Skip to content

Cardiovascular And Metabolic Risk After Arthroplasty

Cardiovascular And Metabolic Risk After Arthroplasty: the CAMERA Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06211465
Acronym
CAMERA
Enrollment
152
Registered
2024-01-18
Start date
2014-03-01
Completion date
2023-04-30
Last updated
2024-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

metabolomics, arthroplasty, cardiovascular risk, arterial stiffness

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.

Interventions

PROCEDURETotal joint arthroplasty

Hip or knee total joint arthroplasty

Sponsors

Tartu University Hospital
CollaboratorOTHER
Estonian Science Foundation
CollaboratorOTHER_GOV
University of Tartu
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Aortic pulse wave velocity at 5 years after arthroplasty5 years5 years after the beginning of study for control group; measurements are done using the Sphygmocor device.

Secondary

MeasureTime frameDescription
Oxidative stress index5 yearsSerum oxidative stress index. Expressed in %. The percentage of the ratio of total plasma peroxide concentration to plasma total antioxidative capacity (TAC, expressed in mmol trolox equivalent/L).
Leptin levels5 yearsMeasured from serum. Expressed in ng/ml.
Metabolic syndrome risk score5 yearsA composite risk score is used to assess metabolic syndrome risk and include waist circumference(cm), HDL-cholesterol level(mmol/L), fasting glucose level(mmol/L), triglycerides level(mmol/L), blood pressure(mmHg). Each factor gives one point to the total score (range 0-5)
Harris Hip score or Hospital for Special Surgery Knee score5 yearsHarris Hip Score for hip arthroplasty patients. The HHS is divided into three sections. The first section are questions about pain and its impact which are answered by the patient or client. The second and third sections require specialist to assess the patient or client's hip joint and function. The HHS is a measure of dysfunction so the higher the score, the better the outcome for the individual. The maximum score possible is 100. Results can be interpreted with the following: \<70 = poor result; 70-80 = fair, 80-90 = good, and 90-100 = excellent.
Central systolic blood pressure5 yearsCentral systolic blood pressure is measured using the Sphygmocor device. Expressed in mmHg.
Central diastolic blood pressure5 yearsCentral diastolic blood pressure is measured using the Sphygmocor device. Expressed in mmHg.
Changes in low-molecular weight metabolites5 yearsLow-molecular weight metabolites are measured using Biocrates Absolute IDQ p180 kit (BIOCRATES Life Sciences AG, Innsbruck, Austria), which enables to quantify lipides, acylcarnitines, aminoacids, biogenic amines, polyamides
Oxidized LDL-cholesterol5 yearsMeasured from serum. Expressed in mmol/L
Adiponectin level5 yearsMeasured from serum, expressed in ng/ml
Augmentation index5 yearsMeasured using the Sphygmocor device. The augmentation index (AI) is an indirect measure of arterial stiffness and increases with age, and it is calculated as AG (augmentation pressure) divided by PP(pulse pressure) ×100 to give a percentage.
SF-365 yearsThe Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Hospital for Special Surgery knee score5 yearsThe HSS Knee Score is based on a total of 100 points. The score is divided into seven categories, which include pain, function, range of motion, muscle strength, flexion deformity, instability, and subtractions. The knee is initially given a score of 0, and additions or subtractions are made according to specific criteria. The higher the score, the better the outcome. Approximately 50% of the score is based on a patient interview and the remaining on physical exam.
Central pulse pressure5 yearsMeasured using the Sphygmocor device. Expressed in mmHg.
Composite of cardiovascular clinical events5 yearsComposite of stroke, myocardial infarction, cardiovascular death, unstable angina

Countries

Estonia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026