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Completed

NCT Number: NCT06159751

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

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.

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Key information

Conditions

Gonarthrosis Arthritis Blood Protein Disorders Hematologic Diseases Hemic and Lymphatic Diseases Hypoalbuminemia Hypoproteinemia Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases Serum Albumin Low

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ufuk University

Ankara, Çankaya, 06520, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

serum albumin level

Other

serum albumin level in gonarthrosis

Primary outcomes

  1. serum albumin level

    Time frame: 1 month

    serum albumin level

  2. The Aggregate Index of Systemic Inflammation (AISI)

    Time frame: 1 month

    Neutrophil countxPlatelet countxMonocyte count/ Lymphocyte count

  3. Systemic Inflammatory Response Index (SIRI)

    Time frame: 1 month

    Neutrophil countxMonocyte count/ Lymphocyte count

  4. Systemic Immune Inflammation Index (SII)

    Time frame: 1 month

    Platelet countxNeutrophil count/Lymphocyte count

  5. Prognostic Nutrisyonel Index (PNI)

    Time frame: 1 month

    Serum albumin concentration (g/l) + (5xlymphocyte count (thousand/microlitre)

  6. 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

Sponsors and collaborators

Lead sponsor

Ufuk University

Other

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Dec 7, 2023
Registry last updated
Dec 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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