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?
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?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gonarthrosis
Serum Albumin Low
Lead sponsor: Ufuk University
Sponsor class: OTHER
First posted: 2023-12-07
Enrollment: 375
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: RETROSPECTIVE
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.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: serum albumin level
timeFrame: 1 month
measure: The Aggregate Index of Systemic Inflammation (AISI)
timeFrame: 1 month
measure: Systemic Inflammatory Response Index (SIRI)
timeFrame: 1 month
measure: Systemic Immune Inflammation Index (SII)
timeFrame: 1 month
measure: Prognostic Nutrisyonel Index (PNI)
timeFrame: 1 month
measure: Modified Systemic Inflammation Score (mSIS)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ufuk University
state: Çankaya
Study officials:
References: