Cardiovascular And Metabolic Risk After Arthroplasty (CAMERA)

Cardiovascular And Metabolic Risk After Arthroplasty: the CAMERA Study

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Metabolic Syndrome; Osteoarthritis of the Hip; Osteoarthritis of the Knee
• Intervention / Treatment: Procedure: Total joint arthroplasty

• Study Type: Observational
• Enrollment (Actual): 152

Contacts and Locations

Study Locations

• Estonia
  • Tartumaa
    • Tartu, Tartumaa, Estonia, 51014
      • University of Tartu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients with primary osteoarthritis

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cases; 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.	Procedure: Total joint arthroplasty; Hip or knee total joint arthroplasty
Controls; Gender and age matched control group, who is recruited from the general practitioner (GP) list and who are from the same geographical regions as the cases. Excluding criteria: acute or chronic inflammatory disease, GP visitation due to hip or knee problems, persistent knee or hip pain, diabetes, symptomatic coronary disease, dysrhythmias, cerebrovascular or peripheral artery disease, malignancy or renal impairment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Leptin levels	Measured from serum. Expressed in ng/ml.	5 years
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
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
Central systolic blood pressure	Central systolic blood pressure is measured using the Sphygmocor device. Expressed in mmHg.	5 years
Central diastolic blood pressure	Central diastolic blood pressure is measured using the Sphygmocor device. Expressed in mmHg.	5 years
Composite of cardiovascular clinical events	Composite of stroke, myocardial infarction, cardiovascular death, unstable angina	5 years
Oxidized LDL-cholesterol	Measured from serum. Expressed in mmol/L	5 years
Adiponectin level	Measured from serum, expressed in ng/ml	5 years
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
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
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
Central pulse pressure	Measured using the Sphygmocor device. Expressed in mmHg.	5 years

Collaborators and Investigators

• Sponsor: University of Tartu
• Collaborators: Tartu University Hospital; Estonian Science Foundation
• Investigators: Principal Investigator: Kaspar Tootsi, PhD, MD, University of Tartu; Study Chair: Kadri Vilba, MD, University of Tartu; Study Chair: Aare Märtson, PhD, MD, University of Tartu; Study Chair: Jaak Kals, PhD, MD, University of Tartu

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: December 30, 2020
• First Submitted That Met QC Criteria: January 8, 2024
• First Posted (Actual): January 18, 2024

Study Record Updates

• Last Update Posted (Actual): January 18, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: cardiovascular risk; arthroplasty; arterial stiffness; metabolomics
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Insulin Resistance; Hyperinsulinism; Cardiovascular Diseases; Osteoarthritis; Osteoarthritis, Knee; Metabolic Syndrome; Osteoarthritis, Hip
• Other Study ID Numbers: 296T-14

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No