Cardiovascular And Metabolic Risk After Arthroplasty

NCT06211465 | Completed

• 1 other identifier: 296T-14
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

metabolomics; arthroplasty; cardiovascular risk; arterial stiffness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (14)

• Changes in low-molecular weight metabolites

  5 years

• Oxidative stress index

  5 years

• Leptin levels

  5 years

• Metabolic syndrome risk score

  5 years

• Harris Hip score or Hospital for Special Surgery Knee score

  5 years

Study Arms (2)

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

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.

Interventions

Total joint arthroplasty PROCEDURE

Hip or knee total joint arthroplasty

Cases

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary osteoarthritis

You may qualify if:

• primary hip and knee OA (according to the American College of Rheumatology criteria) eligible for total joint arthroplasty

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University of Tartu: lead
• Tartu University Hospital: collaborator
• Estonian Science Foundation: collaborator

Study Sites (1)

University of Tartu

Tartu, Tartu, 51014, Estonia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and plasma

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip; Cardiovascular Diseases; Metabolic Syndrome

Interventions

Arthroplasty, Replacement

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Kaspar Tootsi, PhD, MD

  University of Tartu

  PRINCIPAL INVESTIGATOR

• 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 CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic research fellow

Study Record Dates

• First Submitted: December 30, 2020
• First Posted: January 18, 2024
• Study Start: March 1, 2014
• Primary Completion: January 1, 2023
• Study Completion: April 1, 2023
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)