Clinical trial NCT06211465: Cardiovascular And Metabolic Risk After Arthroplasty
Official title: Cardiovascular And Metabolic Risk After Arthroplasty: the CAMERA Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis of the Knee
Osteoarthritis of the Hip
Cardiovascular Diseases
Metabolic Syndrome
Keywords: metabolomics
arthroplasty
cardiovascular risk
arterial stiffness
Lead sponsor: University of Tartu
Sponsor class: OTHER
Collaborators: name: Tartu University Hospital
name: Estonian Science Foundation
First posted: 2024-01-18
Enrollment: 152
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary osteoarthritis

Brief summary: 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.


Eligibility criteria: Inclusion Criteria for the arthroplasty group:

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

Exclusion Criteria for the arthroplasty group:

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.

Exclusion criteria for the control group:

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.

Primary outcomes:
measure: Aortic pulse wave velocity at 5 years after arthroplasty
timeFrame: 5 years
Secondary outcomes:
measure: Changes in low-molecular weight metabolites
timeFrame: 5 years
measure: Oxidative stress index
timeFrame: 5 years
measure: Leptin levels
timeFrame: 5 years
measure: Metabolic syndrome risk score
timeFrame: 5 years
measure: Harris Hip score or Hospital for Special Surgery Knee score
timeFrame: 5 years
measure: Central systolic blood pressure
timeFrame: 5 years
measure: Central diastolic blood pressure
timeFrame: 5 years
measure: Composite of cardiovascular clinical events
timeFrame: 5 years
measure: Oxidized LDL-cholesterol
timeFrame: 5 years
measure: Adiponectin level
timeFrame: 5 years
measure: Augmentation index
timeFrame: 5 years
measure: SF-36
timeFrame: 5 years
measure: Hospital for Special Surgery knee score
timeFrame: 5 years
measure: Central pulse pressure
timeFrame: 5 years
Other outcomes:
Locations:
city: Tartu
country: Estonia
facility: University of Tartu
state: Tartumaa
Study officials:
affiliation: University of Tartu
name: Kaspar Tootsi, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Tartu
name: Kadri Vilba, MD
role: STUDY_CHAIR
affiliation: University of Tartu
name: Aare Märtson, PhD, MD
role: STUDY_CHAIR
affiliation: University of Tartu
name: Jaak Kals, PhD, MD
role: STUDY_CHAIR
References: