Comorbidities and Indirect Health State Utility in Hip and Knee Osteoarthritis

NCT ID: NCT02879890

Last Updated: 2016-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

878 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-03-31

Study Completion Date

2014-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

National cohort study aimed to investigate the impact of comorbidities (number and type of comorbidities) on health utility state change in lower lim osteoarthritis (hip and knee OA).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The concept of health utility state was developed by economists to explain individual choices and preferences for health states. It is expressed as the "desirability or preference that individuals exhibit for the condition". This health utility state can be measured indirectly using health-relation quality of life questionnaires.

Chronic diseases such as OA are known to be associated with impairment of quality of life. Given that OA prevalence increases with age, OA is often associated with other diseases (comorbidities). A cross-sectional study showed that comorbidities are associated with lower health utility state in OA. Investigation of longitudinal impact of comorbidities on health utility state change is need.

Main objective: Determine the impact of comorbidities on change in health utility state among patients with lower limb OA.

Secondary objective: Determine the Minimal Clinically important Difference in health utility state among patients with lower limb OA.

The COMUTAR study uses longitudinal data from the Knee and Hip Osteoarthritis Longitudinal Assessment (KHOALA) cohort study. Health utility state is measured indirectly using Medical Outcome Study Short Form-36 quality of life questionnaire Comorbidities are assessed using the Functional Comorbidity Index

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Osteoarthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age: 40-75 years
* Uni or bilateral lower limb osteoarthritis (OA) according to the American College of Rheumatology (ACR) and European league against rheumatism (EULAR) criteria

Exclusion Criteria

* Hip or knee prothesis
* Antecedent of osteotomy
* Severe comorbidity
* Adult under legal protection
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Central Hospital, Nancy, France

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

GUILLEMIN Francis, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Francis GUILLEMIN, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

CHRU Nancy

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Comutar1

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.