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One-Shot knee injection could ease arthritis pain
NCT ID NCT05727371
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a single injection of a mix of platelet-rich plasma (from your own blood) and hyaluronic acid can safely reduce pain and improve function in people with moderate to severe knee osteoarthritis. About 280 adults with grade 3-4 knee arthritis will receive either the new combination, a standard treatment, or a placebo. The goal is to see if this approach offers better symptom relief than current options.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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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
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About 280 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2023
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 90 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * Tibiofemoral knee osteoarthrosis according to ACR criteria * Tibiofemoral knee osteoarthrosis grade 3-4 according to the Kellgren \& Lawrence grading scale, as defined on knee radiographs (less than 3 months old: face view, schuss view, profile and patellar axial view at 30°) * Symptomatic knee osteoarthrosis as evidenced by pain on walking (WOMAC A1 assessed in the last 24 hours on a scale of 0 to 100 mm: 50 ≤ DM 90 or reduced joint function (WOMAC C total score assessed or within the previous 24 hours based on a scale of 0-100-mm: 50 ≤ WOMAC C ≤ 90) * Patient able to understand the requirements of the trial and who has signed a free and informed consent prior to study entry * Patient able to read and understand the written instructions * Patient able to complete the self-assessment questionnaires Exclusion Criteria: * Tibiofemoral knee osteoarthrosis grade I or II according to the Kellgren and Lawrence grading scale * Knee surgery planned in the next 6 months * Patient affected by autoimmune disease (rheumatoid arthritis, lupus, Hashimoto's disease and Bechterew's syndrome) * Chronic inflammatory rheumatism other than arthritis (polyarthrosis, etc.) * Patient affected by a knee infection in the past 6 months * Clinical signs of local knee inflammation (redness or warmth of the knee joint) * Last PRP or PRP/HA injection received in the last year * Last viscosupplementation received in the past 6 months * Last corticosteroid injection received in the past 3 months * Use of gluco-corticosteroids (except inhaled) and level III analgesics in the last 3 months and non-steroidal anti-inflammatory drug in the last 2 weeks * Treatment with AAAL initiated within the last 6 months * History of allergy to hyaluronic acid * Hematologic or clotting disorders (thrombocytopenia) or blood coagulation (deficit-blood dyscrasia) * Patients with coagulation times outside the reference values * Anemia (HGB\<10 g/dl) * Venous or lymphatic stasis in the corresponding limb * Malignant diseases (especially bone or haematological) * Patients with serious, no-stabilized pathologies (cardiovascular disease, active peptic ulcer, digestive hemorrhage) * Acute infection * Patients with cancer or with an immuno-deprassant treatment ongoing * Participation in another clinical trial for osteoarthritis of the knee in the last year * Participation in another clinical trial, ongoing or completed within the last 3 months * Patient unable to comply with the constraints of the protocol, in particular a patient whose mental state does not allow him/her to patient's mental state does not allow him/her to understand the nature, objectives and possible consequences of the study * Pregnant or breastfeeding women or women who expect to become pregnant during the study * Any other reason which may interfere with the proper conduct of the study, in the investigator's opinion
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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CHU Henri Mondor APHP
Créteil, France
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CHU Limoges
Limoges, France
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CHU Nantes Hôtel - Dieu
Nantes, France
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Centre Hospitalier Départemental Vendée
La Roche-sur-Yon, France
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Centre Hospitalier Lyon Sud
Lyon, France
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Centre Hospitalier Sud-Francilien
Corbeil-Essonnes, France
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Ch de Narbonne
Narbonne, France
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Clinique Medipole Garonne, Radiologie Interventionnelle 45 Rue Gironis
Toulouse, 31100, France
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Hopital Lapeyronie
Montpellier, 34295, France
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Hopital Le Bocage Chru
Dijon, DE, 21079, France
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Hopital Maison Blanche
Reims, 51092, France
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Hôpital Lariboisière
Paris, France
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Hôpital Saint-Antoine
Paris, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a shot of your own blood ease arthritic knees?
- 5,000 knee arthritis patients tracked to crack the treatment code
- Can a hydrogel injection ease knee arthritis pain?
- Weekly shot aims to melt away pounds in obesity fight
- Can shockwave plus injections quiet knee arthritis pain?