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

Knee Osteoarthritis Clinical Trial

Official title:

Economic Burden of Knee Osteoarthritis in Talavera de la Reina Health Area: a Descriptive Retrospective Observational Study Using Database

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06157723
• Other study ID #: Burden Knee Osteoarthritis
• Status: Recruiting
• Start date: April 1, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: November 2023
• Source: University of Castilla-La Mancha
• Contact: Juan Avendaño Coy, PhD
• Phone: 925268800
• Email: juan.avendano[@]uclm.es
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: January 31, 2024
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Financial Stress
• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Spain	Hospital Nuestra Señora del Prado	Talavera De La Reina	Toledo

Sponsors (1)

Lead Sponsor	Collaborator
University of Castilla-La Mancha

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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	Charlson Comorbidity Index (CCI)	Mortality proGnostic with the Charlson Comorbidity Index (CCI)	Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.
Secondary	Work absences	Number of work absences (temporary and permanent) related with knee osteoarthritis	Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.
Secondary	Physical therapy treatment	To know the number of subjects who received the rehabilitation program for knee osteoarthritis.	Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.