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

NCT06159751 | Completed

• 1 other identifier: 12024861-02
• Study Type: observational
• Target: 375
• Locations: 1 country
• Sites: 1

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.

Conditions

Gonarthrosis; Serum Albumin Low

Outcome Measures

Primary Outcomes (6)

• serum albumin level

  serum albumin level

  1 month

• The Aggregate Index of Systemic Inflammation (AISI)

  Neutrophil countxPlatelet countxMonocyte count/ Lymphocyte count

  1 month

• Systemic Inflammatory Response Index (SIRI)

  Neutrophil countxMonocyte count/ Lymphocyte count

  1 month

• Systemic Immune Inflammation Index (SII)

  Platelet countxNeutrophil count/Lymphocyte count

  1 month

• Prognostic Nutrisyonel Index (PNI)

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

  1 month

• 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

Interventions

serum albumin level OTHER

serum albumin level in gonarthrosis

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ufuk University: lead

Study Sites (1)

Ufuk University

Ankara, Çankaya, 06520, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Hypoalbuminemia

Interventions

Serum Albumin

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Hypoproteinemia; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Albumins; Proteins; Amino Acids, Peptides, and Proteins; Blood Proteins

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 7, 2023
• Study Start: February 1, 2023
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)