Knee Osteoarthritis Clinical Trial
Official title:
A Prospective, Multicenter, Randomized,Controlled Study to Compare the Safety and Performance of Cellular Matrix Device (Combination of Autologous Platelet-rich Plasma and Non-crosslinked Hyaluronic Acid) to Those of Synvisc-One (Crosslinked Hyaluronic Acid) for the Treatment of Mild to Moderate Knee Osteoarthritis
This is a non-inferiority study on 190 patients to evaluate whether a treatment based on the combination of autologous platelet-rich plasma and hyaluronic acid obtained with Cellular Matrix represents a therapeutic advantage to relieve symptoms associated with a mild to moderate knee osteoarthritis (particularly pain on walking) compared to hyaluronic acid only (Synvisc®-One).
Status | Recruiting |
Enrollment | 190 |
Est. completion date | March 31, 2021 |
Est. primary completion date | March 31, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 50 Years to 80 Years |
Eligibility |
Inclusion Criteria: - femorotibial knee osteoarthritis defined according to the American College of Rheumatology (ACR) criteria - Symptomatic knee osteoarthritis of a unilateral knee, characterized by pain at walking (WOMAC A1 score assessed over the previous 24 hours on a 100-mm Visual Analog Scale (VAS): 50 = WOMAC A1 = 90) or reduced joint function (total WOMAC C score assessed or over the previous 24 hours on a 100-mm VAS: 50 = WOMAC A1 = 90) - Bilateral knee osteoarthritis is allowed, provided the contralateral knee is characterized by a maximum pain of 30 on a 0 to 100 mm scale and doesn't require systemic analgesic treatment, with the exception of paracetamol up to the maximum dose of 4 g per day - Radiographic femorotibial knee osteoarthritis (radiograph not older than 3 months) Kellgren & Lawrence grades of II-III - Outpatient capable of walking 50 meters without assistance - Signature of the informed consent form - Capable of understanding the study's imperatives, as well as written instructions - Capable of filling-out evaluation questionnaires Exclusion Criteria: - Radiographic femoro-tibial knee osteoarthritis Kellgren & Lawrence grades of I or IV - Bilateral knee osteoarthritis, characterized by pain greater than 30 of both knees evaluated on a 0 to 100-mm scale and requiring systemic analgesic treatment or paracetamol greater than 4g/ day - Viscosupplementation in the past 3 months - Corticosteroid injection in the past 3 months - PRP or PRP/HA injection in the past 12 months - Any surgery of the knee planned during the next 6 months - Systematic use of corticosteroids (except those that are inhaled) or level III analgesics in the past 3 months and NSAID (non-steroidal anti-inflammatory drugs) during the past month - Treatment with slow-acting anti-rheumatic drugs (diacerhein, soybean or avocado unsaponifiables, chondroitin sulfate, glucosamine) started in the past 6 months - History of allergy to hyaluronic acid - Auto-immune disease (rheumatoid arthritis, lupus) - Surgery of the affected knee in the past 3 months - Infection of the affected knee in the past 6 months - Rheumatologic disorder other than arthritis - Clinical evidence of local inflammation such as redness or heat of the joint - Hereditary or acquired hematologic or clotting disorders, such as drepanocytosis, platelet dysfunction, thrombocytopenia (<150'000 platelets/mm3), etc. - Anemia (Hemoglobin < 10g/dl) - Anticoagulant treatment (patients under antiaggregant treatment can take part to this study as long as their clotting time (CT) is within the reference value) - Acute infection - Malignant disease (especially bone and hematological - serious disorders (cardiovascular pathology, active gastroduodenal ulcer, digestive hemorrhage) - Patient with renal impairment (creatinine clearance below 45 ml / min) - Patient with liver failure, pending or who have recently received a liver transplant - Pregnancy or breastfeeding or planning pregnancy during the course of the study - Immunosuppression - Insulin-dependent diabetic patient - Participation ongoing or in the past 3 months in another clinical study - Participation to another osteoarthritis clinical study during the past year - Patient unable to submit to the constraints of the protocol, including patient whose mental condition does not allow him to understand the nature, objectives and possible consequences of the study - Any other reason which, in the opinion of the investigator, may interfere with the proper conduct of the study |
Country | Name | City | State |
---|---|---|---|
France | Clinique Médipôle garonne | Toulouse | Haute-Garonne |
Lead Sponsor | Collaborator |
---|---|
Regen Lab SA |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from Baseline pain on walking (Western Ontario & McMaster Universities [WOMAC] A1 of the WOMAC questionaire) at 6 months | For each group, pain on walking will be evaluated using a 100-mm Visual Analog Scale (VAS), where 0= no pain and 100 = extreme pain | 6 months | |
Secondary | Change from Baseline pain on walking at 1 and 3 months | For each group, pain on walking will be evaluated using a 100-mm Visual Analog Scale (VAS), where 0= no pain and 100 = extreme pain | 1 and 3 months | |
Secondary | Change from Baseline overall knee osteoarthritis symptoms at 1, 3 and 6 Months | For each group, overall knee osteoarthritis will be evaluated using the total WOMAC questionnaire; each item of this questionnaire will be scored using a 100-mm VAS at baseline, Month 1, Month 3, and Month 6. The total WOMAC score will be reported as a summed score of all items of the questionnaire, with 0 is the minimum and 2400 is the maximum. | 1, 3 and 6 months | |
Secondary | Change from Baseline pain at 1, 3 and 6 Months | For each group, pain will be evaluated using the WOMAC A subscale; each item of this subscale will be scored using a 100-mm VAS at baseline, Month 1, Month 3, and Month 6. The total WOMAC A score will be reported as a summed score of all items of this subscale, where 0 = is the minimum (no pain) and 500 is the maximum (extreme pain). | 1, 3 and 6 months | |
Secondary | Change from Baseline stiffness at 1, 3 and 6 Months | For each group, stiffness will be evaluated using the WOMAC B subscale; each item of this subscale will be scored using a 100-mm VAS at baseline, Month 1, Month 3, and Month 6. The total WOMAC B score will be reported as a summed score of all items of this subscale, where 0 = is the minimum (no stiffness) and 200 is the maximum (extreme stiffness). | 1, 3 and 6 months | |
Secondary | Change from Baseline physical function at 1, 3 and 6 Months | For each group, physical function will be evaluated using the WOMAC C subscale; each item of this subscale will be scored using a 100-mm VAS at baseline, Month 1, Month 3, and Month 6. The total WOMAC C score will be reported as a summed score of all items of this subscale, where 0 = is the minimum (no difficulty to perform activities) and 1700 is the maximum (extreme difficulty to perform activities). | 1, 3 and 6 months | |
Secondary | Change from Baseline quality of life at all time points | Quality of life will be assessed using the 36-Item Short Form (SF-36) survey that will be given to patients at each visit throughout the study. | 1, 3 and 6 months | |
Secondary | Patient Global Assessment of the treatment received | Patient Global Assessment will be performed using a 5-point numeric scale at 1, 3 and 6 Months, with 1 = completely dissatisfied, 2= dissatisfied, 3 = no change, 4=satisfied , 5= completely satisfied | 1, 3 and 6 months | |
Secondary | Clinician Global Assessment of the treatment received | Patient Global Assessment will be performed using a 5-point numeric scale at 1, 3 and 6 Months, 1 = completely dissatisfied, 2= dissatisfied, 3 = no change, 4=satisfied , 5= completely satisfied | 1, 3 and 6 months | |
Secondary | Percentage of OMERACT-OARSI (Outcome Measure in Rheumatology - Osteoarthitis Research Society International) responders at 1, 3 and 6 Months | 1, 3 and 6 months | ||
Secondary | Percentage of patients requiring an injection of the combination of PRP/HA prepared with Cellular Matrix / A-CP HA at 6 Months | 6 months | ||
Secondary | Number of local and systemic side effects throughout the study period | 6 months | ||
Secondary | Cartilage structure | The cartilage structure will be evaluated on the basis of Magnetic Resonance Imaging (MRI) assays at baseline (before receiving the treatment) and 6 months. Differences on the T1 relaxation time parameter will be evaluated at different time points. | 6 months | |
Secondary | Rescue treatment consumption at 1, 3 and 6 Months | Consumption of authorized medication to relieve pain, according to the patient's diary | 1, 3 and 6 months |
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