Osteo Arthritis KneeNCT06685120
Combined Use of PRP and Hyaluronic Acid for Infiltrative Treatment of Patients With Knee Osteoarthritis
A study testing PRP + HA injection, PRP injection and HA injection in people with Osteo Arthritis Knee, run by Istituto Ortopedico Rizzoli at 2 sites in Italy.
Trial summary
"PRP+HA-23" is a double-blind randomized controlled clinical trial with 1:1:1 allocation. The objective of the study is to evaluate by a randomized controlled, double-blind clinical trial the efficacy and safety of viscosupplementation-associated PRP infiltration compared with PRP-only or HA-only infiltration for the… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- PRP + HA injection, PRP injection and HA injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 2 sitesItaly
- Study dates
- 11 Dec 2025to Sep 2029
- 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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female patients, aged 40 to 75 years;
- Patients with symptomatic knee osteoarthritis (VAS pain score between ≥ 3 and ≤ 8);
- Unilateral involvement of symptomatology;
- Radiographic or MRI signs of degenerative pathology of knee cartilage (Kellgren-Lawrence grade 1-3);
- Failure, defined as the persistence of symptomatology, after at least one course of conservative treatment (pharmacological, physiotherapeutic or infiltrative treatment);
- Hemoglobin > 11 g/dl; Platelet count > 150,000 plt/mm3 (Recently performed CBC examination);
- Ability and consent of patients to actively participate in clinical follow-up;
- Signature of informed consent.
Who cannot join
- Patients unable to express consent;
- Patients undergoing intra-articular infiltration of other substance in the previous 6 months;
- Patients undergoing knee surgery in the previous 12 months;
- Patients with malignant neoplasms;
- Patients with rheumatic diseases;
- Patients with uncontrolled diabetes;
Show all 15Show fewer
- Patients with hematological diseases (coagulopathies);
- Patients on anticoagulant-antiaggregant therapy that cannot be discontinued at the time of blood collection;
- Patients with uncompensated thyroid metabolic disorders;
- Patients abusing alcoholic beverages, drugs or medications;
- Body Mass Index > 35;
- Patients who have taken NSAIDs in the 3 days prior to blood draw;
- Patients with cardiovascular disease for whom blood sampling 30 to 60 ml would be contraindicated;
- Patients with recently performed CBC examination with Hb< 11 g/dl and Platelet values < 150,000 plt/mm3.
- Pregnant and/or fertile women.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Not yet recruiting
IRCCS Istituto Ortopedico Rizzoli
Bologna, 40136
Davide Reale, MD, 0516366567, davide.reale@ior.it
Roberta Licciardi, MSc, 0516366567, roberta.licciardi@ior.it
- Recruiting
Istituto Ortopedico Rizzoli
Bologna, 40136
Davide Reale, MD, davide.reale@ior.it
Roberta Licciardi, MSc, roberta.licciardi@ior.it
About this study
Official title: Combined Use of PRP and Hyaluronic Acid for Infiltrative Treatment of Patients With Knee Osteoarthritis - Randomized Controlled Clinical Study
"PRP+HA-23" is a double-blind randomized controlled clinical trial with 1:1:1 allocation. The objective of the study is to evaluate by a randomized controlled, double-blind clinical trial the efficacy and safety of viscosupplementation-associated PRP infiltration compared with PRP-only or HA-only infiltration for the treatment of patients with knee osteoarthritis.
Read the detailed description
Patients with osteoarthritis of the knee will be included in a randomized controlled, double-blind study, in which one group of patients will be treated with an infiltration of PRP combined with HA (PRP + HA group), one group of patients will be treated with an infiltration of PRP alone (PRP group), and another group of patients will be treated with an infiltration of HA alone (HA group). They will be "blinded" patients, health care professionals who will assess clinical and functional outcomes (outcome assessors), and professionals who will analyze the data.
A total of 288 patients will be included, and they will undergo infiltrative treatment after collecting informed consent for study participation and biographical data.
All enrolled patients undergo transfusion evaluation and venous whole blood sampling from 30 to 60 mL depending on the patient's hematocrit. From the withdrawn blood, which will be collected in tubes of 9 mL each, fresh autologous PRP (PRP) will subsequently be obtained. To maintain study blinding, all patients will have their blood drawn but PRP will not be produced for patients randomized into the HA group.Following autologous PRP harvesting and production, patients randomized into the treatment group will undergo single intra-articular infiltration of PRP + HA; patients randomized into the control group 1, will undergo single intra-articular infiltration of PRP; and patients randomized into the control group 2, will undergo similar blood sampling as the PRP+ HA group and the PRP group to maintain blindness. They will then undergo an intra-articular infiltration of HA .Patients will be clinically evaluated before the infiltration procedure and at 1-3-6- 12 and 24 months after treatment by medical personnel. Questionnaires will be administered for clinical evaluations before treatment and at the above-mentioned clinical checks during follow-up
- Conditions
- Osteo Arthritis Knee
- Being tested
- PRP + HA injection, PRP injection, HA injection
- Keywords
- PRP, Platelet rich plasma, HA, Hyaluronic acid, PRP injection, PRP + HA injection, HA injection, Double-blind randomized controlled clinical trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP + HA injectionCombination product
Following autologous PRP harvesting and production, 5 mL of PRP and 40 mg/2 mL of HA will be infiltrated into the knee joint affected by gonarthrosis. The combined procedure will be performed by first infiltrating the hyaluronic acid, and next, leaving the needle inserted into the joint to avoid a second needle insertion, the PRP will be infiltrated, respecting the conditions of sterility. In this way, the two products will not be mixed in the same syringe.
PRP injectionBiological
Following autologous PRP harvesting and production, patients randomized into control group 1 will undergo single intra-articular PRP infiltration. Five mL of PRP will be infiltrated into the knee joint affected by gonarthrosis.
HA injectionDevice
Patients randomized into control group 2, will undergo similar blood sampling as the PRP+ HA group and the PRP group to maintain blinding. They will then undergo intra-articular infiltration of 40 mg/ 2 ml HA into the knee with gonarthrosis.
| Study group | Role | What they receive |
|---|---|---|
| PRP+HA injection | Experimental | This group of patients randomized into the treatment group, will undergo single intra-articular injection of autologous PRP+HA Receives: Combination Product: PRP + HA injection |
| PRP injection | Active comparator | This group of patients randomized into the treatment group, will undergo single intra-articular injection of autologous PRP Receives: Biological: PRP injection |
| HA injection | Active comparator | This group of patients randomized into the treatment group, will undergo single intra-articular injection of HA Receives: Device: HA injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
It's a standardized and widely used questionnaire to assess the condition of patients with osteoarthritis of the knee and includes assessment of pain, stiffness, and physical function of the joints. It can be administered to the patient.
It measures 5 items for pain (range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68) that mainly relate to activities of daily living (e.g., getting up from a sitting position, bending over, going up and down stairs etc.); The score is then normalized on a 0-100 scale. Higher values indicate a worse outcome
Measured: 12 months
Secondary outcomes (14)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
It's a standardized and widely used questionnaire to assess the condition of patients with osteoarthritis of the knee and includes assessment of pain, stiffness, and physical function of the joints. It can be administered to the patient.
It measures 5 items for pain (range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68) that mainly relate to activities of daily living (e.g., getting up from a sitting position, bending over, going up and down stairs etc.); The score is then normalized on a 0-100 scale. Higher values indicate a worse outcome
Measured: baseline, 1,3,6 and 24 months
IKDC-Subjective Score (Subjective International Knee Documentation Committee)
This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathology. The questionnaire examines 3 categories: symptoms, sports activity, and knee function.
(Total score 0-100)
Measured: baseline, 1,3,6, 12 and 24 months
Objective parameters- Range of Motion
Evaluation of the Range of Motion for comparative analysis.
Measured: baseline, 1,3,6, 12 and 24 months
Objective parameters - Circumferences
Bilateral trans- and supra- patellar circumferences measurement for comparative analysis
Measured: baseline, 1,3,6, 12 and 24 months
Knee Injury and Osteoarthritis Outcome Score (KOOS)
This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathology. The questionnaire examines the following categories: symptoms, stiffness, pain, daily activities, sports and quality of life.
Each question is scored from 0 to 4, where 0 indicates "no difficulty" and 4 "severe difficulty. Score range 0-100 for each subscale
Measured: baseline, 1,3,6, 12 and 24 months
Visual Analogue Scale (VAS) (rest)
Visual analog scale consisting of a straight line segment (10 cm length), the ends of which correspond to "no pain" (0) and "the strongest pain imaginable" (10) during rest
Measured: baseline, 1,3,6, 12 and 24 months
Visual Analogue Scale (VAS) (exercise activity)
Visual analog scale consisting of a straight line segment (10 cm length), the ends of which correspond to "no pain" (0) and "the strongest pain imaginable" (10) during exercise activity
Measured: baseline, 1,3,6, 12 and 24 months
EuroQol Visual Analogue Scale (EQ-VAS)
EQ-VAS is a visual analog scale that has a range of scores from 0 (worst imaginable health condition) to 100 (best imaginable health condition).
Measured: baseline, 1,3,6, 12 and 24 months
EQ-5D (EuroQoL) Current Health Assessment
The generic health-related quality of life instrument-EQ-5D-allows both a description of health status along 5 dimensions and the evaluation of health or the estimation of a health summary score: the EQ-5D score on a scale where 0 is death and 1 is full health. EQ-5D is useful to evaluate the quality life of the patients. The EQ-5D respondents classify their own health status into 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression with 3 levels of severity (no problems, moderate problems, or severe problems).
Measured: baseline, 1,3,6, 12 and 24 months
Tegner Activity Level Scale
Tegner Activity Level Scale is a questionnaire to find out the patient's level of physical activity.All patients will indicate the type of sporting activity performed and its frequency.
The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability and 10 represents a competitive level of sport.
Measured: baseline, 1,3,6, 12 and 24 months
Patient Acceptable Symptom State (PASS)
A tool to assess patient satisfaction in consideration of their current degree of pain, function, and daily activity. Patients can express if their state of health will be satisfying, answering "yes" or "no.
Measured: baseline, 1,3,6, 12 and 24 months
Final treatment opinion
The patient should indicate satisfaction and relative degree with treatment at the end of the clinical trial. All patients will be able to indicate their health condition by choosing from this answers; "Full recovery", "", "much better", "somewhat better", "no change", "a little worse" ; "much worse"
Measured: 1,3,6, 12 and 24 months
Effectiveness of the blinding procedure
The patient should indicate, after the infiltrative procedure, the type of treatment they think they received.The patient should choose from the following options:
"PRP+HA infiltration," PRP infiltration", "HA infiltration". This question is designed to test the effectiveness of the blinding procedure
Measured: baseline
Expectations of treatment efficacy
The patient should indicate at baseline what benefits they expect from the treatment.
The patient should choose one of the following options:
"Full recovery," "definitely better","much better", "somewhat better", "no change"
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start11 Dec 2025
- Primary completionSep 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- More trials run by Istituto Ortopedico RizzoliThe 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
- Model description
- This is a double-blind randomized controlled clinical trial with 1:1:1 allocation
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 288 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Ferrara
- Responsible party
- Sponsor
- Investigators
- Davide Reale, MD, Principal investigator, Istituto Ortopedico Rizzoli - Argenta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685120
- Sponsor's protocol ID
- PRP+HA-23
- Status last verified
- Jan 2026
- First submitted
- 11 Nov 2024
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Boffa A, Salerno M, Merli G, De Girolamo L, Laver L, Magalon J, Sanchez M, Tischer T, Filardo G. Platelet-rich plasma injections induce disease-modifying effects in the treatment of osteoarthritis in animal models. Knee Surg Sports Traumatol Arthrosc. 2021 Dec;29(12):4100-4121. doi: 10.1007/s00167-021-06659-9. Epub 2021 Aug 2.
PubMed 34341845Filardo G, Previtali D, Napoli F, Candrian C, Zaffagnini S, Grassi A. PRP Injections for the Treatment of Knee Osteoarthritis: A Meta-Analysis of Randomized Controlled Trials. Cartilage. 2021 Dec;13(1_suppl):364S-375S. doi: 10.1177/1947603520931170. Epub 2020 Jun 19.
PubMed 32551947Chen WH, Lo WC, Hsu WC, Wei HJ, Liu HY, Lee CH, Tina Chen SY, Shieh YH, Williams DF, Deng WP. Synergistic anabolic actions of hyaluronic acid and platelet-rich plasma on cartilage regeneration in osteoarthritis therapy. Biomaterials. 2014 Dec;35(36):9599-607. doi: 10.1016/j.biomaterials.2014.07.058. Epub 2014 Aug 28.
PubMed 25176059Chiou CS, Wu CM, Dubey NK, Lo WC, Tsai FC, Tung TDX, Hung WC, Hsu WC, Chen WH, Deng WP. Mechanistic insight into hyaluronic acid and platelet-rich plasma-mediated anti-inflammatory and anti-apoptotic activities in osteoarthritic mice. Aging (Albany NY). 2018 Dec 23;10(12):4152-4165. doi: 10.18632/aging.101713.
PubMed 30582743Zhang Q, Liu T, Gu Y, Gao Y, Ni J. Efficacy and safety of platelet-rich plasma combined with hyaluronic acid versus platelet-rich plasma alone for knee osteoarthritis: a systematic review and meta-analysis. J Orthop Surg Res. 2022 Nov 19;17(1):499. doi: 10.1186/s13018-022-03398-6.
PubMed 36403041Lana JF, Weglein A, Sampson SE, Vicente EF, Huber SC, Souza CV, Ambach MA, Vincent H, Urban-Paffaro A, Onodera CM, Annichino-Bizzacchi JM, Santana MH, Belangero WD. Randomized controlled trial comparing hyaluronic acid, platelet-rich plasma and the combination of both in the treatment of mild and moderate osteoarthritis of the knee. J Stem Cells Regen Med. 2016 Nov 29;12(2):69-78. doi: 10.46582/jsrm.1202011. eCollection 2016.
PubMed 28096631
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Use of PRP and Hyaluronic Acid for Infiltrative Treatment of Patients With Knee Osteoarthritis - Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06685120
- Acronym / sponsor ID
- PRP+HA-23
- Conditions
- Osteo Arthritis Knee
- Keywords
- PRP, Platelet rich plasma, HA, Hyaluronic acid, PRP injection, PRP + HA injection, HA injection, Double-blind randomized controlled clinical trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 288 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Collaborators
- University Hospital of Ferrara
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- Sep 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 12 Nov 2024 (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.
"PRP+HA-23" is a double-blind randomized controlled clinical trial with 1:1:1 allocation. The objective of the study is to evaluate by a randomized controlled, double-blind clinical trial the efficacy and safety of viscosupplementation-associated PRP infiltration compared with PRP-only or HA-only infiltration for the treatment of patients with knee osteoarthritis.
Detailed description
Patients with osteoarthritis of the knee will be included in a randomized controlled, double-blind study, in which one group of patients will be treated with an infiltration of PRP combined with HA (PRP + HA group), one group of patients will be treated with an infiltration of PRP alone (PRP group), and another group of patients will be treated with an infiltration of HA alone (HA group). They will be "blinded" patients, health care professionals who will assess clinical and functional outcomes (outcome assessors), and professionals who will analyze the data.
A total of 288 patients will be included, and they will undergo infiltrative treatment after collecting informed consent for study participation and biographical data.
All enrolled patients undergo transfusion evaluation and venous whole blood sampling from 30 to 60 mL depending on the patient's hematocrit. From the withdrawn blood, which will be collected in tubes of 9 mL each, fresh autologous PRP (PRP) will subsequently be obtained. To maintain study blinding, all patients will have their blood drawn but PRP will not be produced for patients randomized into the HA group.Following autologous PRP harvesting and production, patients randomized into the treatment group will undergo single intra-articular infiltration of PRP + HA; patients randomized into the control group 1, will undergo single intra-articular infiltration of PRP; and patients randomized into the control group 2, will undergo similar blood sampling as the PRP+ HA group and the PRP group to maintain blindness. They will then undergo an intra-articular infiltration of HA .Patients will be clinically evaluated before the infiltration procedure and at 1-3-6- 12 and 24 months after treatment by medical personnel. Questionnaires will be administered for clinical evaluations before treatment and at the above-mentioned clinical checks during follow-up
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a double-blind randomized controlled clinical trial with 1:1:1 allocation
| Arm | Type | Receives |
|---|---|---|
| PRP+HA injection | Experimental | Combination Product: PRP + HA injectionThis group of patients randomized into the treatment group, will undergo single intra-articular injection of autologous PRP+HA |
| PRP injection | Active comparator | Biological: PRP injectionThis group of patients randomized into the treatment group, will undergo single intra-articular injection of autologous PRP |
| HA injection | Active comparator | Device: HA injectionThis group of patients randomized into the treatment group, will undergo single intra-articular injection of HA |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female patients, aged 40 to 75 years;
- Patients with symptomatic knee osteoarthritis (VAS pain score between ≥ 3 and ≤ 8);
- Unilateral involvement of symptomatology;
- Radiographic or MRI signs of degenerative pathology of knee cartilage (Kellgren-Lawrence grade 1-3);
- Failure, defined as the persistence of symptomatology, after at least one course of conservative treatment (pharmacological, physiotherapeutic or infiltrative treatment);
Key exclusion criteria (15 listed)
- Patients unable to express consent;
- Patients undergoing intra-articular infiltration of other substance in the previous 6 months;
- Patients undergoing knee surgery in the previous 12 months;
- Patients with malignant neoplasms;
- Patients with rheumatic diseases;
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 |
|---|---|---|
| PRP + HA injectionFollowing autologous PRP harvesting and production, 5 mL of PRP and 40 mg/2 mL of HA will be infiltrated into the knee joint affected by gonarthrosis. The combined procedure will be performed by first infiltrating the hyaluronic acid, and next, leaving the needle inserted into the joint to avoid a second needle insertion, the PRP will be infiltrated, respecting the conditions of sterility. In this way, the two products will not be mixed in the same syringe. | Combination product | PRP+HA injection |
| PRP injectionFollowing autologous PRP harvesting and production, patients randomized into control group 1 will undergo single intra-articular PRP infiltration. Five mL of PRP will be infiltrated into the knee joint affected by gonarthrosis. | Biological | PRP injection |
| HA injectionPatients randomized into control group 2, will undergo similar blood sampling as the PRP+ HA group and the PRP group to maintain blinding. They will then undergo intra-articular infiltration of 40 mg/ 2 ml HA into the knee with gonarthrosis. | Device | HA injection |
Primary outcome
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: 12 months
It's a standardized and widely used questionnaire to assess the condition of patients with osteoarthritis of the knee and includes assessment of pain, stiffness, and physical function of the joints. It can be administered to the patient. It measures 5 items for pain (range 0-20), two for stiffness (range 0-8), and 17 for functional limitation (range 0-68) that mainly relate to activities of daily living (e.g., getting up from a sitting position, bending over, going up and down stairs etc.); The score is then normalized on a 0-100 scale. Higher values indicate a worse outcome
14 secondary outcomes
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: baseline, 1,3,6 and 24 months
IKDC-Subjective Score (Subjective International Knee Documentation Committee)
Time frame: baseline, 1,3,6, 12 and 24 months
Objective parameters- Range of Motion
Time frame: baseline, 1,3,6, 12 and 24 months
Objective parameters - Circumferences
Time frame: baseline, 1,3,6, 12 and 24 months
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: baseline, 1,3,6, 12 and 24 months
Visual Analogue Scale (VAS) (rest)
Time frame: baseline, 1,3,6, 12 and 24 months
Visual Analogue Scale (VAS) (exercise activity)
Time frame: baseline, 1,3,6, 12 and 24 months
EuroQol Visual Analogue Scale (EQ-VAS)
Time frame: baseline, 1,3,6, 12 and 24 months
EQ-5D (EuroQoL) Current Health Assessment
Time frame: baseline, 1,3,6, 12 and 24 months
Tegner Activity Level Scale
Time frame: baseline, 1,3,6, 12 and 24 months
Patient Acceptable Symptom State (PASS)
Time frame: baseline, 1,3,6, 12 and 24 months
Final treatment opinion
Time frame: 1,3,6, 12 and 24 months
Effectiveness of the blinding procedure
Time frame: baseline
Expectations of treatment efficacy
Time frame: baseline
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 3 Feb 2026.
- Background: PubMed 34341845Boffa A, Salerno M, Merli G, De Girolamo L, Laver L, Magalon J, Sanchez M, Tischer T, Filardo G. Platelet-rich plasma injections induce disease-modifying effects in the treatment of osteoarthritis in animal models. Knee Surg Sports Traumatol Arthrosc. 2021 Dec;29(12):4100-4121. doi: 10.1007/s00167-021-06659-9. Epub 2021 Aug 2.
- Background: PubMed 32551947Filardo G, Previtali D, Napoli F, Candrian C, Zaffagnini S, Grassi A. PRP Injections for the Treatment of Knee Osteoarthritis: A Meta-Analysis of Randomized Controlled Trials. Cartilage. 2021 Dec;13(1_suppl):364S-375S. doi: 10.1177/1947603520931170. Epub 2020 Jun 19.
- Background: PubMed 25176059Chen WH, Lo WC, Hsu WC, Wei HJ, Liu HY, Lee CH, Tina Chen SY, Shieh YH, Williams DF, Deng WP. Synergistic anabolic actions of hyaluronic acid and platelet-rich plasma on cartilage regeneration in osteoarthritis therapy. Biomaterials. 2014 Dec;35(36):9599-607. doi: 10.1016/j.biomaterials.2014.07.058. Epub 2014 Aug 28.
- Background: PubMed 30582743Chiou CS, Wu CM, Dubey NK, Lo WC, Tsai FC, Tung TDX, Hung WC, Hsu WC, Chen WH, Deng WP. Mechanistic insight into hyaluronic acid and platelet-rich plasma-mediated anti-inflammatory and anti-apoptotic activities in osteoarthritic mice. Aging (Albany NY). 2018 Dec 23;10(12):4152-4165. doi: 10.18632/aging.101713.
- Background: PubMed 36403041Zhang Q, Liu T, Gu Y, Gao Y, Ni J. Efficacy and safety of platelet-rich plasma combined with hyaluronic acid versus platelet-rich plasma alone for knee osteoarthritis: a systematic review and meta-analysis. J Orthop Surg Res. 2022 Nov 19;17(1):499. doi: 10.1186/s13018-022-03398-6.
- Background: PubMed 28096631Lana JF, Weglein A, Sampson SE, Vicente EF, Huber SC, Souza CV, Ambach MA, Vincent H, Urban-Paffaro A, Onodera CM, Annichino-Bizzacchi JM, Santana MH, Belangero WD. Randomized controlled trial comparing hyaluronic acid, platelet-rich plasma and the combination of both in the treatment of mild and moderate osteoarthritis of the knee. J Stem Cells Regen Med. 2016 Nov 29;12(2):69-78. doi: 10.46582/jsrm.1202011. eCollection 2016.
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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.
Davide Reale, MD principal investigator
Istituto Ortopedico Rizzoli - Argenta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP + HA injection, PRP injection and HA injection in people with Osteo Arthritis Knee, run by Istituto Ortopedico Rizzoli at 2 sites in Italy.
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 8 inclusion and 15 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 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. 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 Davide Reale, MD (0516366567, davide.reale@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) (time frame: 12 months). 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 NCT06685120, which also lists 6 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 3 Feb 2026.