Knee Osteoarthritis (Kellgren-Lawrence Grade 1-3)NCT07857954
Comparison of Leucocyte-rich PRP and Leucocyte-poor PRP in Treating Mild to Moderate Knee Osteoarthritis
A study testing Intra-articular platelet-rich plasma in people with Knee Osteoarthritis (Kellgren-Lawrence Grade 1-3) and Knee Osteoarthritis, run by St. Catherine Specialty Hospital at 1 site in Croatia.
Trial summary
The purpose of this study is to show that there is no difference in patient clinical scores when patients with knee pain are treated with joint application of high dose white blood cell PRP (platelet-rich plasma) and low dose white blood cell PRP for knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Knee Osteoarthritis (Kellgren-Lawrence Grade 1-3), Knee Osteoarthritis, PRP
- What is being tested?
- Intra-articular platelet-rich plasma
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteCroatia
- Study dates
- 28 Nov 2023to 1 Oct 2025
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- patients with knee osteoarthritis aged 18 to 75 years
- Kellgren-Lawrence osteoarthritis grade 1-3
- onset of knee symptoms (pain) at least 6 months prior
- ability to follow study instructions and attend follow-up visits
- signed informed consent for participation in the study
Who cannot join
- patients with malignancies, systemic inflammatory diseases (e.g., rheumatoid arthritis, psoriatic arthritis), or other systemic diseases that may result in knee pain
- patients with a body mass index (BMI) greater than 30 or diabetes
- patients with 6 or more painful body points, distributed above and below the waist, on both sides of the body, and in the axillary region
- patients with depression (according to the CESD-R questionnaire)
- patients with Grade 4 knee osteoarthritis according to the Kellgren-Lawrence classification
- patients with post-traumatic osteoarthritis
Show all 20Show fewer
- patients with rheumatoid arthritis
- patients with a history of knee surgery
- patients with a mechanical axis deviation (valgus/varus) of the lower extremities greater than 5°
- patients with knee instability
- patients with damage to the meniscus or other knee structures as the primary cause of pain and other symptoms
- patients with a history of knee injury within the last 3 months
- patients with other musculoskeletal problems/diseases that would prevent clinical evaluation of the effects of PRP treatment
- patients treated with intra-articular knee injections (corticosteroids, hyaluronic acid, platelet-rich plasma, etc.) within the last 3 months
- patients with joint chondromatosis or villonodular synovitis knee
- knee joint infection
- pregnant patients or patients planning pregnancy during the study period
- history of chemotherapy or radiotherapy to the limb
- patients with mental illness (where cooperation during the project cannot be expected)
- patients determined unable to attend follow-up appointments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Comparison of a Standardized Leukocyte-Poor Platelet-Rich Plasma Preparation and a Standardized Leukocyte-Rich Platelet-Rich Plasma Preparation in the Treatment of Knee Osteoarthritis
The purpose of this study is to show that there is no difference in patient clinical scores when patients with knee pain are treated with joint application of high dose white blood cell PRP (platelet-rich plasma) and low dose white blood cell PRP for knee osteoarthritis. Participants will be selected based on presenting knee pain lasting for 6 months or longer. Before being recruited, they will undergo radiological examinations (X-ray and MRI), based on which they will be recruited. Before application and subjection to randomization, all patients will fill out clinical questionnaires (KOOS,WOMAC,VAS). Afterwards, the participants will be divided randomly into two groups, one receiving high dose white blood cell PRP and the other group receiving low dose white blood cell PRP. Participants will not be aware of which group they are divided into. They will have blood drawn, the blood will be processed into a PRP blood product. The blood product will then be applied into the joint space with the help of ultrasound. The patients will again fill out clinical scores (KOOS,WOMAC,VAS) at the follow-up intervals (1,3,6,12 months). At the end of the study, participants will be allowed to discover which PRP product they received.
- Conditions
- Knee Osteoarthritis (Kellgren-Lawrence Grade 1-3), Knee Osteoarthritis, PRP, Platelet-rich Plasma (PRP)
- Being tested
- Intra-articular platelet-rich plasma
- Keywords
- Platelet-rich-plasma, knee osteoarthritis, Leukocyte-rich PRP, Leukocyte-poor PRP, PRP
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular platelet-rich plasmaBiological
Single injection, ultrasound guided intra-articular knee injection of leukocyte-rich PRP and leukocyte-poor PRP.
| Study group | Role | What they receive |
|---|---|---|
| Leukocyte-Rich PRP | Experimental | Patients in this arm will receive a leukocyte-rich PRP preparation. Receives: Biological: Intra-articular platelet-rich plasma |
| Leukocyte-Poor PRP | Experimental | Patients in this arm will receive a leukocyte-poor PRP preparation. Receives: Biological: Intra-articular platelet-rich plasma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee injury and Osteoarthritis Outcome Score
Scored from 0 to 100 where 0 means extreme knee problems and 100 means no knee problems.
Measured: 0 month, 1 month, 3 months, 6 months and 12 months
Visual analogue scale
Scored from 0 to 10 where 0 means no pain and 10 means the worst pain.
Measured: 0 month, 1 month, 3 months, 6 months and 12 months
The Western Ontario and McMaster Universities Osteoarthritis Index
Scored from 0 to 100 where 0 means no symptoms and 100 means major loss of independence.
Measured: 0 month, 1 month, 3 months, 6 months and 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start28 Nov 2023
- Primary completion18 Jul 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Knee Osteoarthritis (Kellgren-Lawrence Grade 1-3)Studies 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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Catherine Specialty Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eduard Stjepan Pavelic, St. Catherine Specialty Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07857954
- Sponsor's protocol ID
- StCatharineCroatia
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Any IPD that does not breach European GDPR guidelines upon request by ICMJE
Publications
Dell'Isola A, Allan R, Smith SL, Marreiros SS, Steultjens M. Identification of clinical phenotypes in knee osteoarthritis: a systematic review of the literature. BMC Musculoskelet Disord. 2016 Oct 12;17(1):425. doi: 10.1186/s12891-016-1286-2.
PubMed 27733199Le ADK, Enweze L, DeBaun MR, Dragoo JL. Current Clinical Recommendations for Use of Platelet-Rich Plasma. Curr Rev Musculoskelet Med. 2018 Dec;11(4):624-634. doi: 10.1007/s12178-018-9527-7.
PubMed 30353479Di Martino A, Boffa A, Andriolo L, Romandini I, Altamura SA, Cenacchi A, Roverini V, Zaffagnini S, Filardo G. Leukocyte-Rich versus Leukocyte-Poor Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis: A Double-Blind Randomized Trial. Am J Sports Med. 2022 Mar;50(3):609-617. doi: 10.1177/03635465211064303. Epub 2022 Feb 1.
PubMed 35103547Hong Z, Chen J, Zhang S, Zhao C, Bi M, Chen X, Bi Q. Intra-articular injection of autologous adipose-derived stromal vascular fractions for knee osteoarthritis: a double-blind randomized self-controlled trial. Int Orthop. 2019 May;43(5):1123-1134. doi: 10.1007/s00264-018-4099-0. Epub 2018 Aug 14.
PubMed 30109404Belk JW, Kraeutler MJ, Houck DA, Goodrich JA, Dragoo JL, McCarty EC. Platelet-Rich Plasma Versus Hyaluronic Acid for Knee Osteoarthritis: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Am J Sports Med. 2021 Jan;49(1):249-260. doi: 10.1177/0363546520909397. Epub 2020 Apr 17.
PubMed 32302218Sundman EA, Cole BJ, Fortier LA. Growth factor and catabolic cytokine concentrations are influenced by the cellular composition of platelet-rich plasma. Am J Sports Med. 2011 Oct;39(10):2135-40. doi: 10.1177/0363546511417792. Epub 2011 Aug 16.
PubMed 21846925Taichman NS, Young S, Cruchley AT, Taylor P, Paleolog E. Human neutrophils secrete vascular endothelial growth factor. J Leukoc Biol. 1997 Sep;62(3):397-400. doi: 10.1002/jlb.62.3.397.
PubMed 9307080Martin KE, Garcia AJ. Macrophage phenotypes in tissue repair and the foreign body response: Implications for biomaterial-based regenerative medicine strategies. Acta Biomater. 2021 Oct 1;133:4-16. doi: 10.1016/j.actbio.2021.03.038. Epub 2021 Mar 26.
PubMed 33775905Atri C, Guerfali FZ, Laouini D. Role of Human Macrophage Polarization in Inflammation during Infectious Diseases. Int J Mol Sci. 2018 Jun 19;19(6):1801. doi: 10.3390/ijms19061801.
PubMed 29921749Fedorova NV, Ksenofontov AL, Serebryakova MV, Stadnichuk VI, Gaponova TV, Baratova LA, Sud'ina GF, Galkina SI. Neutrophils Release Metalloproteinases during Adhesion in the Presence of Insulin, but Cathepsin G in the Presence of Glucagon. Mediators Inflamm. 2018 Feb 14;2018:1574928. doi: 10.1155/2018/1574928. eCollection 2018.
PubMed 29670459Weirather J, Hofmann UD, Beyersdorf N, Ramos GC, Vogel B, Frey A, Ertl G, Kerkau T, Frantz S. Foxp3+ CD4+ T cells improve healing after myocardial infarction by modulating monocyte/macrophage differentiation. Circ Res. 2014 Jun 20;115(1):55-67. doi: 10.1161/CIRCRESAHA.115.303895. Epub 2014 Apr 30.
PubMed 24786398Knezevic NN, Candido KD, Desai R, Kaye AD. Is Platelet-Rich Plasma a Future Therapy in Pain Management? Med Clin North Am. 2016 Jan;100(1):199-217. doi: 10.1016/j.mcna.2015.08.014.
PubMed 26614728Everts P, Onishi K, Jayaram P, Lana JF, Mautner K. Platelet-Rich Plasma: New Performance Understandings and Therapeutic Considerations in 2020. Int J Mol Sci. 2020 Oct 21;21(20):7794. doi: 10.3390/ijms21207794.
PubMed 33096812Dubin J, Leucht P, Murray M, Pezold R; Staff of the American Academy of Orthopaedic Surgeons on Behalf of the Platelet-Rich Plasma (PRP) for Knee Osteoarthritis Technology Overview Workgroup and Contributors. American Academy of Orthopaedic Surgeons Technology Overview Summary: Platelet-Rich Plasma (PRP) for Knee Osteoarthritis. J Am Acad Orthop Surg. 2024 Apr 1;32(7):296-301. doi: 10.5435/JAAOS-D-23-00957. Epub 2024 Jan 30.
PubMed 38295392Moojen DJ, Everts PA, Schure RM, Overdevest EP, van Zundert A, Knape JT, Castelein RM, Creemers LB, Dhert WJ. Antimicrobial activity of platelet-leukocyte gel against Staphylococcus aureus. J Orthop Res. 2008 Mar;26(3):404-10. doi: 10.1002/jor.20519.
PubMed 17960651
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Comparison of a Standardized Leukocyte-Poor Platelet-Rich Plasma Preparation and a Standardized Leukocyte-Rich Platelet-Rich Plasma Preparation in the Treatment of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT07857954
- Acronym / sponsor ID
- StCatharineCroatia
- Conditions
- Knee Osteoarthritis (Kellgren-Lawrence Grade 1-3), Knee Osteoarthritis, PRP, Platelet-rich Plasma (PRP)
- Keywords
- Platelet-rich-plasma, knee osteoarthritis, Leukocyte-rich PRP, Leukocyte-poor PRP, PRP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- St. Catherine Specialty HospitalUniversity, hospital or other
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 18 Jul 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 5 Oct 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.
The purpose of this study is to show that there is no difference in patient clinical scores when patients with knee pain are treated with joint application of high dose white blood cell PRP (platelet-rich plasma) and low dose white blood cell PRP for knee osteoarthritis. Participants will be selected based on presenting knee pain lasting for 6 months or longer. Before being recruited, they will undergo radiological examinations (X-ray and MRI), based on which they will be recruited. Before application and subjection to randomization, all patients will fill out clinical questionnaires (KOOS,WOMAC,VAS). Afterwards, the participants will be divided randomly into two groups, one receiving high dose white blood cell PRP and the other group receiving low dose white blood cell PRP. Participants will not be aware of which group they are divided into. They will have blood drawn, the blood will be processed into a PRP blood product. The blood product will then be applied into the joint space with the help of ultrasound. The patients will again fill out clinical scores (KOOS,WOMAC,VAS) at the follow-up intervals (1,3,6,12 months). At the end of the study, participants will be allowed to discover which PRP product they received.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Leukocyte-Rich PRP | Experimental | Biological: Intra-articular platelet-rich plasmaPatients in this arm will receive a leukocyte-rich PRP preparation. |
| Leukocyte-Poor PRP | Experimental | Biological: Intra-articular platelet-rich plasmaPatients in this arm will receive a leukocyte-poor PRP preparation. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients with knee osteoarthritis aged 18 to 75 years
- Kellgren-Lawrence osteoarthritis grade 1-3
- onset of knee symptoms (pain) at least 6 months prior
- ability to follow study instructions and attend follow-up visits
- signed informed consent for participation in the study
Key exclusion criteria (20 listed)
- patients with malignancies, systemic inflammatory diseases (e.g., rheumatoid arthritis, psoriatic arthritis), or other systemic diseases that may result in knee pain
- patients with a body mass index (BMI) greater than 30 or diabetes
- patients with 6 or more painful body points, distributed above and below the waist, on both sides of the body, and in the axillary region
- patients with depression (according to the CESD-R questionnaire)
- patients with Grade 4 knee osteoarthritis according to the Kellgren-Lawrence classification
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 |
|---|---|---|
| Intra-articular platelet-rich plasmaSingle injection, ultrasound guided intra-articular knee injection of leukocyte-rich PRP and leukocyte-poor PRP. | Biological | Leukocyte-Poor PRP, Leukocyte-Rich PRP |
Primary outcome
Knee injury and Osteoarthritis Outcome Score
Time frame: 0 month, 1 month, 3 months, 6 months and 12 months
Scored from 0 to 100 where 0 means extreme knee problems and 100 means no knee problems.
Visual analogue scale
Time frame: 0 month, 1 month, 3 months, 6 months and 12 months
Scored from 0 to 10 where 0 means no pain and 10 means the worst pain.
The Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: 0 month, 1 month, 3 months, 6 months and 12 months.
Scored from 0 to 100 where 0 means no symptoms and 100 means major loss of independence.
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 7 Oct 2026.
- Background: PubMed 27733199Dell'Isola A, Allan R, Smith SL, Marreiros SS, Steultjens M. Identification of clinical phenotypes in knee osteoarthritis: a systematic review of the literature. BMC Musculoskelet Disord. 2016 Oct 12;17(1):425. doi: 10.1186/s12891-016-1286-2.
- Background: PubMed 30353479Le ADK, Enweze L, DeBaun MR, Dragoo JL. Current Clinical Recommendations for Use of Platelet-Rich Plasma. Curr Rev Musculoskelet Med. 2018 Dec;11(4):624-634. doi: 10.1007/s12178-018-9527-7.
- Background: PubMed 35103547Di Martino A, Boffa A, Andriolo L, Romandini I, Altamura SA, Cenacchi A, Roverini V, Zaffagnini S, Filardo G. Leukocyte-Rich versus Leukocyte-Poor Platelet-Rich Plasma for the Treatment of Knee Osteoarthritis: A Double-Blind Randomized Trial. Am J Sports Med. 2022 Mar;50(3):609-617. doi: 10.1177/03635465211064303. Epub 2022 Feb 1.
- Background: PubMed 30109404Hong Z, Chen J, Zhang S, Zhao C, Bi M, Chen X, Bi Q. Intra-articular injection of autologous adipose-derived stromal vascular fractions for knee osteoarthritis: a double-blind randomized self-controlled trial. Int Orthop. 2019 May;43(5):1123-1134. doi: 10.1007/s00264-018-4099-0. Epub 2018 Aug 14.
- Background: PubMed 32302218Belk JW, Kraeutler MJ, Houck DA, Goodrich JA, Dragoo JL, McCarty EC. Platelet-Rich Plasma Versus Hyaluronic Acid for Knee Osteoarthritis: A Systematic Review and Meta-analysis of Randomized Controlled Trials. Am J Sports Med. 2021 Jan;49(1):249-260. doi: 10.1177/0363546520909397. Epub 2020 Apr 17.
- Background: PubMed 21846925Sundman EA, Cole BJ, Fortier LA. Growth factor and catabolic cytokine concentrations are influenced by the cellular composition of platelet-rich plasma. Am J Sports Med. 2011 Oct;39(10):2135-40. doi: 10.1177/0363546511417792. Epub 2011 Aug 16.
- Background: PubMed 9307080Taichman NS, Young S, Cruchley AT, Taylor P, Paleolog E. Human neutrophils secrete vascular endothelial growth factor. J Leukoc Biol. 1997 Sep;62(3):397-400. doi: 10.1002/jlb.62.3.397.
- Background: PubMed 33775905Martin KE, Garcia AJ. Macrophage phenotypes in tissue repair and the foreign body response: Implications for biomaterial-based regenerative medicine strategies. Acta Biomater. 2021 Oct 1;133:4-16. doi: 10.1016/j.actbio.2021.03.038. Epub 2021 Mar 26.
- Background: PubMed 29921749Atri C, Guerfali FZ, Laouini D. Role of Human Macrophage Polarization in Inflammation during Infectious Diseases. Int J Mol Sci. 2018 Jun 19;19(6):1801. doi: 10.3390/ijms19061801.
- Background: PubMed 29670459Fedorova NV, Ksenofontov AL, Serebryakova MV, Stadnichuk VI, Gaponova TV, Baratova LA, Sud'ina GF, Galkina SI. Neutrophils Release Metalloproteinases during Adhesion in the Presence of Insulin, but Cathepsin G in the Presence of Glucagon. Mediators Inflamm. 2018 Feb 14;2018:1574928. doi: 10.1155/2018/1574928. eCollection 2018.
- Background: PubMed 24786398Weirather J, Hofmann UD, Beyersdorf N, Ramos GC, Vogel B, Frey A, Ertl G, Kerkau T, Frantz S. Foxp3+ CD4+ T cells improve healing after myocardial infarction by modulating monocyte/macrophage differentiation. Circ Res. 2014 Jun 20;115(1):55-67. doi: 10.1161/CIRCRESAHA.115.303895. Epub 2014 Apr 30.
- Background: PubMed 26614728Knezevic NN, Candido KD, Desai R, Kaye AD. Is Platelet-Rich Plasma a Future Therapy in Pain Management? Med Clin North Am. 2016 Jan;100(1):199-217. doi: 10.1016/j.mcna.2015.08.014.
- Individual participant dataSharing planned: Yes. Any IPD that does not breach European GDPR guidelines upon request by ICMJE
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intra-articular platelet-rich plasma in people with Knee Osteoarthritis (Kellgren-Lawrence Grade 1-3) and Knee Osteoarthritis, run by St. Catherine Specialty Hospital at 1 site in Croatia.
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 5 inclusion and 20 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 7 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 Croatia. 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?
Knee injury and Osteoarthritis Outcome Score (time frame: 0 month, 1 month, 3 months, 6 months and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07857954, which also lists 21 linked publications.
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 7 Oct 2026.