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

Osteoarthritis of Knee Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06254976
• Other study ID #: health sciences university
• Status: Completed
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: February 2024
• Source: Kayseri City Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Osteoarthritis
• Osteoarthritis
• Osteoarthritis of Knee
• Osteoarthritis, Knee

Intervention

Behavioral:
• exercise
2 weeks of home exercise

Biological:
• intraarticular knee PRP injections
2 doses of intra-articular platelet rich plasma (PRP) injection, 1 week apart

Locations

Country	Name	City	State
Turkey	Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital	Kayseri

Sponsors (1)

Lead Sponsor	Collaborator
Kayseri City Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Serum YKL-40 levels	It will be evaluated before and after exercise and before and after PRP. 0-14-28. day	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).
Primary	Change in Serum nesfatin-1 levels	It will be evaluated before and after exercise and before and after PRP. 0-14-28. day	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).
Primary	NRS pain score	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.	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).
Primary	WOMAC score	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.	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).
Primary	6 minutes walking test	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.	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).
Primary	Cartilage thickness measurement with USG	Cartilage thickness measurements (millimeter) were measured in the medial and lateral facets where the cartilage was thickest and averaged with ultrasonography.	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).