CClinicalTrials.gg
CompletedNCT06946056Updated Sep 23, 2026

Evaluation of the Effect of Biofiller PRP Application on Knee Osteoarthritis

An interventional study of biofiller prp in Knee Osteoarthritis, Biofiller PRP and Femoral Cartilage Thickness, sponsored by Necmettin Erbakan University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 45 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Necmettin Erbakan University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
45 Years to 65 Years
Sex
All
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Study 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.

Read the detailed description

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

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Conditions studied

  • Knee Osteoarthritis
  • Biofiller PRP
  • Femoral Cartilage Thickness
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In context

Osteoarthritis, Knee

3,302 studies on the registry are indexed under Osteoarthritis, Knee; 608 are open to participants now.

This study's enrollment of 60 is below the median of 70 across 2,731 interventional studies indexed under Osteoarthritis, Knee.

Browse Osteoarthritis, Knee studies →

Lead sponsor

Necmettin Erbakan University is the lead sponsor of 198 studies on the registry; 48 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
60 participants (actual)

Study arms

  • Active comparator
    Biofiller platelet rich plasma

    Ten ml of the patient's blood wasdrawn in a syringe . It wascentrifuged firstat 4000 rotations per minute (RPM)for 10 min . The upper part,i.e.,platelet-poor plasma (PPP) was withdrawn in a 5 mL syringe. PRP was incubated in hot incubator at 75 °C for 10 min and then cooled in a refrigerator for 5 min.

    Other: biofiller prp

  • Active comparator
    Platelet rich plasma

    Ten ml of the patient's blood wasdrawn in a syringe . It wascentrifuged firstat 4000 rotations per minute (RPM)for 10 min . The upper part,i.e.,platelet-poor plasma (PPP) was withdrawn in a 5 mL syringe

    Other: biofiller prp

Interventions

  • Otherbiofiller prp

    Ten ml of the patient's blood was drawn in a syringe . It wascentrifuged firstat 4000 rotations per minute (RPM)for 10. 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

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline and month 3

Secondary outcomes

  1. 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.

    Time frame: Baseline and month 3

  2. 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

    Time frame: Baseline and month 3

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Study locations

1 site
  • NEU
    Konya, Turkey (Türkiye)
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06946056
Lead sponsor
Necmettin Erbakan University
Responsible party
Banu Ordahan (professor, Necmettin Erbakan University) — Principal investigator
First posted
Apr 27, 2025
Start date
Jun 1, 2025
Primary completion
Jun 1, 2026
Completion
Jun 1, 2026
Last update
Sep 23, 2026

Study contacts

BANU ORDAHAN
principal investigator · Necmettin Erbakan University, Konya, Turkey

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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