Cardiovascular And Metabolic Risk After Arthroplasty

Cardiovascular Diseases Clinical Trial

— CAMERA  

Official title:

Cardiovascular And Metabolic Risk After Arthroplasty: the CAMERA Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06211465
• Other study ID #: 296T-14
• Status: Completed
• Start date: March 1, 2014
• Est. completion date: April 2023

Study information

• Verified date: January 2024
• Source: University of Tartu
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: April 2023
• Est. primary completion date: January 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Total joint arthroplasty
Hip or knee total joint arthroplasty

Locations

Country	Name	City	State
Estonia	University of Tartu	Tartu	Tartumaa

Sponsors (3)

Lead Sponsor	Collaborator
University of Tartu	Estonian Science Foundation, Tartu University Hospital

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aortic pulse wave velocity at 5 years after arthroplasty	5 years after the beginning of study for control group; measurements are done using the Sphygmocor device.	5 years
Secondary	Changes in low-molecular weight metabolites	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	5 years
Secondary	Oxidative stress index	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).	5 years
Secondary	Leptin levels	Measured from serum. Expressed in ng/ml.	5 years
Secondary	Metabolic syndrome risk score	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 years
Secondary	Harris Hip score or Hospital for Special Surgery Knee score	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.	5 years
Secondary	Central systolic blood pressure	Central systolic blood pressure is measured using the Sphygmocor device. Expressed in mmHg.	5 years
Secondary	Central diastolic blood pressure	Central diastolic blood pressure is measured using the Sphygmocor device. Expressed in mmHg.	5 years
Secondary	Composite of cardiovascular clinical events	Composite of stroke, myocardial infarction, cardiovascular death, unstable angina	5 years
Secondary	Oxidized LDL-cholesterol	Measured from serum. Expressed in mmol/L	5 years
Secondary	Adiponectin level	Measured from serum, expressed in ng/ml	5 years
Secondary	Augmentation index	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.	5 years
Secondary	SF-36	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.	5 years
Secondary	Hospital for Special Surgery knee score	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.	5 years
Secondary	Central pulse pressure	Measured using the Sphygmocor device. Expressed in mmHg.	5 years