Knee OsteoarthritisNCT06483269
Homologus PRP in the Infiltrative Treatment of Knee Osteoarthritis in Young Athletic Patients
A study testing PRP infiltration in people with Knee Osteoarthritis, run by Istituto Ortopedico Rizzoli at 1 site in Italy.
Trial summary
The study consists of 3 phases (enrollment, infiltrative procedure, and controls): Identification by specialized orthopedic medical staff belonging to the SC Orthopedic and Trauma Clinic II of the Rizzoli Orthopedic Institute of subjects who meet the study inclusion criteria. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- PRP infiltration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 10 Oct 2023to 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 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients, both sexes, with symptomatic knee osteoarthritis with:
- Age: 18-40 years;
- Unilateral involvement;
- Signs and symptoms of knee osteoarthritis;
- Radiographic or MRI signs of degenerative pathology of knee cartilage (Kellgren-Lawrence grade 1-3);
- Ability and consent of patients to actively participate in clinical follow-up;
- Signature of informed consent;
- Pain ≥ 4 on VAS s
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 metabolic diseases;
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- Patients with hematological diseases (coagulopathies);
- Patients abusing alcoholic beverages, drugs or medications;
- Knee trauma treated in the previous 6 months.
- Other conditions that may interfere with the evaluation of OA treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS - Istituto ortopedico Rizzoli
Bologna, 40136
Mirco Lo Presti, MD, 0516366 ext. 084, mirco.lopresti@ior.it
About this study
The study consists of 3 phases (enrollment, infiltrative procedure, and controls):
- Identification by specialized orthopedic medical staff belonging to the SC Orthopedic and Trauma Clinic II of the Rizzoli Orthopedic Institute of subjects who meet the study inclusion criteria. Signing of informed consent form and completion of evaluation questionnaires.
- infiltrative procedure
- Patients will be clinically evaluated before the infiltration procedure and at 1, 3, 6, and 12 months after treatment by trained medical personnel (outcome assessors). Questionnaires will be administered for clinical evaluations before treatment and at these clinical checkups during follow-up. Any adverse events to treatment will also be assessed during follow-up visits. The duration and extent of joint swelling and pain following infiltration will be reported, and any drug therapies taken by the patient will be recorded.
- Conditions
- Knee Osteoarthritis
- Being tested
- PRP infiltration
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP infiltrationProcedure or surgery
a single intra-articular infiltration of 5 mL of PRP-O will be performed by the infiltrating physician.
It is specified that the PRP-O used within the study will be produced following the guidelines and standards for the production of blood products for non-transfusion use as already in place at the Unified Metropolitan Transfusion Service IOR site.
PRP (Platelet Rich Plasma) is produced from platelet pool from donor buffy coat.
PRP contains 1,000,000 PLT/mml +/- 20%, as required by current regulations.
| Study group | Role | What they receive |
|---|---|---|
| infiltrative procedure | Other | Not described Receives: Procedure: PRP infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Knee Documentation Committee score
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.
Measured: 6 months
Secondary outcomes (8)
International Knee Documentation Committee score
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.
Measured: baseline, 1, 3, 6, 12 months
Tegner Activity Level Scale
It is a questionnaire to find out the patient's level of physical activity
Measured: baseline, 1, 3, 6, 12 months
Knee Injury and Osteoarthritis Outcome Score
The full questionnaire consists of five subscales and they cover: pain (9 items), symptoms (7 items of which two relate to stiffness), functions and activities of daily living (17 items) physical function, sports activities and leisure (5 items) and quality of life in relation to the knee (4 items). All items in the relevant subscales have the same response mode, use a 5-point Likert scale, and each question is assigned a score from 0 to 4, where 0 indicates "no difficulty" and 4 "a severe difficulty). Score range 0-100 for each subscale.
Measured: baseline, 1, 3, 6, 12 months
Visual Analogue Scale
visual analog scale consisting of a straight line segment (10 cm length), the ends of which correspond to "no pain" and "the strongest pain imaginable"
Measured: baseline, 1, 3, 6, 12 months
objective parameter
range of motion and bilateral trans patellar and supra patellar circumferences for comparative analysis.
Measured: baseline, 1, 3, 6, 12 months
Patient Acceptable Symptom State
Valuable tool for assessing patient satisfaction considering the patient's current degree of pain, function, and daily activity.
Measured: baseline, 1, 3, 6, 12 months
Expectations of treatment efficacy
The patient should indicate at baseline what benefits he or she expects from the treatment.
Measured: baseline
Overall judgment on treatment
The patient should indicate the degree of satisfaction related to the treatment performed at each follow-up.
Measured: baseline, 1, 3, 6, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start10 Oct 2023
- 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 (2)Papers the sponsor has linked to this study.
- Other trials for Knee 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Ortopedico Rizzoli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06483269
- Sponsor's protocol ID
- PRP-Sport Pilot
- Status last verified
- Jul 2025
- First submitted
- 21 Jun 2024
- Last updated
- 4 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Everts 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 16921694Sanchez AR, Sheridan PJ, Kupp LI. Is platelet-rich plasma the perfect enhancement factor? A current review. Int J Oral Maxillofac Implants. 2003 Jan-Feb;18(1):93-103.
PubMed 12608674
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Homologus PRP in the Infiltrative Treatment of Knee Osteoarthritis in Young Athletic Patients
- ClinicalTrials.gov ID
- NCT06483269
- Acronym / sponsor ID
- PRP-Sport Pilot
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Istituto Ortopedico RizzoliUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 3 Jul 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.
The study consists of 3 phases (enrollment, infiltrative procedure, and controls):
- Identification by specialized orthopedic medical staff belonging to the SC Orthopedic and Trauma Clinic II of the Rizzoli Orthopedic Institute of subjects who meet the study inclusion criteria. Signing of informed consent form and completion of evaluation questionnaires.
- infiltrative procedure
- Patients will be clinically evaluated before the infiltration procedure and at 1, 3, 6, and 12 months after treatment by trained medical personnel (outcome assessors). Questionnaires will be administered for clinical evaluations before treatment and at these clinical checkups during follow-up. Any adverse events to treatment will also be assessed during follow-up visits. The duration and extent of joint swelling and pain following infiltration will be reported, and any drug therapies taken by the patient will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| infiltrative procedure | Other | Procedure: PRP infiltration |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients, both sexes, with symptomatic knee osteoarthritis with:
- Age: 18-40 years;
- Unilateral involvement;
- Signs and symptoms of knee osteoarthritis;
- Radiographic or MRI signs of degenerative pathology of knee cartilage (Kellgren-Lawrence grade 1-3);
Key exclusion criteria (10 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 infiltrationa single intra-articular infiltration of 5 mL of PRP-O will be performed by the infiltrating physician. It is specified that the PRP-O used within the study will be produced following the guidelines and standards for the production of blood products for non-transfusion use as already in place at the Unified Metropolitan Transfusion Service IOR site. PRP (Platelet Rich Plasma) is produced from platelet pool from donor buffy coat. PRP contains 1,000,000 PLT/mml +/- 20%, as required by current regulations. | Procedure or surgery | infiltrative procedure |
Primary outcome
International Knee Documentation Committee score
Time frame: 6 months
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.
8 secondary outcomes
International Knee Documentation Committee score
Time frame: baseline, 1, 3, 6, 12 months
Tegner Activity Level Scale
Time frame: baseline, 1, 3, 6, 12 months
Knee Injury and Osteoarthritis Outcome Score
Time frame: baseline, 1, 3, 6, 12 months
Visual Analogue Scale
Time frame: baseline, 1, 3, 6, 12 months
objective parameter
Time frame: baseline, 1, 3, 6, 12 months
Patient Acceptable Symptom State
Time frame: baseline, 1, 3, 6, 12 months
Expectations of treatment efficacy
Time frame: baseline
Overall judgment on treatment
Time frame: baseline, 1, 3, 6, 12 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 4 Jul 2025.
- Results publication: 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.
- Results publication: PubMed 12608674Sanchez AR, Sheridan PJ, Kupp LI. Is platelet-rich plasma the perfect enhancement factor? A current review. Int J Oral Maxillofac Implants. 2003 Jan-Feb;18(1):93-103.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP infiltration in people with Knee 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 8 inclusion and 10 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 Jul 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 Mirco Lo Presti, MD (0516366 ext. 084, mirco.lopresti@ior.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Knee Documentation Committee score (time frame: 6 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 NCT06483269, which also lists 2 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 Jul 2025.