Evaluation of the Effect of Biofiller PRP Application on Knee Osteoarthritis

NCT06946056 | Completed

• 1 other identifier: Büşra Demirtaş
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Biofiller PRP; Femoral Cartilage Thickness

Outcome Measures

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.

  Baseline and month 3

Secondary Outcomes (2)

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

  Baseline and month 3

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

  Baseline and month 3

Study Arms (2)

Biofiller platelet rich plasma

ACTIVE COMPARATOR

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 The upper part,i.e.,platelet-poor plasma (PPP) was withdrawn in a 5 mL syringe.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

Platelet rich plasma

ACTIVE COMPARATOR

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 The upper part,i.e.,platelet-poor plasma (PPP) was withdrawn in a 5 mL syringe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

biofiller prp OTHER

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

Biofiller platelet rich plasma; Platelet rich plasma

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Necmettin Erbakan University: lead

Study Sites (1)

NEU

Konya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• BANU ORDAHAN

  Necmettin Erbakan University, Konya, Turkey

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: April 27, 2025
• Study Start: June 1, 2025
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: September 23, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)