Knee OsteoarthritisNCT06946056
Evaluation of the Effect of Biofiller PRP Application on Knee Osteoarthritis
A study testing Biofiller platelet rich plasma in people with Knee Osteoarthritis and Biofiller PRP, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study is to evaluate the effects of biofiller PRP on function, pain level, and femoral cartilage thickness in knee osteoarthritis: a randomized clinical study Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Knee Osteoarthritis, Biofiller PRP, Femoral Cartilage Thickness
- What is being tested?
- Biofiller platelet rich plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 1 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Biofiller PRP on Function, Pain Level, and Femoral Cartilage Thickness in Knee Osteoarthritis: a Randomized Clinical Study
The aim of this study is to evaluate the effects of biofiller PRP on function, pain level, and femoral cartilage thickness in knee osteoarthritis: a randomized clinical study
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
- Being tested
- Biofiller platelet rich plasma
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofiller platelet rich plasmaOther
Biofiller platelet rich plasma Arm Description: 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Biofiller platelet rich plasma |
| 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 . Receives: Other: Biofiller platelet rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline and month 3
Secondary outcomes (1)
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
Measured: Baseline and month 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2025
- Study start1 Jun 2025
- Primary completion1 Jun 2026
- Study completion1 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Banu Ordahan, Necmettin Erbakan University
- Investigators
- BANU ORDAHAN, Principal investigator, Necmettin Erbakan University, Konya, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06946056
- Sponsor's protocol ID
- Büşra Demirtaş
- Status last verified
- Oct 2026
- First submitted
- 9 Apr 2025
- Last updated
- 28 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Biofiller PRP on Function, Pain Level, and Femoral Cartilage Thickness in Knee Osteoarthritis: a Randomized Clinical Study
- ClinicalTrials.gov ID
- NCT06946056
- Acronym / sponsor ID
- Büşra Demirtaş
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 1 Jun 2026 (actual)
- First posted
- 27 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the effects of biofiller PRP on function, pain level, and femoral cartilage thickness in knee osteoarthritis: a randomized clinical study
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biofiller platelet rich plasma | Active comparator | Other: Biofiller platelet rich plasmaTen 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. |
| Platelet rich plasma | Active comparator | Other: Biofiller platelet rich plasmaTen ml of the patient's blood wasdrawn in a syringe . It wascentrifuged firstat 4000 rotations per minute (RPM)for 10 min . |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofiller platelet rich plasmaBiofiller platelet rich plasma Arm Description: 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 platelet rich plasma, Platelet rich plasma |
Primary outcome
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.
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Knee Osteoarthritis
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Single vs Triple Hyaluronic Acid in Knee Osteoarthritis
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BANU ORDAHAN principal investigator
Necmettin Erbakan University, Konya, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofiller platelet rich plasma in people with Knee Osteoarthritis and Biofiller PRP, run by Necmettin Erbakan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) Change from baseline in pain on the VAS at month 3 (time frame: Baseline and month 3). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.