Evaluation of the Effect of Biofiller PRP Application on Knee Osteoarthritis

Evaluation of the Effect of Biofiller PRP Application on Range of Motion, Pain, Quality of Life and Femoral Cartilage Thickness in Knee Osteoarthritis

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Knee Osteoarthritis; Biofiller PRP; Femoral Cartilage Thickness
• Intervention / Treatment: Other: biofiller prp

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Konya, Turkey (Türkiye)
    • NEU

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Biofiller platelet rich plasma; Ten ml of the patient's blood wasdrawn in a syringe pre-filled with 1 mLacid citrate dextrose(anticoagulant). It wascentrifuged firstat 4000 rotations per minute (RPM)for 15 min and thenat 1500 RPM for 5 min. The upper part,i.e.,platelet-poor plasma (PPP) was withdrawn in a 5 mL syringe. PRP was incubated in hot incubator at 100a °C for 5 min and then cooled in a refrigerator for 5 min.	Other: biofiller prp; Ten ml of the patient's blood was drawn in a syringe pre-filled with 1 mLacid citrate dextrose(anticoagulant). It wascentrifuged firstat 3500 rotations per minute (RPM)for 15 min and thenat 1500 RPM for 5 min. The upper part,i.e.,platelet-poor plasma (PPP) waswithdrawn in a 5 mL syringe. PPP wasincubated in hot water at 100a °C for 5 min and then cooled in a refrigerator for 5 min.The PRP injection was performed in a standardized manner and injected into the IA surface of the affected knee joint
Active Comparator: Platelet rich plasma; Ten ml of the patient's blood wasdrawn in a syringe pre-filled with 1 mLacid citrate dextrose(anticoagulant). It wascentrifuged firstat 4000 rotations per minute (RPM)for 15 min and thenat 1500 RPM for 5 min. The upper part,i.e.,platelet-poor plasma (PPP) was withdrawn in a 5 mL syringe	Other: biofiller prp; Ten ml of the patient's blood was drawn in a syringe pre-filled with 1 mLacid citrate dextrose(anticoagulant). It wascentrifuged firstat 3500 rotations per minute (RPM)for 15 min and thenat 1500 RPM for 5 min. The upper part,i.e.,platelet-poor plasma (PPP) waswithdrawn in a 5 mL syringe. PPP wasincubated in hot water at 100a °C for 5 min and then cooled in a refrigerator for 5 min.The PRP injection was performed in a standardized manner and injected into the IA surface of the affected knee joint

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS) Change from baseline in pain on the VAS at 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.	Baseline and month 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Femoral cartilage thickness Change from baseline in knee joint on the measuring the femoral cartilage thickness at 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	Baseline and month 3
Western OntarioMacMaster (WOMAC) Change from baseline in pain and physical functions on Western OntarioMacMaster scale at month	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.	Baseline and month 3

Collaborators and Investigators

• Sponsor: Necmettin Erbakan University
• Investigators: Principal Investigator: BANU ORDAHAN, Necmettin Erbakan University, Konya, Turkey

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: April 9, 2025
• First Submitted That Met QC Criteria: April 18, 2025
• First Posted (Actual): April 27, 2025

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 22, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Büşra Demirtaş

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No