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

November 27, 2023 updated by: Natalia Comino Suarez, University of Castilla-La Mancha

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
    • Toledo
      • Talavera De La Reina, Toledo, Spain, 45600
        • Recruiting
        • Hospital Nuestra Señora del Prado
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)

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 Names:
  • Observational study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthcare resource use
Time Frame: Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.

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

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Charlson Comorbidity Index (CCI)
Time Frame: Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.
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.
Work absences
Time Frame: Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.
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.
Physical therapy treatment
Time Frame: Data will be collected from from the initial radiologic diagnosis registered in the electronic database to December 31, 2019.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Castilla-La Mancha

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

January 31, 2024

Study Registration Dates

First Submitted

November 27, 2023

First Submitted That Met QC Criteria

November 27, 2023

First Posted (Actual)

December 6, 2023

Study Record Updates

Last Update Posted (Actual)

December 6, 2023

Last Update Submitted That Met QC Criteria

November 27, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Burden Knee Osteoarthritis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Qualified researchers can request access to anonymized individual patient data to the IP researcher. All requests will be evaluated as the Talavera de la Reina Ethics Commitee.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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