Could a Two-In-One injection ease knee arthritis pain?

NCT ID NCT06685120

Symptom relief Sponsor: Istituto Ortopedico Rizzoli Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether a combination of platelet-rich plasma (PRP) and hyaluronic acid injections works better than either treatment alone for knee osteoarthritis. About 288 adults aged 40 to 75 with knee pain will receive one of three treatments. The goal is to see if the combo reduces pain, stiffness, and improves daily function.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Platelet-rich plasma (PRP) and hyaluronic acid injection
What this could lead to: If it works, this could offer a more effective non-surgical option to reduce pain and improve knee function in people with osteoarthritis.
What could go wrong: This is an early-stage trial with no phase designation, so results are uncertain. The benefit over existing treatments may be small, and injections carry risks like infection or joint pain.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 288 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Sep 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Male or female patients, aged 40 to 75 years; 2. Patients with symptomatic knee osteoarthritis (VAS pain score between ≥ 3 and ≤ 8); 3. Unilateral involvement of symptomatology; 4. Radiographic or MRI signs of degenerative pathology of knee cartilage (Kellgren-Lawrence grade 1-3); 5. Failure, defined as the persistence of symptomatology, after at least one course of conservative treatment (pharmacological, physiotherapeutic or infiltrative treatment); 6. Hemoglobin \> 11 g/dl; Platelet count \> 150,000 plt/mm3 (Recently performed CBC examination); 7. Ability and consent of patients to actively participate in clinical follow-up; 8. Signature of informed consent. Exclusion Criteria: 1. Patients unable to express consent; 2. Patients undergoing intra-articular infiltration of other substance in the previous 6 months; 3. Patients undergoing knee surgery in the previous 12 months; 4. Patients with malignant neoplasms; 5. Patients with rheumatic diseases; 6. Patients with uncontrolled diabetes; 7. Patients with hematological diseases (coagulopathies); 8. Patients on anticoagulant-antiaggregant therapy that cannot be discontinued at the time of blood collection; 9. Patients with uncompensated thyroid metabolic disorders; 10. Patients abusing alcoholic beverages, drugs or medications; 11. Body Mass Index \> 35; 12. Patients who have taken NSAIDs in the 3 days prior to blood draw; 13. Patients with cardiovascular disease for whom blood sampling 30 to 60 ml would be contraindicated; 14. Patients with recently performed CBC examination with Hb\< 11 g/dl and Platelet values \< 150,000 plt/mm3. 15. Pregnant and/or fertile women.

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Conditions

The condition(s) this trial relates to.

osteoarthritis, knee

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Osteo arthritis knee

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

2 sites. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Could a Two-In-One injection ease knee arthritis pain?

What the study statuses mean