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CompletedNCT06159751Updated Dec 7, 2023

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

An observational study in Gonarthrosis and Serum Albumin Low, sponsored by Ufuk University. Completed at 1 site in Turkey. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-07.

Sponsored by Ufuk University · Observational

Study type
Observational
Model
Other
Time perspective
Retrospective
Enrollment
375
Ages
50 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Gonarthrosis
  • Serum Albumin Low
03

In context

Osteoarthritis, Knee

3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.

This study's enrollment of 375 is above the median of 100 across 472 observational studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Ufuk University is the lead sponsor of 39 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
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.

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

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.
05

Study design

Observational model
Other
Time perspective
Retrospective
Enrollment
375 participants (actual)
Patient registry
No

Interventions

  • Otherserum albumin level

    serum albumin level in gonarthrosis

06

What researchers measure

Primary outcomes

  1. serum albumin level

    serum albumin level

    Time frame: 1 month

  2. The Aggregate Index of Systemic Inflammation (AISI)

    Neutrophil countxPlatelet countxMonocyte count/ Lymphocyte count

    Time frame: 1 month

  3. Systemic Inflammatory Response Index (SIRI)

    Neutrophil countxMonocyte count/ Lymphocyte count

    Time frame: 1 month

  4. Systemic Immune Inflammation Index (SII)

    Platelet countxNeutrophil count/Lymphocyte count

    Time frame: 1 month

  5. Prognostic Nutrisyonel Index (PNI)

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

    Time frame: 1 month

  6. 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

    Time frame: 1 month

07

Study locations

1 site
  • Ufuk University
    Ankara, Çankaya 06520, Turkey
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06159751
Lead sponsor
Ufuk University
Responsible party
Elzem Bolkan Günaydın (MD, Ufuk University) — Principal investigator
First posted
Dec 7, 2023
Start date
Feb 1, 2023
Primary completion
Mar 1, 2023
Completion
Mar 1, 2023
Last update
Dec 7, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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