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NCT Number: NCT06946056

Evaluation of the Effect of Biofiller PRP Application on 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.

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Key information

Conditions

Knee Osteoarthritis Arthritis Biofiller PRP Femoral Cartilage Thickness Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NEU

Konya, Turkey (Türkiye)

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biofiller prp

Other

Ten ml of the patient's blood was drawn in a syringe pre-filled with 1 mLacid citrate (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) waswithdrawn in a 5 mL syringe. PPP wasincubated in hot incubator at 75 °C for 10 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

Primary outcomes

  1. Visual Analog Scale (VAS) Change from baseline in pain on the VAS at month 3

    Time frame: 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 outcomes

  1. Western OntarioMacMaster (WOMAC) Change from baseline in pain and physical functions on Western OntarioMacMaster scale at month

    Time frame: 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.

  2. Femoral cartilage thickness Change from baseline in knee joint on the measuring the femoral cartilage thickness at month 3

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Necmettin Erbakan University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 27, 2025
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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