Using a combination of PRP and cross-linked hyaluronic acid to treat knee osteoarthritis
Multicenter, Randomized Double-blind Study to Compare the Safety and Performance of a Combination of A-PRP and XLHA Prepared With the RegenMatrix Medical Device, to Hylan G-F 20 XLHA and Placebo to Treat Moderate/Severe Knee Osteoarthritis
This study is testing if a single injection that combines a special type of gel with your own blood can help people with moderate to severe knee osteoarthritis feel less pain and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 40 Years to 90 Years |
| Sex | All |
| Sponsor | Regen Lab SA Industry-sponsored |
| Locations | 3 sites (Dijon, DE and 2 other locations) |
| Trial ID | NCT05727371 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of a single injection combining cross-linked hyaluronic acid (HA) with autologous platelet-rich plasma (PRP) for patients with moderate to severe knee osteoarthritis. It is a multicenter, randomized, double-blind, three-arm study comparing the experimental treatment against a reference treatment and a placebo. The study will assess pain reduction and quality of life improvements at multiple time points, including Day 0, Month 1, Month 3, and Month 6. Additionally, a subset of participants will undergo gait analysis to evaluate functional benefits.
Who should consider this trial
Good fit: Ideal candidates are individuals with moderate to severe knee osteoarthritis (grade III-IV) who experience significant pain and reduced joint function.
Not a fit: Patients with mild knee osteoarthritis (grade I or II) or those planning knee surgery within the next six months may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly alleviate pain and improve the quality of life for patients suffering from knee osteoarthritis.
How similar studies have performed: Previous studies have shown promising results with similar approaches using PRP and hyaluronic acid, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Dijon, DE and 2 other locations
- Hopital Le Bocage Chru — Dijon, De, France (Recruiting)
- Hopital Lapeyronie — Montpellier, France (Recruiting)
- Clinique Medipole Garonne, Radiologie Interventionnelle 45 Rue Gironis — Toulouse, France (Recruiting)
Study contacts
- Principal investigator: Paul Ornetti, MD — Centre Hospitalier Universitaire Dijon
- Study coordinator: Bruno Boezennec, MD
- Email: bboezennec@regenlab.com
- Phone: +33 (0) 642 93 92 00
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.