Skip to main content
OpenTrials
Completed

NCT Number: NCT06254976

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

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)

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Osteoarthritis of Knee Arthritis Degenerative Osteoarthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital

Kayseri, 38080, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Exercise

Behavioral

2 weeks of home exercise

intraarticular knee PRP injections

Biological

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

Other names: PRP

Primary outcomes

  1. Change in Serum YKL-40 levels

    Time frame: 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).

    It will be evaluated before and after exercise and before and after PRP. 0-14-28. day

  2. Change in Serum nesfatin-1 levels

    Time frame: 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).

    It will be evaluated before and after exercise and before and after PRP. 0-14-28. day

  3. NRS pain score

    Time frame: 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).

    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.

  4. WOMAC score

    Time frame: 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).

    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.

  5. 6 minutes walking test

    Time frame: 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).

    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.

  6. Cartilage thickness measurement with USG

    Time frame: 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).

    Cartilage thickness measurements (millimeter) were measured in the medial and lateral facets where the cartilage was thickest and averaged with ultrasonography.

Sponsors and collaborators

Lead sponsor

Kayseri City Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 12, 2024
Registry last updated
Feb 23, 2024

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.