- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06159751
PROGNOSTIC ROLE OF SERUM ALBUMIN LEVEL IN RADIOLOGICAL PROGRESSION OF GONARTHROSIS: IS IT A BIOMARKER IN ITSELF? A BIOMARKER ASSOCIATED WITH SYSTEMIC INFLAMMATION?
November 28, 2023 updated by: Elzem Bolkan Günaydın, Ufuk University
The aim of our study is to evaluate the prognostic roles of serum albumin level and systemic inflammation-related indices, including and not including serum albumin level, in the radiological progression of gonarthrosis.
In this retrospective study, between 10.01.2017 and 10.01.2022, the data of the patients between the ages of 50-80, who applied to Ufuk University Physical Medicine and Rehabilitation clinic with the complaint of knee pain and met the clinical criteria of the American Rheumatology Association for gonarthrosis (knee osteoarthritis) (knee pain on many days of the previous month, crepitation with active joint movement, morning stiffness lasting ≤ 30 minutes, age ≥38 years, bone enlargement of the knee on examination),and whose knee radiography and blood tests were evaluated at admission were scanned.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
375
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Çankaya
-
Ankara, Çankaya, Turkey, 06520
- Ufuk University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Probability Sample
Study Population
- In this retrospective study, between 10.01.2017 and 10.01.2022, the data of the patients between the ages of 50-80, who applied to Ufuk University Physical Medicine and Rehabilitation clinic with the complaint of knee pain and met the clinical criteria of the American Rheumatology Association for gonarthrosis and whose knee radiography and blood tests were evaluated at admission were scanned.
In order to compare the parameters to be included in the study, the data and blood tests of patients between the ages of 50-80 who applied to Ufuk University Physical Medicine and Rehabilitation clinic between 10.01.2017 and 10.01.2022 for reasons other than knee pain were scanned.
Description
Inclusion Criteria:
- In this retrospective study, between 10.01.2017 and 10.01.2022, the data of the patients between the ages of 50-80, who applied to Ufuk University Physical Medicine and Rehabilitation clinic with the complaint of knee pain and met the clinical criteria of the American Rheumatology Association for gonarthrosis (knee osteoarthritis) (knee pain on many days of the previous month, crepitation with active joint movement, morning stiffness lasting ≤ 30 minutes, age ≥38 years, bone enlargement of the knee on examination),and whose knee radiography and blood tests were evaluated at admission were scanned. In order to compare the parameters to be included in the study, the data and blood tests of patients between the ages of 50-80 who applied to Ufuk University Physical Medicine and Rehabilitation clinic between 10.01.2017 and 10.01.2022 for reasons other than knee pain were scanned.
Exclusion Criteria:
- In the patient and control groups, patients who were younger than 50 years of age, older than 80 years of age, had acute or chronic infection, malignancy, rheumatic disease or systemic diseases that could change the blood test parameters to be evaluated, and patients who were missing one or more of the blood test parameters planned to be evaluated among the data obtained were excluded from the study. In addition, in the patient group, patients who had neurogenic or internal organ problems that could cause pain referred to the knees, who were not required to have a knee X-ray when applying to the outpatient clinic, and who had a history of trauma to the knee area, invasive procedure or surgical intervention within the 6 months before admission to the outpatient clinic, were excluded from the study. In the control group, patients who complained of knee pain in addition to their complaints at admission were excluded from the study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
serum albumin level
Time Frame: 1 month
|
serum albumin level
|
1 month
|
|
The Aggregate Index of Systemic Inflammation (AISI)
Time Frame: 1 month
|
Neutrophil countxPlatelet countxMonocyte count/ Lymphocyte count
|
1 month
|
|
Systemic Inflammatory Response Index (SIRI)
Time Frame: 1 month
|
Neutrophil countxMonocyte count/ Lymphocyte count
|
1 month
|
|
Systemic Immune Inflammation Index (SII)
Time Frame: 1 month
|
Platelet countxNeutrophil count/Lymphocyte count
|
1 month
|
|
Prognostic Nutrisyonel Index (PNI)
Time Frame: 1 month
|
Serum albumin concentration (g/l) + (5xlymphocyte count (thousand/microlitre)
|
1 month
|
|
Modified Systemic Inflammation Score (mSIS)
Time Frame: 1 month
|
Serum albumin concentration <40g/l ve LMR<3.4:
score 2 Serum albumin concentration ≥40 g/l veya LMR≥3.4:
score 1 Serum albumin concentration ≥40 g/l ve LMR≥3.4:
score 0
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2023
Primary Completion (Actual)
March 1, 2023
Study Completion (Actual)
March 1, 2023
Study Registration Dates
First Submitted
November 28, 2023
First Submitted That Met QC Criteria
November 28, 2023
First Posted (Estimated)
December 7, 2023
Study Record Updates
Last Update Posted (Estimated)
December 7, 2023
Last Update Submitted That Met QC Criteria
November 28, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12024861-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gonarthrosis
-
Bezmialem Vakif UniversityCompletedGonarthrosis; Primary | Varus GonarthrosisTurkey
-
Saglik Bilimleri Universitesi Gazi Yasargil Training...CompletedPrimary GonarthrosisTurkey (Türkiye)
-
Bezmialem Vakif UniversityNot yet recruitingKnee Osteoarthritis | Gonarthrosis; Primary | Gonarthrosis | Gonarthrosis; Primary, Bilateral | Knee ArthritisTurkey
-
TOPMEDNatural Sciences and Engineering Research Council, Canada; O3D inc.Terminated
-
Ankara Etlik City HospitalEnrolling by invitationTotal Knee Arthroplasty for GonarthrosisTurkey (Türkiye)
-
Federal University of São PauloNot yet recruiting
-
University Hospital, GhentCompletedTricompartmental GonarthrosisBelgium
-
Bezmialem Vakif UniversityUnknown
-
Nevsehir Haci Bektas Veli UniversityCompletedGonarthrosis; PrimaryTurkey
-
Thammasat UniversityCompletedPrimary Gonarthrosis | Genu Recurvatum
Clinical Trials on serum albumin level
-
Protgen LtdCompleted
-
Second Affiliated Hospital, School of Medicine,...RecruitingOral Mucosal Pressure InjuryChina
-
Institut Paoli-CalmettesUnknownSolid Cancer in a Palliative Situation With AscitesFrance
-
Protgen LtdActive, not recruitingAlzheimer's Disease (AD)China
-
Protgen LtdCompletedHepatic AscitesChina
-
Tianjin Huanhu HospitalNot yet recruitingAcute Ischemic Stroke From Large Vessel Occlusion
-
Sohag UniversityNot yet recruiting
-
Assiut UniversityNot yet recruiting