Inflammatory Response in Total Knee ArthroplastyDNA-TKANCT07214558
Spinal Versus General Anesthesia and Inflammatory Response Measured by Delta Neutrophil Index in Total Knee Arthroplasty: An Observational Study
An observational study of Inflammatory Response in Total Knee Arthroplasty, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
This study aims to compare the effects of spinal versus general anesthesia on the inflammatory response measured by Delta Neutrophil Index (DNI) in patients undergoing total knee arthroplasty. The study is prospective and observational. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Inflammatory Response in Total Knee Arthroplasty
- What is being tested?
- Routine Clinical Anesthesia Practice
- How many people
- 84 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Sep 2025to 22 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients undergoing elective total knee arthroplasty at Elazig Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation.
Who may be able to join
- Patients scheduled for total knee arthroplasty
- Age ≥ 18 years
- ASA physical status classification I-III
Who cannot join
- Active infection
- Hematologic disease (e.g., leukemia, aplastic anemia)
- Autoimmune or chronic inflammatory disease
- Use of corticosteroids or immunosuppressive drugs
- Malignancy
- Acute trauma or sepsis
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Elazığ Fethi Sekin City Hospital
Elâzığ, Merkez, 23200
About this study
Official title: he Effect of Spinal and General Anesthesia on Inflammatory Response Measured by Delta Neutrophil Index in Patients Undergoing Total Knee Arthroplasty: A Prospective Observational Study
This study aims to compare the effects of spinal versus general anesthesia on the inflammatory response measured by Delta Neutrophil Index (DNI) in patients undergoing total knee arthroplasty. The study is prospective and observational. A total of at least 84 patients will be included, with anesthesia type determined according to routine clinical practice. Preoperative and postoperative blood tests will be analyzed, and no additional blood samples will be required.
Read the detailed description
This prospective observational study will be conducted at Elazig Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation. Patients undergoing total knee arthroplasty will be assigned to two groups based on the anesthesia method used in routine practice: spinal anesthesia or general anesthesia. The primary outcome measure is the Delta Neutrophil Index (DNI), an inflammation marker automatically calculated by hematology analyzers using complete blood count parameters. DNI values will be compared preoperatively and postoperatively between groups. Additional data including age, sex, ASA classification, duration of surgery, hemogram parameters, and perioperative complications will be collected. The sample size calculation indicated that a minimum of 42 patients per group (total 84) are required to detect significant differences in DNI levels with 80% power at a 5% significance level. Statistical analyses will include Kolmogorov-Smirnov test for normality, independent t test or Mann-Whitney U test for between-group comparisons, and paired t test or Wilcoxon test for within-group comparisons. A p-value <0.05 will be considered statistically significant.
- Being tested
- Routine Clinical Anesthesia Practice
- Keywords
- Total Knee Arthroplasty, Spinal Anesthesia, General Anesthesia, Delta Neutrophil Index, Inflammatory Response
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine Clinical Anesthesia PracticeOther
Patients undergoing total knee arthroplasty will receive either spinal or general anesthesia as determined by routine clinical practice and the attending anesthesiologist's decision. Investigators will not influence the choice of anesthesia method.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Anesthesia Group | Patients undergoing total knee arthroplasty under spinal anesthesia. The choice of anesthesia is based on clinical decision-making in routine practice. Receives: Other: Routine Clinical Anesthesia Practice | |
| General Anesthesia Group | Patients undergoing total knee arthroplasty under general anesthesia. The choice of anesthesia is based on clinical decision-making in routine practice. Receives: Other: Routine Clinical Anesthesia Practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Delta Neutrophil Index (DNI)
Difference in DNI values measured preoperatively and postoperatively in patients undergoing total knee arthroplasty under spinal versus general anesthesia.
Measured: From baseline (preoperative) to 24 hours postoperative.
Secondary outcomes (5)
Neutrophil Count
Absolute neutrophil count measured preoperatively and at 24 hours postoperatively.
Measured: Preoperative to 24 hours postoperative.
Perioperative Complications
Incidence of complications such as infection, bleeding, or cardiovascular events.
Measured: Intraoperative and during hospital stay (up to 7 days).
Operative Time
Duration of surgery recorded in minutes.
Measured: Intraoperative period.
Lymphocyte Count
Absolute lymphocyte count measured preoperatively and at 24 hours postoperatively.
Measured: Preoperative to 24 hours postoperative.
Neutrophil-to-Lymphocyte Ratio (NLR)
NLR calculated from complete blood count values preoperatively and at 24 hours postoperatively.
Measured: Preoperative to 24 hours postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start22 Sep 2025
- Primary completion22 Oct 2025
- Study completion22 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Response in Total Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elazıg Fethi Sekin Sehir Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sevim Şenol Karataş, Elazıg Fethi Sekin Sehir Hastanesi
- Investigators
- Sevim Şenol Karataş, Principal investigator, Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214558
- Sponsor's protocol ID
- EFSH-ANES-2025-09-DELTANEUTROP
- Acronym
- DNA-TKA
- Status last verified
- Nov 2025
- First submitted
- 22 Sep 2025
- Last updated
- 26 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the study is single-center, observational, and involves routine clinical laboratory results that are stored only in hospital records.
Publications
Bozan MB, Yazar FM, Kale IT, Yuzbasioglu MF, Boran OF, Azak Bozan A. Delta Neutrophil Index and Neutrophil-to-Lymphocyte Ratio in the Differentiation of Thyroid Malignancy and Nodular Goiter. World J Surg. 2021 Feb;45(2):507-514. doi: 10.1007/s00268-020-05822-6. Epub 2020 Oct 16.
PubMed 33067685Nahm CH, Choi JW, Lee J. Delta neutrophil index in automated immature granulocyte counts for assessing disease severity of patients with sepsis. Ann Clin Lab Sci. 2008 Summer;38(3):241-6.
PubMed 18715852
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- he Effect of Spinal and General Anesthesia on Inflammatory Response Measured by Delta Neutrophil Index in Patients Undergoing Total Knee Arthroplasty: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07214558
- Acronym / sponsor ID
- DNA-TKA / EFSH-ANES-2025-09-DELTANEUTROP
- Keywords
- Total Knee Arthroplasty, Spinal Anesthesia, General Anesthesia, Delta Neutrophil Index, Inflammatory Response
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Elazıg Fethi Sekin Sehir HastanesiUniversity, hospital or other
- Study start
- 22 Sep 2025 (actual)
- Primary completion
- 22 Oct 2025 (actual)
- Study completion
- 22 Oct 2025 (actual)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the effects of spinal versus general anesthesia on the inflammatory response measured by Delta Neutrophil Index (DNI) in patients undergoing total knee arthroplasty. The study is prospective and observational. A total of at least 84 patients will be included, with anesthesia type determined according to routine clinical practice. Preoperative and postoperative blood tests will be analyzed, and no additional blood samples will be required.
Detailed description
This prospective observational study will be conducted at Elazig Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation. Patients undergoing total knee arthroplasty will be assigned to two groups based on the anesthesia method used in routine practice: spinal anesthesia or general anesthesia. The primary outcome measure is the Delta Neutrophil Index (DNI), an inflammation marker automatically calculated by hematology analyzers using complete blood count parameters. DNI values will be compared preoperatively and postoperatively between groups. Additional data including age, sex, ASA classification, duration of surgery, hemogram parameters, and perioperative complications will be collected. The sample size calculation indicated that a minimum of 42 patients per group (total 84) are required to detect significant differences in DNI levels with 80% power at a 5% significance level. Statistical analyses will include Kolmogorov-Smirnov test for normality, independent t test or Mann-Whitney U test for between-group comparisons, and paired t test or Wilcoxon test for within-group comparisons. A p-value <0.05 will be considered statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spinal Anesthesia Group | – | Other: Routine Clinical Anesthesia PracticePatients undergoing total knee arthroplasty under spinal anesthesia. The choice of anesthesia is based on clinical decision-making in routine practice. |
| General Anesthesia Group | – | Other: Routine Clinical Anesthesia PracticePatients undergoing total knee arthroplasty under general anesthesia. The choice of anesthesia is based on clinical decision-making in routine practice. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective total knee arthroplasty at Elazig Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation.
Key inclusion criteria (3 listed)
- Patients scheduled for total knee arthroplasty
- Age ≥ 18 years
- ASA physical status classification I-III
Key exclusion criteria (7 listed)
- Active infection
- Hematologic disease (e.g., leukemia, aplastic anemia)
- Autoimmune or chronic inflammatory disease
- Use of corticosteroids or immunosuppressive drugs
- Malignancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine Clinical Anesthesia PracticePatients undergoing total knee arthroplasty will receive either spinal or general anesthesia as determined by routine clinical practice and the attending anesthesiologist's decision. Investigators will not influence the choice of anesthesia method. | Other | General Anesthesia Group, Spinal Anesthesia Group |
Primary outcome
Change in Delta Neutrophil Index (DNI)
Time frame: From baseline (preoperative) to 24 hours postoperative.
Difference in DNI values measured preoperatively and postoperatively in patients undergoing total knee arthroplasty under spinal versus general anesthesia.
5 secondary outcomes
Neutrophil Count
Time frame: Preoperative to 24 hours postoperative.
Perioperative Complications
Time frame: Intraoperative and during hospital stay (up to 7 days).
Operative Time
Time frame: Intraoperative period.
Lymphocyte Count
Time frame: Preoperative to 24 hours postoperative.
Neutrophil-to-Lymphocyte Ratio (NLR)
Time frame: Preoperative to 24 hours postoperative.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2025.
- Background: PubMed 33067685Bozan MB, Yazar FM, Kale IT, Yuzbasioglu MF, Boran OF, Azak Bozan A. Delta Neutrophil Index and Neutrophil-to-Lymphocyte Ratio in the Differentiation of Thyroid Malignancy and Nodular Goiter. World J Surg. 2021 Feb;45(2):507-514. doi: 10.1007/s00268-020-05822-6. Epub 2020 Oct 16.
- Background: PubMed 18715852Nahm CH, Choi JW, Lee J. Delta neutrophil index in automated immature granulocyte counts for assessing disease severity of patients with sepsis. Ann Clin Lab Sci. 2008 Summer;38(3):241-6.
- Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and ReanimationLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the study is single-center, observational, and involves routine clinical laboratory results that are stored only in hospital records.
Related trials for Inflammatory Response in Total Knee Arthroplasty
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sevim Şenol Karataş principal investigator
Elazığ Fethi Sekin City Hospital, Department of Anesthesiology and Reanimation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Response in Total Knee Arthroplasty, run by Elazıg Fethi Sekin Sehir Hastanesi at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Delta Neutrophil Index (DNI) (time frame: From baseline (preoperative) to 24 hours postoperative.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07214558, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2025.