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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06254976
Other study ID # health sciences university
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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).
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