The effect of total knee replacement surgery on immune functioning in elderly

Recruiting

Conditions: immunosenescentie
aging
Immunosenescence

Registration Number: NL-OMON53227

Lead Sponsor: Wageningen Universiteit

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 14

Inclusion Criteria

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

Exclusion Criteria

- Daily use of high doses NSAIDs within the 14 days before inclusion: Defined as higher than maintenance dose in the *farmacotherapeutisch kompas*. For example: acetylsalicylic acid > 4 g /day; diclofenac > 75 mg/day; naproxen > 500 mg/day; ibuprofen> 1600 mg/day; celecoxib > 200 mg/day - Use of systemic corticosteroids - Use of antibiotics within the 14 days before inclusion - 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) - Vaccination (e.g., immunization against COVID-19, influenza, pneumonia, and travel-related infections) within the 14 days before inclusion and during the study period - Current participation in other scientific research

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameter is the change from baseline in monocyte-derived TNFa<br /><br>production at 1 week after surgery. TNFa production will be measured after ex<br /><br>vivo stimulation of whole blood with inflammatory stimuli and normalized for<br /><br>monocyte count. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are:<br /><br>- Change from baseline in monocyte-derived cytokine production at 1 day, 1<br /><br>week, ± 2 weeks and ± 6 weeks post-surgery.<br /><br>- Change from baseline in additional parameters of immune functioning at 1 day,<br /><br>1 week, ± 2 weeks and ± 6 weeks post-surgery. These additional parameters of<br /><br>immune functioning are:<br /><br>• Composition of immune cell populations (monocytes, lymphocytes,<br /><br>neutrophils, eosinophils, basophils)<br /><br>• Systemic inflammation<br /><br>• Phagocytic function of monocytes<br /><br>• Monocyte HLA-DR expression<br /><br>- Synovial inflammation.<br /><br>- Other study parameters: sex, age, BMI, ASA classification, Kellgren-Lawrence<br /><br>classification, Patient Reported Outcome Measures (PROMs), functional outcomes,<br /><br>amount and period of use of analgesic therapies and presence of cold and<br /><br>flu-like symptoms.</p><br>