Knee OsteoarthritisNCT07784907
Efficacy of Platelet-Rich Plasma Combined With Hyaluronic Acid in Knee Osteoarthritis
A study testing Hyaluronic Acid (HA) and Platelet rich plasma (PRP) and Hyaluronic Acid (HA) in people with Knee Osteoarthritis and Knee Osteoarthritis (Knee OA), run by Implai Sp z o.o at 1 site in Poland.
Trial summary
This prospective, randomized, open-label, single-centre post-market clinical follow-up (PMCF) study evaluates the clinical performance and safety of a single intra-articular injection of hyaluronic acid (HA) combined with autologous platelet-rich plasma (PRP) compared with a single intra-articular injection of HA… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Knee Osteoarthritis, Knee Osteoarthritis (Knee OA), Knee Osteoarthritis (OA)
- What is being tested?
- Hyaluronic Acid (HA) and Platelet rich plasma (PRP) and Hyaluronic Acid (HA)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 20 Jul 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Knee osteoarthritis meeting American College of Rheumatology (ACR) criteria
- Kellgren-Lawrence radiographic grade II or III
- Pain intensity in the study knee NRS >= 4 and in the contralateral knee NRS <= 2
- Written informed consent
Who cannot join
- BMI >= 40 kg/m2
- Surgery of the same or contralateral knee within the previous year
- Intra-articular corticosteroid injection into the study joint within 3 months, or hyaluronic acid, platelet-rich plasma or other intra-articular injection therapy within 6 months before enrolment
- Systemic corticosteroid use within 2 weeks
- Systemic inflammatory or autoimmune disease with joint involvement (rheumatoid arthritis, spondyloarthropathy, systemic lupus erythematosus, etc.)
- Oral corticosteroid treatment
- Deep vein thrombosis
- Pregnancy or breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Przychodnia Specjalistyczna Lancet
Chełm, Lublin Voivodeship, 22-100
Jaromir Jarecki, DSc, +48 82 575 05 75, jaromirj@interia.pl
Jaromir Jarecki, DSc
About this study
Official title: Effect of Adding Platelet-Rich Plasma to Hyaluronic Acid on Outcomes of Injection Therapy for Knee Osteoarthritis: A Prospective, Randomized Comparative Study
This prospective, randomized, open-label, single-centre post-market clinical follow-up (PMCF) study evaluates the clinical performance and safety of a single intra-articular injection of hyaluronic acid (HA) combined with autologous platelet-rich plasma (PRP) compared with a single intra-articular injection of HA alone in adults with symptomatic knee osteoarthritis (Kellgren-Lawrence grade II or III).
Knee osteoarthritis is a chronic degenerative joint disease associated with pain, functional limitations, and reduced quality of life. Hyaluronic acid is widely used as viscosupplementation therapy, while platelet-rich plasma provides autologous growth factors that may contribute to the modulation of inflammatory processes and tissue healing. The combination of HA and PRP may provide complementary effects and may offer additional clinical benefit compared with HA alone.
Read more
A total of 50 participants will be randomized in a 1:1 ratio to receive either a single intra-articular injection of 3.8 mL HA combined with 1 mL autologous PRP or a single intra-articular injection of 4.8 mL HA. Participants will be followed for 18 months.
The primary endpoint is the between-group difference in the change in knee pain, measured using the Numeric Rating Scale (NRS), from baseline to Month 6. Secondary outcomes include changes in pain intensity, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Knee Injury and Osteoarthritis Outcome Score (KOOS), quality-of-life measures, and safety assessments throughout the follow-up period.
Both medical devices are CE-marked and are used for their intended purpose. The study is conducted as a PMCF investigation in accordance with Regulation (EU) 2017/745 (MDR).
- Conditions
- Knee Osteoarthritis, Knee Osteoarthritis (Knee OA), Knee Osteoarthritis (OA), Osteoarthritis (OA) of the Knee
- Being tested
- Hyaluronic Acid (HA) and Platelet rich plasma (PRP), Hyaluronic Acid (HA)
- Keywords
- hyaluronic acid, PRP, HA, intra-articular injection, Single intra-articular injection, knee osteoarthritis, viscosupplementation, Hyaluronic acid and platelet-rich plasma
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic Acid (HA) and Platelet rich plasma (PRP)Device
Procedure kit enabling preparation of autologous platelet-rich plasma (PRP) from the participant's venous blood and intra-articular administration combined with sodium hyaluronate. The procedure includes preparation of PRP using a separation device and injection of a total volume of 4.8 mL consisting of 3.8 mL of 2.5% sodium hyaluronate and 1 mL of autologous PRP.
Hyaluronic Acid (HA)Device
Pre-filled syringe containing 4.8 mL of sterile, nonpyrogenic hyaluronic acid gel for intra-articular injection. The product contains sodium hyaluronate at a concentration of 25 mg/mL (total dose: 120 mg), produced by bacterial fermentation and of non-animal origin.
| Study group | Role | What they receive |
|---|---|---|
| Hyaluronic acid with autologous plateletrich plasma | Experimental | Single intra-articular knee injection of 3.8 mL hyaluronic acid combined with 1 mL autologous platelet-rich plasma (PRP), prepared from 13.5 mL of the participant's venous blood using the PRP separation device (total injection volume: 4.8 mL). Receives: Device: Hyaluronic Acid (HA) and Platelet rich plasma (PRP) |
| Hyaluronic acid | Active comparator | Single intra-articular knee injection of 4.8 mL hyaluronic acid gel containing sodium hyaluronate (25 mg/mL; total dose: 120 mg). Receives: Device: Hyaluronic Acid (HA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in knee pain intensity on the Numeric Rating Scale (NRS)
The Numeric Rating Scale (NRS) for pain is an 11-point single-item scale on which the participant rates knee pain intensity over the past week from 0 (no pain) to 10 (worst imaginable pain). The outcome is the between-group difference in change from baseline; a greater decrease indicates greater improvement.
Measured: Baseline to 6 months
Secondary outcomes (6)
Change in knee pain intensity as measured by the Numeric Rating Scale (NRS) at additional time points
The Numeric Rating Scale (NRS) for pain ranges from 0 (no pain) to 10 (worst imaginable pain). Change from baseline is reported; a decrease indicates improvement.
Measured: Baseline, 1, 3, 12 and 18 months
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores
The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) consists of three subscales: Pain, Stiffness, and Physical Function. The total WOMAC score ranges from 0 to 96, with higher scores indicating worse pain, stiffness, and physical function. The Pain subscale ranges from 0 to 20, the Stiffness subscale from 0 to 8, and the Physical Function subscale from 0 to 68. Change from baseline will be assessed for the total WOMAC score and each subscale score. A decrease in score indicates improvement.
Measured: Baseline, 1, 3, 6, 12 and 18 months
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) subscale scores
The Knee Injury and Osteoarthritis Outcome Score (KOOS) consists of five subscales: Symptoms, Pain, Activities of Daily Living, Sport and Recreation, and Knee-related Quality of Life. Each subscale is normalised to a 0-100 scale, where 0 indicates extreme knee problems and 100 indicates no knee problems. Change from baseline will be assessed for each KOOS subscale; an increase in score indicates improvement.
Measured: Baseline to 18 months
Number of participants with at least one treatment-emergent adverse event (AE)
Number of participants experiencing at least one adverse event (AE) of any grade after the study injection, as recorded at every study visit.
Measured: Baseline to 18 months
Number of treatment-emergent adverse events (AEs)
Total count of adverse events (AEs) reported after the study injection, summarised by event type.
Measured: Baseline to 18 months]
Number of participants discontinuing the study due to an adverse event (AE)
Number of participants who did not complete the study because of an adverse event (AE).
Measured: Baseline to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start20 Jul 2026
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
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.
- 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
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Implai Sp z o.o
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jaromir Jarecki, DSc, Principal investigator, Przychodnia Specjalistyczna Lancet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07784907
- Sponsor's protocol ID
- 2.0 17.02.2026
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 25 Aug 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 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Platelet-Rich Plasma to Hyaluronic Acid on Outcomes of Injection Therapy for Knee Osteoarthritis: A Prospective, Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT07784907
- Acronym / sponsor ID
- 2.0 17.02.2026
- Conditions
- Knee Osteoarthritis, Knee Osteoarthritis (Knee OA), Knee Osteoarthritis (OA), Osteoarthritis (OA) of the Knee
- Keywords
- hyaluronic acid, PRP, HA, intra-articular injection, Single intra-articular injection, knee osteoarthritis, viscosupplementation, Hyaluronic acid and platelet-rich plasma
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Implai Sp z o.oIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 25 Aug 2026 (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.
This prospective, randomized, open-label, single-centre post-market clinical follow-up (PMCF) study evaluates the clinical performance and safety of a single intra-articular injection of hyaluronic acid (HA) combined with autologous platelet-rich plasma (PRP) compared with a single intra-articular injection of HA alone in adults with symptomatic knee osteoarthritis (Kellgren-Lawrence grade II or III).
Knee osteoarthritis is a chronic degenerative joint disease associated with pain, functional limitations, and reduced quality of life. Hyaluronic acid is widely used as viscosupplementation therapy, while platelet-rich plasma provides autologous growth factors that may contribute to the modulation of inflammatory processes and tissue healing. The combination of HA and PRP may provide complementary effects and may offer additional clinical benefit compared with HA alone.
A total of 50 participants will be randomized in a 1:1 ratio to receive either a single intra-articular injection of 3.8 mL HA combined with 1 mL autologous PRP or a single intra-articular injection of 4.8 mL HA. Participants will be followed for 18 months.
The primary endpoint is the between-group difference in the change in knee pain, measured using the Numeric Rating Scale (NRS), from baseline to Month 6. Secondary outcomes include changes in pain intensity, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Knee Injury and Osteoarthritis Outcome Score (KOOS), quality-of-life measures, and safety assessments throughout the follow-up period.
Both medical devices are CE-marked and are used for their intended purpose. The study is conducted as a PMCF investigation in accordance with Regulation (EU) 2017/745 (MDR).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hyaluronic acid with autologous plateletrich plasma | Experimental | Device: Hyaluronic Acid (HA) and Platelet rich plasma (PRP)Single intra-articular knee injection of 3.8 mL hyaluronic acid combined with 1 mL autologous platelet-rich plasma (PRP), prepared from 13.5 mL of the participant's venous blood using the PRP separation device (total injection volume: 4.8 mL). |
| Hyaluronic acid | Active comparator | Device: Hyaluronic Acid (HA)Single intra-articular knee injection of 4.8 mL hyaluronic acid gel containing sodium hyaluronate (25 mg/mL; total dose: 120 mg). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Knee osteoarthritis meeting American College of Rheumatology (ACR) criteria
- Kellgren-Lawrence radiographic grade II or III
- Pain intensity in the study knee NRS >= 4 and in the contralateral knee NRS <= 2
- Written informed consent
Key exclusion criteria (8 listed)
- BMI >= 40 kg/m2
- Surgery of the same or contralateral knee within the previous year
- Intra-articular corticosteroid injection into the study joint within 3 months, or hyaluronic acid, platelet-rich plasma or other intra-articular injection therapy within 6 months before enrolment
- Systemic corticosteroid use within 2 weeks
- Systemic inflammatory or autoimmune disease with joint involvement (rheumatoid arthritis, spondyloarthropathy, systemic lupus erythematosus, etc.)
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 |
|---|---|---|
| Hyaluronic Acid (HA) and Platelet rich plasma (PRP)Procedure kit enabling preparation of autologous platelet-rich plasma (PRP) from the participant's venous blood and intra-articular administration combined with sodium hyaluronate. The procedure includes preparation of PRP using a separation device and injection of a total volume of 4.8 mL consisting of 3.8 mL of 2.5% sodium hyaluronate and 1 mL of autologous PRP. | Device | Hyaluronic acid with autologous plateletrich plasma |
| Hyaluronic Acid (HA)Pre-filled syringe containing 4.8 mL of sterile, nonpyrogenic hyaluronic acid gel for intra-articular injection. The product contains sodium hyaluronate at a concentration of 25 mg/mL (total dose: 120 mg), produced by bacterial fermentation and of non-animal origin. | Device | Hyaluronic acid |
Primary outcome
Change in knee pain intensity on the Numeric Rating Scale (NRS)
Time frame: Baseline to 6 months
The Numeric Rating Scale (NRS) for pain is an 11-point single-item scale on which the participant rates knee pain intensity over the past week from 0 (no pain) to 10 (worst imaginable pain). The outcome is the between-group difference in change from baseline; a greater decrease indicates greater improvement.
6 secondary outcomes
Change in knee pain intensity as measured by the Numeric Rating Scale (NRS) at additional time points
Time frame: Baseline, 1, 3, 12 and 18 months
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores
Time frame: Baseline, 1, 3, 6, 12 and 18 months
Change in Knee Injury and Osteoarthritis Outcome Score (KOOS) subscale scores
Time frame: Baseline to 18 months
Number of participants with at least one treatment-emergent adverse event (AE)
Time frame: Baseline to 18 months
Number of treatment-emergent adverse events (AEs)
Time frame: Baseline to 18 months]
Number of participants discontinuing the study due to an adverse event (AE)
Time frame: Baseline to 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Jaromir Jarecki, DSc principal investigator
Przychodnia Specjalistyczna Lancet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic Acid (HA) and Platelet rich plasma (PRP) and Hyaluronic Acid (HA) in people with Knee Osteoarthritis and Knee Osteoarthritis (Knee OA), run by Implai Sp z o.o at 1 site in Poland.
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 4 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 25 Aug 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eliza Fiedorczuk (+48 58 660 44 88, clinical@implai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in knee pain intensity on the Numeric Rating Scale (NRS) (time frame: Baseline to 6 months). 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 25 Aug 2026.