Evaluation of the Effect of Biofiller PRP Application on Knee Osteoarthritis

Not Applicable

Not yet recruiting

• Conditions: Knee Osteoarthritis; Biofiller PRP; Femoral Cartilage Thickness

• Registration Number: NCT06946056
• Lead Sponsor: Necmettin Erbakan University

Brief Summary

The aim of this study is to evaluate the effects of biofiller PRP, on pain, range of motion, quality of life, and femoral cartilage thickness in patients with knee osteoarthritis.

Detailed Description

Patients who are admitted and diagnosed with knee osteoarthritis based on anamnesis, physical examination and imaging methods are included in the study

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-09
• Study First Submitted QC: 2025-04-18
• Last Update Submitted: 2025-04-18
• Study First Posted: 2025-04-27
• Last Update Posted: 2025-04-27
• Study Start: 2025-06-01
• Primary Completion: 2026-04-01
• Study Completion: 2026-06-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1-45-65 years old 2-Diagnosis of knee OA according to ACR clinical and radiological diagnostic criteria 3-Kellgren Lawrence stage II or III 4-Knee pain for at least 6 months 5-Visual analog scale (VAS) score of at least 3 or more

Exclusion Criteria

1 - History of surgery or traumatic injury 2-Inflammatory arthritis 3-History of cancer, bleeding diathesis and psychiatric disease 4-Those who have a disease that limits their participation in exercises (severe chronic obstructive lung disease, severe heart failure, history of cerebrovascular events) 5-Hip and ankle problems 6-Participating in another physical therapy program in the last 3 months 7-History of intra-articular injections in the last 6 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS) Change from baseline in pain on the VAS at month 3	Baseline and month 3	Visual Analog Scale (VAS) is used to measure and monitor the intensity of pain. This is a 10 cm ruler that describes painlessness at one end and the most severe pain at the other. A patient scores his/her pain from 0 to 10.

Secondary Outcome Measures

Name	Time	Method
Western OntarioMacMaster (WOMAC) Change from baseline in pain and physical functions on Western OntarioMacMaster scale at month	Baseline and month 3	It is widely used in studies with knee OA patients. The scale, each question of which is evaluated with a 5-point Likert scale, consists of 24 questions. It is filled by patients. There are pain, physical function and stiffness subscales. Pain subscale is evaluated with five items and is scored between 0-20. The hardness subscale has two items and is scored between 0-8. Function subscale consists of 17 items and is scored between 0-68. A high score indicates poor function, pain or stiffness.
Femoral cartilage thickness Change from baseline in knee joint on the measuring the femoral cartilage thickness at month 3	Baseline and month 3	Femoral cartilage thickness is measured by the same physician by placing the probe axially in the suprapatellar region by ultrasonography while the patient is lying on his back and the knees are in maximum flexion. The distance between the thin hyperechoic line at the synovial cartilage interface and the sharp hyperechoic line at the cartilage-bone interface is defined as cartilage thickness