Patellofemoral OsteoarthritisNCT04937998
PRP Versus HA IN OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT
A study testing Autologous PRP injection and HA injection in people with Patellofemoral Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The aim of the study is to compare the 12-month clinical outcomes of patients with patellofemoral osteoarthritis undergoing infiltrative treatment with fresh PRP and HA Read more about this study
- Who is it for?
- Ages 30 to 65 years
- Conditions the study is for
- Patellofemoral Osteoarthritis
- What is being tested?
- Autologous PRP injection and HA injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 166 participants
- Where
- 1 siteItaly
- Study dates
- 26 Oct 2022to Sep 2026
- 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 30 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 30 and 65;
- Signs and symptoms of isolated patellofemoral osteoarthritis present in one or both knees;
- Radiographic signs of isolated patellofemoral osteoarthritis (according to Iwano et al stage 1-3 classification) or chondropathy (assessed on MRI) with K-L grade of the other compartments ≤ 2. [PMID: 2302884 - PMID: 27979409] ;
- Hemoglobin > 11 g/dl; Platelet count > 150,000 plt/mm3 (Recently performed CBC exam);
- No clinically significant electrocardiographic alterations (Recently performed ECG).
- 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 who have undergone intra-articular infiltration of another substance within the previous 6 months;
- Patients undergoing knee surgery within the previous 12 months;
- Patients with malignant neoplasms;
- Patients with rheumatic diseases;
- Patients with diabetes;
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- Patients with hematologic diseases (coagulopathies);
- Patients on anticoagulant-antiaggregant therapy;
- Patients with 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 which a 60 mL blood draw would be contraindicated;
- Patients with a recently performed blood test with Hb< 11 g/dl and Platelets < 150,000 plt/mm3.
- Previous treatment of patellar dislocation
- Iwano score of grade 4.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Alessandro Di Martino, MD contact
Italy1 site, 1 recruiting
- Recruiting
Istituto Ortopedico Rizzoli
Bologna
Alessandro Di Martino, MD, 6366567 ext. 051, alessandro.dimartino@ior.it
Roberta Licciardi, MSc, 6366567 ext. 051, roberta.licciardi@ior.it
About this study
Official title: THE USE OF FRESH PRP VS HA IN THE TREATMENT OF OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT Randomized Controlled Clinical Trial
The aim of the study is to compare the 12-month clinical outcomes of patients with patellofemoral osteoarthritis undergoing infiltrative treatment with fresh PRP and HA
Read the detailed description
166 patients affected by patellofemoral osteoarthritis will be included in a double-blinded RCT. In this study one group of patients will be treated with 1 intra-articular injection of PRP (treatment arm) and one group will be treated with 1 intra-articular injection of HA (control arm). Patients will be followed-up with clinical evaluation at baseline and at 2.6.12 and 24 months. Questionnaires will be administered for clinical evaluations during the follow-up visits.
- Conditions
- Patellofemoral Osteoarthritis
- Being tested
- Autologous PRP injection, HA injection
- Keywords
- PRP, HA, Osteoarthritis, Autologous PRP, PRP injection, HA injection, injection treatment, Randomized controlled trial, Hyaluronic Acid, Platelet rich plasma
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous PRP injectionProcedure or surgery
Patients will be treated with a single injection of Autologous PRP (5 ml) in the knee joint affected by patellofemoral osteoarthritis
HA injectionProcedure or surgery
Patients will be treated with a single injections of Hyaluronic Acid (5 ml) in the knee joint affected by patellofemoral osteoarthritis
| Study group | Role | What they receive |
|---|---|---|
| Autologous PRP injection | Experimental | This group of patients will be treated with single intra-articular injection of Autologous PRP. Receives: Procedure: Autologous PRP injection |
| HA injection | Active comparator | This group of patients will be treated with single intra-articular injection of Hyaluronic Acid (HA) Receives: Procedure: HA injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
KOOS-Pain Score
KOOS-Pain Score is referred to a subscale of pain composed by 9 items. The score range considerate is 0-100.The score uses a 5-point Likert scale and each question is assigned a score from 0 to 4, where 0 indicates "no pain" and 4 "severe level of pain".
Measured: 12 months
Secondary outcomes (10)
IKDC-Subjective Score
This is a subjective, knee-specific rating scale that is considered one of the most reliable assessment tools in the evaluation of knee pathologies. All questions examines 3 categories: symptoms, sports activity, and knee function.
Measured: baseline, 2 month, 6 months, 12 months , 24 months follow-up
KOOS-Pain Score
KOOS-Pain Score is referred to a subscale of pain composed by 9 items. The score range considerate is 0-100.The score uses a 5-point Likert scale and each question is assigned a score from 0 to 4, where 0 indicates "no pain" and 4 "severe level of pain".
Measured: baseline, 2 month, 6 months , 24 months follow-up
Visual Analogue Scale (VAS)
VAS is a visual analogue scale consisting of a range scale (10 cm length), the ends of which correspond to "no pain" and "the strongest pain imaginable".
Measured: baseline, 2 month, 6 months, 12 months , 24 months follow-up
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, 2 month, 6 months, 12 months , 24 months follow-up
EQ-5D (EuroQoL) Current Health Assessment
EQ-5D is useful to evaluate the quality life of the patients
Measured: baseline, 2 month, 6 months, 12 months , 24 months follow-up
Tegner Activity Level Scale
Tegner activity level scale allows to know the level of physical activity carried out by the patients. All patients will indicate the type of sporting activity performed and its frequency.
Measured: baseline, 2 month, 6 months, 12 months , 24 months follow-up
Objective parameters- Range of Motion
Evaluation of the Range of Motion for comparative analysis.
Measured: baseline, 2 month, 6 months, 12 months , 24 months follow-up
Objective parameters - Circumferences
Bilateral trans- and supra- patellar circumferences measurement for comparative analysis
Measured: baseline, 2 month, 6 months, 12 months , 24 months follow-up
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, 2 month, 6 months, 12 months , 24 months follow-up
The Kujala Anterior Knee Pain Scale (AKPS)
It's a 100-point scale consisting of 13 items with a score ranging from 5 to 10 points per item. A score of 0 points indicates the most severe limitation, while a score of 100 points indicates a normal situation.
Measured: baseline, 2 month, 6 months, 12 months , 24 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start26 Oct 2022
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Patellofemoral OsteoarthritisStudies 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
- The study is a double-blinded RCT in which one group of patients will be treated with 1 intra-articular injection of fresh PRP, and one group will be treated with 1 intra-articular injection of HA.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 166 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alessandro Di Martino, MD, Principal investigator, Istituto Ortopedico Rizzoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937998
- Sponsor's protocol ID
- PRP-21
- Status last verified
- Dec 2025
- First submitted
- 18 Jun 2021
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Di Martino A, Di Matteo B, Papio T, Tentoni F, Selleri F, Cenacchi A, Kon E, Filardo G. Platelet-Rich Plasma Versus Hyaluronic Acid Injections for the Treatment of Knee Osteoarthritis: Results at 5 Years of a Double-Blind, Randomized Controlled Trial. Am J Sports Med. 2019 Feb;47(2):347-354. doi: 10.1177/0363546518814532. Epub 2018 Dec 13.
PubMed 30545242Everts PA, Knape JT, Weibrich G, Schonberger JP, Hoffmann J, Overdevest EP, Box HA, van Zundert A. Platelet-rich plasma and platelet gel: a review. J Extra Corpor Technol. 2006 Jun;38(2):174-87.
PubMed 16921694Cavallo C, Filardo G, Mariani E, Kon E, Marcacci M, Pereira Ruiz MT, Facchini A, Grigolo B. Comparison of platelet-rich plasma formulations for cartilage healing: an in vitro study. J Bone Joint Surg Am. 2014 Mar 5;96(5):423-9. doi: 10.2106/JBJS.M.00726.
PubMed 24599205deDeugd CM, Pareek A, Krych AJ, Cummings NM, Dahm DL. Outcomes of Patellofemoral Arthroplasty Based on Radiographic Severity. J Arthroplasty. 2017 Apr;32(4):1137-1142. doi: 10.1016/j.arth.2016.11.006. Epub 2016 Nov 15.
PubMed 27979409Assirelli E, Filardo G, Mariani E, Kon E, Roffi A, Vaccaro F, Marcacci M, Facchini A, Pulsatelli L. Effect of two different preparations of platelet-rich plasma on synoviocytes. Knee Surg Sports Traumatol Arthrosc. 2015 Sep;23(9):2690-703. doi: 10.1007/s00167-014-3113-3. Epub 2014 Jun 19.
PubMed 24942296
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE USE OF FRESH PRP VS HA IN THE TREATMENT OF OSTEOARTHRITIS OF THE PATELLOFEMORAL JOINT Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04937998
- Acronym / sponsor ID
- PRP-21
- Conditions
- Patellofemoral Osteoarthritis
- Keywords
- PRP, HA, Osteoarthritis, Autologous PRP, PRP injection, HA injection, injection treatment, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 166 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 26 Oct 2022 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 24 Jun 2021 (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 the study is to compare the 12-month clinical outcomes of patients with patellofemoral osteoarthritis undergoing infiltrative treatment with fresh PRP and HA
Detailed description
166 patients affected by patellofemoral osteoarthritis will be included in a double-blinded RCT. In this study one group of patients will be treated with 1 intra-articular injection of PRP (treatment arm) and one group will be treated with 1 intra-articular injection of HA (control arm). Patients will be followed-up with clinical evaluation at baseline and at 2.6.12 and 24 months. Questionnaires will be administered for clinical evaluations during the follow-up visits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a double-blinded RCT in which one group of patients will be treated with 1 intra-articular injection of fresh PRP, and one group will be treated with 1 intra-articular injection of HA.
| Arm | Type | Receives |
|---|---|---|
| Autologous PRP injection | Experimental | Procedure: Autologous PRP injectionThis group of patients will be treated with single intra-articular injection of Autologous PRP. |
| HA injection | Active comparator | Procedure: HA injectionThis group of patients will be treated with single intra-articular injection of Hyaluronic Acid (HA) |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 30 and 65;
- Signs and symptoms of isolated patellofemoral osteoarthritis present in one or both knees;
- Radiographic signs of isolated patellofemoral osteoarthritis (according to Iwano et al stage 1-3 classification) or chondropathy (assessed on MRI) with K-L grade of the other compartments ≤ 2. [PMID: 2302884 - PMID: 27979409] ;
- Hemoglobin > 11 g/dl; Platelet count > 150,000 plt/mm3 (Recently performed CBC exam);
- No clinically significant electrocardiographic alterations (Recently performed ECG).
Key exclusion criteria (16 listed)
- Patients unable to express consent;
- Patients who have undergone intra-articular infiltration of another substance within the previous 6 months;
- Patients undergoing knee surgery within 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 |
|---|---|---|
| Autologous PRP injectionPatients will be treated with a single injection of Autologous PRP (5 ml) in the knee joint affected by patellofemoral osteoarthritis | Procedure or surgery | Autologous PRP injection |
| HA injectionPatients will be treated with a single injections of Hyaluronic Acid (5 ml) in the knee joint affected by patellofemoral osteoarthritis | Procedure or surgery | HA injection |
Primary outcome
KOOS-Pain Score
Time frame: 12 months
KOOS-Pain Score is referred to a subscale of pain composed by 9 items. The score range considerate is 0-100.The score uses a 5-point Likert scale and each question is assigned a score from 0 to 4, where 0 indicates "no pain" and 4 "severe level of pain".
10 secondary outcomes
IKDC-Subjective Score
Time frame: baseline, 2 month, 6 months, 12 months , 24 months follow-up
KOOS-Pain Score
Time frame: baseline, 2 month, 6 months , 24 months follow-up
Visual Analogue Scale (VAS)
Time frame: baseline, 2 month, 6 months, 12 months , 24 months follow-up
EQ-VAS
Time frame: baseline, 2 month, 6 months, 12 months , 24 months follow-up
EQ-5D (EuroQoL) Current Health Assessment
Time frame: baseline, 2 month, 6 months, 12 months , 24 months follow-up
Tegner Activity Level Scale
Time frame: baseline, 2 month, 6 months, 12 months , 24 months follow-up
Objective parameters- Range of Motion
Time frame: baseline, 2 month, 6 months, 12 months , 24 months follow-up
Objective parameters - Circumferences
Time frame: baseline, 2 month, 6 months, 12 months , 24 months follow-up
Patient Acceptable Symptom State (PASS)
Time frame: baseline, 2 month, 6 months, 12 months , 24 months follow-up
The Kujala Anterior Knee Pain Scale (AKPS)
Time frame: baseline, 2 month, 6 months, 12 months , 24 months follow-up
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 4 Dec 2025.
- Background: PubMed 30545242Di Martino A, Di Matteo B, Papio T, Tentoni F, Selleri F, Cenacchi A, Kon E, Filardo G. Platelet-Rich Plasma Versus Hyaluronic Acid Injections for the Treatment of Knee Osteoarthritis: Results at 5 Years of a Double-Blind, Randomized Controlled Trial. Am J Sports Med. 2019 Feb;47(2):347-354. doi: 10.1177/0363546518814532. Epub 2018 Dec 13.
- Background: PubMed 16921694Everts PA, Knape JT, Weibrich G, Schonberger JP, Hoffmann J, Overdevest EP, Box HA, van Zundert A. Platelet-rich plasma and platelet gel: a review. J Extra Corpor Technol. 2006 Jun;38(2):174-87.
- Background: PubMed 24599205Cavallo C, Filardo G, Mariani E, Kon E, Marcacci M, Pereira Ruiz MT, Facchini A, Grigolo B. Comparison of platelet-rich plasma formulations for cartilage healing: an in vitro study. J Bone Joint Surg Am. 2014 Mar 5;96(5):423-9. doi: 10.2106/JBJS.M.00726.
- Background: PubMed 27979409deDeugd CM, Pareek A, Krych AJ, Cummings NM, Dahm DL. Outcomes of Patellofemoral Arthroplasty Based on Radiographic Severity. J Arthroplasty. 2017 Apr;32(4):1137-1142. doi: 10.1016/j.arth.2016.11.006. Epub 2016 Nov 15.
- Background: PubMed 24942296Assirelli E, Filardo G, Mariani E, Kon E, Roffi A, Vaccaro F, Marcacci M, Facchini A, Pulsatelli L. Effect of two different preparations of platelet-rich plasma on synoviocytes. Knee Surg Sports Traumatol Arthrosc. 2015 Sep;23(9):2690-703. doi: 10.1007/s00167-014-3113-3. Epub 2014 Jun 19.
- 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.
Alessandro Di Martino, MD contact
Alessandro Di Martino, MD principal investigator
Istituto Ortopedico Rizzoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous PRP injection and HA injection in people with Patellofemoral Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site 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 7 inclusion and 16 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 4 Dec 2025. 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 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 Roberta Licciardi, MSc (0516366567, roberta.licciardi@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KOOS-Pain Score (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 NCT04937998, which also lists 5 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 4 Dec 2025.