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Completed

NCT Number: NCT06211465

Cardiovascular And Metabolic Risk After Arthroplasty

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

total joint arthroplasty

Procedure

Hip or knee total joint arthroplasty

Primary outcomes

  1. Aortic pulse wave velocity at 5 years after arthroplasty

    Time frame: 5 years

    5 years after the beginning of study for control group; measurements are done using the Sphygmocor device.

Secondary outcomes

  1. Changes in low-molecular weight metabolites

    Time frame: 5 years

    Low-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

  2. Oxidative stress index

    Time frame: 5 years

    Serum 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).

  3. Leptin levels

    Time frame: 5 years

    Measured from serum. Expressed in ng/ml.

  4. Metabolic syndrome risk score

    Time frame: 5 years

    A 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)

  5. Harris Hip score or Hospital for Special Surgery Knee score

    Time frame: 5 years

    Harris 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.

  6. Central systolic blood pressure

    Time frame: 5 years

    Central systolic blood pressure is measured using the Sphygmocor device. Expressed in mmHg.

  7. Central diastolic blood pressure

    Time frame: 5 years

    Central diastolic blood pressure is measured using the Sphygmocor device. Expressed in mmHg.

  8. Composite of cardiovascular clinical events

    Time frame: 5 years

    Composite of stroke, myocardial infarction, cardiovascular death, unstable angina

  9. Oxidized LDL-cholesterol

    Time frame: 5 years

    Measured from serum. Expressed in mmol/L

  10. Adiponectin level

    Time frame: 5 years

    Measured from serum, expressed in ng/ml

  11. Augmentation index

    Time frame: 5 years

    Measured 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.

  12. SF-36

    Time frame: 5 years

    The 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.

  13. Hospital for Special Surgery knee score

    Time frame: 5 years

    The 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.

  14. Central pulse pressure

    Time frame: 5 years

    Measured using the Sphygmocor device. Expressed in mmHg.

Sponsors and collaborators

Lead sponsor

University of Tartu

Other

Collaborators

  • Estonian Science Foundation
  • Tartu University Hospital

Registry information

Official study title

Cardiovascular And Metabolic Risk After Arthroplasty: the CAMERA Study

Acronym: CAMERA

Important dates

Study start
2014
Primary completion
2023
Study completion
2023
First posted
Jan 18, 2024
Registry last updated
Jan 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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