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

NCT ID: NCT06254976

Last Updated: 2024-02-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-06-01

Study Completion Date

2023-12-01

Brief Summary

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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

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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.

Conditions

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Osteoarthritis of Knee Degenerative Osteoarthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

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 Study Purpose

TREATMENT

Blinding Strategy

SINGLE

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

Study Groups

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2 week home exercise program

Joint range of motion exercises, four-way straight leg raises, isotonic quadriceps strengthening, hamstring and quadriceps stretching exercises were given. The exercise program was demonstrated by the same physiotherapist. The patients' exercise compliance was questioned and noted.

Group Type ACTIVE_COMPARATOR

exercise

Intervention Type BEHAVIORAL

2 weeks of home exercise

2 doses of intraarticular PRP application, 1 week apart

2 doses of intra-articular 3 cc LP-PRP were applied to the patients, 1 week apart, from the inferolateral aspect of the patella, in accordance with antisepsis conditions, by a physical medicine and rehabilitation specialist.

Group Type ACTIVE_COMPARATOR

intraarticular knee PRP injections

Intervention Type BIOLOGICAL

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

Interventions

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exercise

2 weeks of home exercise

Intervention Type BEHAVIORAL

intraarticular knee PRP injections

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

Intervention Type BIOLOGICAL

Other Intervention Names

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PRP

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kayseri City Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Havva Talay Çalış

professor doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Havva Talay Çalış, Prof

Role: STUDY_DIRECTOR

Saglik Bilimleri Universitesi

Duygu Gökbelen Bilen

Role: PRINCIPAL_INVESTIGATOR

Saglik Bilimleri Universitesi

Locations

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Health Sciences University, Kayseri Medicine Faculty, Kayseri City Hospital

Kayseri, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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health sciences university

Identifier Type: -

Identifier Source: org_study_id

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