Clinical trial NCT06254976: Serum Nesfatin-1 and Human Cartilage Glycoprotein-39 Levels in Knee Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoarthritis of Knee
Degenerative Osteoarthritis
Lead sponsor: Kayseri City Hospital
Sponsor class: OTHER_GOV
First posted: 2024-02-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Serum YKL-40 levels
timeFrame: 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).
measure: Change in Serum nesfatin-1 levels
timeFrame: 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).
measure: NRS pain score
timeFrame: 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).
measure: WOMAC score
timeFrame: 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).
measure: 6 minutes walking test
timeFrame: 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).
measure: Cartilage thickness measurement with USG
timeFrame: 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).
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital
Study officials:
affiliation: Saglik Bilimleri Universitesi
name: Havva Talay Çalış, Prof
role: STUDY_DIRECTOR
affiliation: Saglik Bilimleri Universitesi
name: Duygu Gökbelen Bilen
role: PRINCIPAL_INVESTIGATOR
References: