteoarthritis, Knee; Financial Stress

Interventions

Observation

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Juan Avendaño Coy, PhD

CONTACT

925268800; juan.avendano@uclm.es

Natalia Comino Suárez, PT, MSc

CONTACT

natalia.comino@uclm.es

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 6, 2023
• Study Start: April 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 31, 2024
• Last Updated: December 6, 2023

Record last verified: 2023-11

Locations

ES (1)