NCT06984315

Brief Summary

In total knee arthroplasty, surgical and anesthetic procedures can lead to a significant increase in systemic inflammation. This procedure is frequently performed under either general or spinal anesthesia. However, studies investigating the effect of anesthesia type on systemic inflammation have shown conflicting results. The Systemic Inflammatory Response Index (SIRI) and the Systemic Immune-Inflammation Index (SII) provide important information about the extent of systemic inflammation. This study aimed to investigate the effects of general and spinal anesthesia on perioperative changes in SII and SIRI during total knee arthroplasty. Between January 2020 and April 2025, data from 849 patients who underwent total knee arthroplasty were retrospectively reviewed. Patients received either spinal anesthesia (Group S) or general anesthesia (Group G). The groups were compared in terms of changes in perioperative SII and SIRI (ΔSII and ΔSIRI), total opioid consumption, postoperative complications, and length of hospital stay.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
849

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 22, 2025

Completed
Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

5.3 years

First QC Date

May 14, 2025

Last Update Submit

May 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Systemic immune inflammation index (SII) and systemic inflammatory response index (SIRI)

    SII = neutrophil X platelet / lymphocyte count and the SIRI = neutrophil X monocyte / lymphocyte count

    Preoperative hemogram values were obtained during routine anesthesia clinic evaluation, typically one day prior to surgery. Postoperative hemogram samples were collected on the day of surgery (postoperative day 0), within 4 to 12 hours after the procedur

Secondary Outcomes (2)

  • Neutrophil lymphocyte ratio (NLR) and platelet lymphocyte ratio (PLR)

    Preoperative hemogram values were obtained during routine anesthesia clinic evaluation, typically one day prior to surgery. Postoperative hemogram samples were collected on the day of surgery (postoperative day 0), within 4 to 12 hours after the procedur

  • Total amount of opioids consumed postoperatively

    Total amount of opioids requirement within the first 24 postoperative hours

Study Arms (2)

Group S

Underwent total knee arthroplasty under spinal anesthesia

Other: The effects of the groups on perioperative inflammation changes were compared.

Group G

Underwent total knee arthroplasty under general anesthesia

Other: The effects of the groups on perioperative inflammation changes were compared.

Interventions

Between January 2020 and April 2025, data from 849 patients who underwent total knee arthroplasty were retrospectively reviewed. Preoperative hemogram values were obtained during routine anesthesia clinic evaluation, typically one day prior to surgery. Postoperative hemogram samples were collected on the day of surgery (postoperative day 0), within 4 to 12 hours after the procedure. Blood parameters included neutrophil, lymphocyte, monocyte, and platelet counts. Based on these values, inflammatory indices such as the neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), systemic immune-inflammation index (SII), and systemic inflammatory response index (SIRI) were calculated.

Group GGroup S

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Between January 2020 and April 2025, data from 849 patients who underwent total knee arthroplasty were retrospectively reviewed.

You may qualify if:

  • Patients aged 18 to 75 years
  • Patients with ASA physical status I or II
  • Patients who have underwent total knee arthroplasty under general or spinal anesthesia

You may not qualify if:

  • Patients with BMI ≥40 kg/m2
  • Patients with ASA physical status ≥III
  • Patients with severe cardiopulmonary or metabolic disorders, coagulation disorders or active infection
  • Patients with known allergies or chronic steroid use
  • Patients with incomplete laboratory data
  • Patients who underwent revision total knee arthroplasty
  • Patients who required intraoperative conversion from spinal to general anesthesia
  • Patients with a history of major trauma and/or emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tokat Gaziosmanpasa University

Tokat Province, 60100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

May 14, 2025

First Posted

May 22, 2025

Study Start

January 1, 2020

Primary Completion

April 1, 2025

Study Completion

May 10, 2025

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will share

The data used to support the findings of this study can be obtained from the corresponding author on request.

Shared Documents
SAP

Locations