PROGNOSTIC ROLE OF SERUM ALBUMIN LEVEL IN RADIOLOGICAL PROGRESSION OF GONARTHROSIS: IS IT A BIOMARKER IN ITSELF? A BIOMARKER ASSOCIATED WITH SYSTEMIC INFLAMMATION?

Gonarthrosis Clinical Trial

Official title:

PROGNOSTIC ROLE OF SERUM ALBUMIN LEVEL IN RADIOLOGICAL PROGRESSION OF GONARTHROSIS: IS IT A BIOMARKER IN ITSELF? A BIOMARKER ASSOCIATED WITH SYSTEMIC INFLAMMATION?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06159751
• Other study ID #: 12024861-02
• Status: Completed
• Start date: February 1, 2023
• Est. completion date: March 1, 2023

Study information

• Verified date: November 2023
• Source: Ufuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 375
• Est. completion date: March 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Gonarthrosis
• Inflammation
• Osteoarthritis
• Osteoarthritis, Knee
• Serum Albumin Low

Intervention

Other:
• serum albumin level
serum albumin level in gonarthrosis

Locations

Country	Name	City	State
Turkey	Ufuk University	Ankara	Çankaya

Sponsors (1)

Lead Sponsor	Collaborator
Ufuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum albumin level	serum albumin level	1 month
Primary	The Aggregate Index of Systemic Inflammation (AISI)	Neutrophil countxPlatelet countxMonocyte count/ Lymphocyte count	1 month
Primary	Systemic Inflammatory Response Index (SIRI)	Neutrophil countxMonocyte count/ Lymphocyte count	1 month
Primary	Systemic Immune Inflammation Index (SII)	Platelet countxNeutrophil count/Lymphocyte count	1 month
Primary	Prognostic Nutrisyonel Index (PNI)	Serum albumin concentration (g/l) + (5xlymphocyte count (thousand/microlitre)	1 month
Primary	Modified Systemic Inflammation Score (mSIS)	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