Combination of PRP and XLHA Prepared With RegenMatrix Medical Device To Treat Moderate to Severe Knee Osteoarthritis
NCT ID: NCT05727371
Last Updated: 2023-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
280 participants
INTERVENTIONAL
2023-08-21
2025-08-21
Brief Summary
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Detailed Description
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The symptomatic benefit will be evaluated in terms of pain reduction and improvement of patient's quality of life. The functional benefit of the treatment will also be evaluated, on a reduced number of participants, by a gait analysis, performed only in the coordinating centre.
The medical device RegenMatrix is an adaptation of the medical device Cellular Matrix (certified since 2013,CE2797). It differs from the latter only for by presence of cross-linked HA instead of linear HA, and is therefore particularly suitable for the treatment of moderate to severe knee osteoarthritis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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RegenMatrix-PRP-XLHA
Patients randomized in this group will receive a single injection of a combination of platelet-rich plasma plus cross-linked hyaluronic acid, prepared with the medical device RegenMatrix.
Regen Matrix-PRP-XLHA
Single intra-articular injection at Day 0
Hylan G-F 20
Patients randomized in this group will receive a single injection of cross-linked hyaluronic acid Hylan G-F 20 (Synvisc-One®).
Hylan G-F 20
Single intra-articular injection at Day 0
Placebo
Patients randomized in this group will receive a single injection of saline solution (0.9% NaCl)
Placebo
Single intra-articular injection at Day 0
Interventions
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Regen Matrix-PRP-XLHA
Single intra-articular injection at Day 0
Hylan G-F 20
Single intra-articular injection at Day 0
Placebo
Single intra-articular injection at Day 0
Eligibility Criteria
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Inclusion 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
* 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
40 Years
90 Years
ALL
No
Sponsors
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RegenLab France SAS
INDUSTRY
Responsible Party
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Principal Investigators
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Paul Ornetti, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire Dijon
Locations
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Hopital Le Bocage Chru
Dijon, DE, France
Hopital Lapeyronie
Montpellier, , France
Clinique Medipole Garonne, Radiologie Interventionnelle 45 Rue Gironis
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-A01514-39
Identifier Type: -
Identifier Source: org_study_id
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