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Serum Nesfatin-1 and Human Cartilage Glycoprotein-39 Levels in Knee Osteoarthritis

Correlation Between Serum Nesfatin-1 and Human Cartilage Glycoprotein-39 (YKL-40) Levels and Ultrasonographic Findings in Patients With Knee Osteoarthritis, Effect of Platelet Rich Plasma Treatment on Serum YKL-40 and Nesfatin-1 Levels

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06254976
Enrollment
30
Registered
2024-02-12
Start date
2022-06-01
Completion date
2023-12-01
Last updated
2024-02-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Osteoarthritis, Osteoarthritis of Knee

Brief summary

In this study, our objective was to assess the correlation between serum human cartilage glycoprotein-39 (YKL-40) and nesfatin-1 values, the patient's clinical condition, ultrasonographic cartilage thickness measurements, and the response to PRP treatment in knee osteoarthritis (OA)

Detailed description

The objective of this study is to assess the correlation between serum human cartilage glycoprotein-39 (YKL-40) and nesfatin-1 values, clinical condition, ultrasonographic cartilage thickness measurements, and response to PRP treatment in Knee Osteoarthritis (OA). Thirty patients diagnosed with grade 2 and 3 knee osteoarthritis (OA) according to American College of Rheumatology (ACR) diagnostic criteria, and scheduled for leukocyte-poor platelet-rich plasma (LP-PRP) injections, were enrolled in the study. Patients were assessed at three time points: before treatment (day 0), after exercise treatment (day 14), and after two doses of LP-PRP treatment combined with exercise treatment once a week (day 28). The evaluation included the Numeric Rating Scale (NRS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), cartilage thickness measurement by ultrasonography (USG), 6-minute walk test (6MWT) parameters, and measurements of serum YKL-40 and nesfatin-1 levels.

Interventions

BEHAVIORALexercise

2 weeks of home exercise

BIOLOGICALintraarticular knee PRP injections

2 doses of intra-articular platelet rich plasma (PRP) injection, 1 week apart

Sponsors

Kayseri City Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The evaluations were conducted by a physical therapy and rehabilitation specialist who was blinded to the patient's treatment protocol, ensuring unbiased assessments.

Intervention model description

Thirty patients were evaluated at three different time points: before treatment (day 0), after exercise treatment (day 14), and after two doses of LP-PRP treatment combined with exercise treatment once a week (day 28). The assessment included the Numeric Rating Scale (NRS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), cartilage thickness measurement by ultrasonography (USG), 6-minute walk test (6MWT) parameters, and measurements of serum YKL-40 and nesfatin-1 levels.

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Having patient consent, * Having stage 2-3 knee osteoarthritis according to the Kellgren-Lawrence scale, * Being diagnosed with knee osteoarthritis according to ACR (American college of Rheumatology), * Being over the age of 18 - under the age of 75, * Having NRS 4 and above

Exclusion criteria

* Those who have had knee surgery before, * Those who have had any local injections such as physical therapy, intra-articular steroid or hyaluronic acid injection in the knee area in the last 3 months, * Malignancies, * Those with local infection, wound, scar in the relevant area, * Infections, Hepatitis, Immunosuppression, * Inflammatory arthropathies, * Uncontrolled Hypertension, uncontrolled Diabetes Mellitus, decompensated heart failure, coronary artery disease, asthma * Recent trauma, * Epileptic patients, * Pregnant women, * Corticosteroid use, * Avascular necrosis * Anemia, bleeding coagulation disorder

Design outcomes

Primary

MeasureTime frameDescription
Change in Serum YKL-40 levelsbefore treatment (day 0), after exercise treatment (day 14), and after two doses of LP-PRP treatment combined with exercise treatment once a week (day 28).It will be evaluated before and after exercise and before and after PRP. 0-14-28. day
Change in Serum nesfatin-1 levelsbefore treatment (day 0), after exercise treatment (day 14), and after two doses of LP-PRP treatment combined with exercise treatment once a week (day 28).It will be evaluated before and after exercise and before and after PRP. 0-14-28. day
NRS pain scorebefore treatment (day 0), after exercise treatment (day 14), and after two doses of LP-PRP treatment combined with exercise treatment once a week (day 28).Numerical Rating Scale (NRS), is basically any scale that renders a quantitative symbolization of an attribute. This type of scale is used by presenting the respondent with an ordered set from which to choose, for example, 1 to 10, coupled with anchors.The numeric rating scale (NRS) is a pain screening tool, commonly used to assess pain severity at that moment in time using a 0-10 scale, with zero meaning no pain and 10 meaning the worst pain imaginable.
WOMAC scorebefore treatment (day 0), after exercise treatment (day 14), and after two doses of LP-PRP treatment combined with exercise treatment once a week (day 28).It is a disease-specific measurement for knee and hip osteoarthritis. WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) is a personalized index with 5 questions for pain, 2 for stiffness, and 17 questions for questioning daily activities. It has different scores from 0 to 4 (0: none, 1: mild, 2: moderate, 3: severe, 4: very severe). Scale lengths of subheadings; pain=20, stiffness=8, physical function=68. Turkish validation is available . A high score indicates poor health.
6 minutes walking testbefore treatment (day 0), after exercise treatment (day 14), and after two doses of LP-PRP treatment combined with exercise treatment once a week (day 28).It is a test used to reveal submaximal functional performance. The test should be performed in a closed, quiet environment of at least 30 meters, marked every 3 meters, and in a straight corridor. The patient should be warned to wear comfortable clothes and suitable shoes. The turning points during walking should be marked with the help of a cone and the patient should be asked to go around this cone. The test is terminated by calculating the total distance walked in six minutes.A low score indicates poor health.
Cartilage thickness measurement with USGbefore treatment (day 0), after exercise treatment (day 14), and after two doses of LP-PRP treatment combined with exercise treatment once a week (day 28).Cartilage thickness measurements (millimeter) were measured in the medial and lateral facets where the cartilage was thickest and averaged with ultrasonography.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026