Cardiovascular And Metabolic Risk After Arthroplasty

NCT ID: NCT06211465

Last Updated: 2024-01-18

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

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Recruitment Status

COMPLETED

Total Enrollment

152 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-01

Study Completion Date

2023-04-30

Brief Summary

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Osteoarthritis is a chronic joint disease that lacks curative therapy. Epidemiological studies show increase in the burden of disease. Total joint arthroplasty is one of the best treatment options for end-stage osteoarthritis. However, the specific effects of total joint arthroplasty on cardiovascular risk and metabolic profile are largely unknown. The aim of this project is to elucidate how hip and knee total joint arthroplasty impacts cardiovascular risk and metabolomic profile in comparison with general population. We hypothesize that arthroplasty decreases pain, systemic inflammation levels and increases functional status that all lead to decreased metabolic and cardiovascular risk.

Detailed Description

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Conditions

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Osteoarthritis of the Knee Osteoarthritis of the Hip Cardiovascular Diseases Metabolic Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cases

Patients with end-stage osteoarthritis (OA), who were eligible for total joint arthroplasty in Tartu University Hospital. Exclusion criteria: posttraumatic OA, infectious or endocrine arthropathy, acute or chronic inflammatory disease, malignancies, end-stage renal impairment (eGFR \< 60ml/min/1.73m2), dysrhythmias, clinically relevant heart failure, heart valve-disease, diabetes.

Total joint arthroplasty

Intervention Type PROCEDURE

Hip or knee total joint arthroplasty

Controls

Gender and age matched control group, who is recruited from the general practitioner (GP) list and who are from the same geographical regions as the cases. Excluding criteria: acute or chronic inflammatory disease, GP visitation due to hip or knee problems, persistent knee or hip pain, diabetes, symptomatic coronary disease, dysrhythmias, cerebrovascular or peripheral artery disease, malignancy or renal impairment.

No interventions assigned to this group

Interventions

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Total joint arthroplasty

Hip or knee total joint arthroplasty

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

primary hip and knee OA (according to the American College of Rheumatology criteria) eligible for total joint arthroplasty

Exclusion Criteria

posttraumatic OA, infectious and endocrine related arthropathy, any acute or chronic inflammatory disease, malignancy, renal insufficiency (estimated glomerular filtration rate (eGFR) \< 60ml/min/1.73m2), cardiac arrhythmia, clinically significant heart failure, valvular disease, diabetes.


any concomitant acute or chronic inflammatory disease, a visit to family practitioner due to hip or knee joint complaints, any persistent knee or hip joint pain, diabetes, symptomatic coronary artery disease, cardiac arrhythmia, cerebrovascular or peripheral artery disease, malignancies and renal insufficiency.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Tartu University Hospital

OTHER

Sponsor Role collaborator

Estonian Science Foundation

OTHER_GOV

Sponsor Role collaborator

University of Tartu

OTHER

Sponsor Role lead

Responsible Party

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Kaspar Tootsi

Orthopedic research fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kaspar Tootsi, PhD, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tartu

Kadri Vilba, MD

Role: STUDY_CHAIR

University of Tartu

Aare Märtson, PhD, MD

Role: STUDY_CHAIR

University of Tartu

Jaak Kals, PhD, MD

Role: STUDY_CHAIR

University of Tartu

Locations

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University of Tartu

Tartu, Tartu, Estonia

Site Status

Countries

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Estonia

Other Identifiers

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296T-14

Identifier Type: -

Identifier Source: org_study_id

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