Knee ArthropathyNCT03148951
Effect of NLR and MPV on Early Postoperative Outcome in Lower Extremity Arthroplasty Operations
An observational study of Knee Arthropathy, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
In the planned study the investigators want to evaluate the relation between postoperative complications and minor/ major morbidities, mortality and Mean Platelet Volume (MPV) and Neutrophil/ lymphocyte (N/L) ratio. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Knee Arthropathy
- How many people
- 754 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jun 2017to 31 Jan 2018
- How long will I take part?
- 1 Day
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consecutive patients undergoing knee arthroplasty in 3 years period with general or spinal anesthesia.
Who may be able to join
- knee arthroplasty patients with general or spinal anesthesia.
Who cannot join
- patients not giving consent
- reoperations
- patients having inflammatory disease
- infection in the knee
- sepsis
- bleeding disorders
Show all 14Show fewer
- hematologic diseases,
- using steroids.
- trauma
- fracture patients,
- bilateral knee prothesis
- combined surgery procedures
- patients needing perioperative transfusions
- uncooperative patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Neutrophil /Lymphocyte Ratio (NLR) and Mean Platelet Volume (MPV) on Early Postoperative Outcome in Lower Extremity Arthroplasty Operations
In the planned study the investigators want to evaluate the relation between postoperative complications and minor/ major morbidities, mortality and Mean Platelet Volume (MPV) and Neutrophil/ lymphocyte (N/L) ratio.
Read the detailed description
- In this study the investigators aim to determine the relation between the MPV and N/L ratio and the incidence of postoperative adverse events and complications in patients undergoing knee arthroplasty.
- In this study only the laboratory tests that are routinely used for the operative patients are going to be used and no extra tests will be performed. The study will begin after the postoperative blood samples are collected for routine laboratory measurements. The patients will be allocated to 4 groups according to the type of anesthesia and VAS scores. Preoperative and postoperative peripheral blood total whole blood MPV and N/L ratio and 1st 6th 12th ve 24th hours VAS scores and complications, morbidities and mortality will be recorded. The patients will receive analgesics according to the routine practice in the ward and the doses of analgesics given will be recorded at 1st 6th 12th ve 24the hours wil be recorded.
- Statistical analysis: the numerical variables will be analyzed tested with Kolmogorov-Smirnov test for normality. For the parametric variables that are normally distributed t-test will be used for the comparison between groups. For the parametric variables that are not normally distributed Mann Whitney-U test will be used. All the categorical variables will be evaluated with q- square tests. A p value < 0.05 will be determined as statistically significant.
- Conditions
- Knee Arthropathy
- Keywords
- MPV, NLR, Postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Group 1: patients receiving general anesthesia and having a postoperative pain VAS score equal to or below 50 at 1st, 6th, 12th nd 24th hours the pain sores will be evaluated at 4 time intervals and so the number of patients in every group may change at every time interval. | |
| Group 2 | Group 2: patients receiving general anesthesia and having a postoperative pain VAS score equal to or above 60 at 1st, 6th, 12th nd 24th hours the pain sores will be evaluated at 4 time intervals and so the number of patients in every group may change at every time interval. | |
| Group 3 | Group 3: patients receiving regional (spinal) anesthesia and having a postoperative pain VAS score equal to or below 50 at 1st, 6th, 12th nd 24th hours the pain sores will be evaluated at 4 time intervals and so the number of patients in every group may change at every time interval. | |
| Group 4 | Group 4: patients receiving spinal anesthesia and having a postoperative pain VAS score equal to or above 60 at 1st, 6th, 12th nd 24th hours the pain sores will be evaluated at 4 time intervals and so the number of patients in every group may change at every time interval. |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative VAS (visual analogue scale) score
postoperative visual analog scale score for pain evaluation 0,10,20,30,40,50,60,70,80,90,100)
Measured: VAS score at postoperative twenty-forth hours will be evaluated
Secondary outcomes (2)
analgesic drugs
analgesic drugs given according to the routine practice in the ward
Measured: total dose of analgesic drugs required at twenty four hours will be evaluated
postoperative major morbidities
postoperative Myocardial Infarction (MI), Acute Kidney Injury(AKI), and Cerebrovascular Events (CVO)s.
Measured: at postoperative first, sixth, twelfth and twenty-forth hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2017
- Study start28 Jun 2017
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee ArthropathyStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- 754 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İlker Onguc Aycan, Akdeniz University
- Investigators
- Ilker o Aycan, asso prof, Principal investigator, Akdeniz University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03148951
- Sponsor's protocol ID
- MANLOP
- Status last verified
- Jan 2023
- First submitted
- 2 May 2017
- Last updated
- 13 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Neutrophil /Lymphocyte Ratio (NLR) and Mean Platelet Volume (MPV) on Early Postoperative Outcome in Lower Extremity Arthroplasty Operations
- ClinicalTrials.gov ID
- NCT03148951
- Acronym / sponsor ID
- MANLOP
- Conditions
- Knee Arthropathy
- Keywords
- MPV, NLR, Postoperative pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 754 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 11 May 2017 (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.
In the planned study the investigators want to evaluate the relation between postoperative complications and minor/ major morbidities, mortality and Mean Platelet Volume (MPV) and Neutrophil/ lymphocyte (N/L) ratio.
Detailed description
- In this study the investigators aim to determine the relation between the MPV and N/L ratio and the incidence of postoperative adverse events and complications in patients undergoing knee arthroplasty.
- In this study only the laboratory tests that are routinely used for the operative patients are going to be used and no extra tests will be performed. The study will begin after the postoperative blood samples are collected for routine laboratory measurements. The patients will be allocated to 4 groups according to the type of anesthesia and VAS scores. Preoperative and postoperative peripheral blood total whole blood MPV and N/L ratio and 1st 6th 12th ve 24th hours VAS scores and complications, morbidities and mortality will be recorded. The patients will receive analgesics according to the routine practice in the ward and the doses of analgesics given will be recorded at 1st 6th 12th ve 24the hours wil be recorded.
- Statistical analysis: the numerical variables will be analyzed tested with Kolmogorov-Smirnov test for normality. For the parametric variables that are normally distributed t-test will be used for the comparison between groups. For the parametric variables that are not normally distributed Mann Whitney-U test will be used. All the categorical variables will be evaluated with q- square tests. A p value < 0.05 will be determined as statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Group 1: patients receiving general anesthesia and having a postoperative pain VAS score equal to or below 50 at 1st, 6th, 12th nd 24th hours the pain sores will be evaluated at 4 time intervals and so the number of patients in every group may change at every time interval. |
| Group 2 | – | –Group 2: patients receiving general anesthesia and having a postoperative pain VAS score equal to or above 60 at 1st, 6th, 12th nd 24th hours the pain sores will be evaluated at 4 time intervals and so the number of patients in every group may change at every time interval. |
| Group 3 | – | –Group 3: patients receiving regional (spinal) anesthesia and having a postoperative pain VAS score equal to or below 50 at 1st, 6th, 12th nd 24th hours the pain sores will be evaluated at 4 time intervals and so the number of patients in every group may change at every time interval. |
| Group 4 | – | –Group 4: patients receiving spinal anesthesia and having a postoperative pain VAS score equal to or above 60 at 1st, 6th, 12th nd 24th hours the pain sores will be evaluated at 4 time intervals and so the number of patients in every group may change at every time interval. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive patients undergoing knee arthroplasty in 3 years period with general or spinal anesthesia.
Key inclusion criteria (1 listed)
- knee arthroplasty patients with general or spinal anesthesia.
Key exclusion criteria (14 listed)
- patients not giving consent
- reoperations
- patients having inflammatory disease
- infection in the knee
- sepsis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postoperative VAS (visual analogue scale) score
Time frame: VAS score at postoperative twenty-forth hours will be evaluated
postoperative visual analog scale score for pain evaluation 0,10,20,30,40,50,60,70,80,90,100)
2 secondary outcomes
analgesic drugs
Time frame: total dose of analgesic drugs required at twenty four hours will be evaluated
postoperative major morbidities
Time frame: at postoperative first, sixth, twelfth and twenty-forth hours
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 13 Jan 2023.
- The role of mean platelet volume in patients with non-specific abdominal pain in an emergency departmentLink provided by the sponsor.
- Neutrophil/Lymphocyte Ratio as a Predictor of In-Hospital Major Adverse Cardiac Events, New-Onset Atrial Fibrillation, and No-Reflow Phenomenon in Patients with ST Elevation Myocardial InfarctionLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Ilker o Aycan, asso prof principal investigator
Akdeniz University Hospital
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 Knee Arthropathy, run by Akdeniz University 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 1 inclusion and 14 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 13 Jan 2023. 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?
postoperative VAS (visual analogue scale) score (time frame: VAS score at postoperative twenty-forth hours will be evaluated). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jan 2023.