The Immu-KNEE-ty Study

NCT05920148 | Completed

• 1 other identifier: NL84069.091.23
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to determine changes in immune functioning after total knee replacement surgery in elderly. The study population consists of 14 patients aged 65 years or over undergoing primary total knee replacement surgery. Immune functioning will be assessed at multiple timepoints before and after surgery (i.e., ± 6 weeks before, and 1 day, 1 week, ± 2 weeks, and ± 6 weeks after surgery). Each patient will serve as his/her own control. Immune functioning will primarily be assessed by determining the change from baseline in monocyte-derived TNFα production at 1 week after surgery. Changes in monocyte responsiveness are considered indicative for changes in immune functioning. As secondary objective, additional parameters of immune functioning will be assessed. In addition, the course of immune functioning following total knee replacement surgery will be investigated. Burden and potential risks for the patient are estimated to be minor. During the study, 5 blood samples of 20 mL will be collected over a period of ± 12 weeks, resulting in a total blood draw of 100 mL. During surgery a sample of synovial fluid (± 2 mL) will be taken from surgical waste. Before and after surgery patients will report their pain medication intake and the presence of cold and flu-like symptoms in a diary. Patients do not directly benefit from the study.

Conditions

Immunosenescence; Aging

Keywords

Knee arthroplasty; Elderly; Immune functioning; Monocytes

Outcome Measures

Primary Outcomes (1)

• Monocyte-derived TNFa production

  TNFα production after ex vivo stimulation of whole blood with inflammatory stimuli corrected for monocyte count

  Change from baseline at 1 week after surgery

Secondary Outcomes (30)

• Monocyte-derived cytokine production

  Change from baseline at 1 day after surgery

• Monocyte-derived cytokine production

  Change from baseline at 1 week after surgery

• Monocyte-derived cytokine production

  Change from baseline at ± 2 weeks after surgery

• Monocyte-derived cytokine production

  Change from baseline at ± 6 weeks after surgery

• Monocyte-derived cytokine production

  Change from baseline at 1 day after surgery

Other Outcomes (16)

• Body Mass Index

  Baseline

• American Society of Anesthesiologists (ASA) classification

  Baseline

• Kellgren-Lawrence classification

  Baseline

Study Arms (1)

Elderly

Procedure: Knee arthroplasty

Interventions

Knee arthroplasty PROCEDURE

At multiple timepoints (i.e., ± 6 weeks before, and 1 day, 1 week, ± 2 weeks, and ± 6 weeks after surgery) before and after total knee replacement surgery blood will be collected to assess immune functioning

Elderly

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of 14 patients (classified as ASA II or ASA III) aged 65 years or over, diagnosed with osteoarthritis, undergoing primary total knee replacement surgery.

You may qualify if:

• Planned for primary total knee replacement surgery
• Aged 65 years or over
• Diagnosed with osteoarthritis
• ASA Physical Status Classification of II or III
• Willing to donate a blood sample at 5 different timepoints
• Able to give written informed consent

You may not qualify if:

• Use of systemic corticosteroids
• Current diagnosis of cancer
• Diagnosed with a primary immunodeficiency disorder (e.g., Severe Combined Immunodeficiency (SCID), Common Variable Immune Deficiency (CVID), X-linked agammaglobulinemia, selective immunoglobulin A deficiency, chronic granulomatous disease)
• Current participation in other scientific research

Sponsors & Collaborators

• Wageningen University: lead
• Wageningen University and Research: collaborator
• Gelderse Vallei Hospital: collaborator

Study Sites (1)

Gelderse Vallei Hospital

Ede, 6716 RP, Netherlands

Location

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator / Associate Professor

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: June 27, 2023
• Study Start: March 12, 2024
• Primary Completion: December 11, 2024
• Study Completion: December 11, 2024
• Last Updated: March 4, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)