Cardiovascular And Metabolic Risk After Arthroplasty

Completed

• Conditions: Cardiovascular Diseases; Osteoarthritis of the Knee; Osteoarthritis of the Hip; Metabolic Syndrome
• Interventions: Procedure: Total joint arthroplasty

• Registration Number: NCT06211465
• Lead Sponsor: University of Tartu

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-01
• Study First Submitted: 2020-12-30
• Primary Completion: 2023-01
• Study Completion: 2023-04
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-08
• Last Update Submitted: 2024-01-08
• Study First Posted: 2024-01-18
• Last Update Posted: 2024-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	Total joint arthroplasty	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.

Primary Outcome Measures

Name	Time	Method
Aortic pulse wave velocity at 5 years after arthroplasty	5 years	5 years after the beginning of study for control group; measurements are done using the Sphygmocor device.

Secondary Outcome Measures

Name	Time	Method
Central systolic blood pressure	5 years	Central systolic blood pressure is measured using the Sphygmocor device. Expressed in mmHg.
Changes in low-molecular weight metabolites	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
Metabolic syndrome risk score	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)
Augmentation index	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.
Central diastolic blood pressure	5 years	Central diastolic blood pressure is measured using the Sphygmocor device. Expressed in mmHg.
Central pulse pressure	5 years	Measured using the Sphygmocor device. Expressed in mmHg.
Composite of cardiovascular clinical events	5 years	Composite of stroke, myocardial infarction, cardiovascular death, unstable angina
Oxidized LDL-cholesterol	5 years	Measured from serum. Expressed in mmol/L
Hospital for Special Surgery knee score	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.
Leptin levels	5 years	Measured from serum. Expressed in ng/ml.
Oxidative stress index	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).
Harris Hip score or Hospital for Special Surgery Knee score	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.
Adiponectin level	5 years	Measured from serum, expressed in ng/ml
SF-36	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.

Trial Locations

Locations (1)

University of Tartu; 🇪🇪 Tartu, Tartumaa, Estonia