Status:
UNKNOWN
Cellular Matrix Device for the Treatment of Mild to Moderate Knee Osteoarthritis
Lead Sponsor:
Regen Lab SA
Conditions:
Knee Osteoarthritis
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief Summary
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...
Detailed Description
Platelet-rich plasma (PRP) is an autologous product prepared from the patient's own blood, representing a powerful source of platelet-derived growth factors, particularly useful in the field of regene...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 18 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2021
Estimated Enrollment :
190 Patients enrolled
Trial Details
Trial ID
NCT03328728
Start Date
July 18 2017
End Date
March 31 2021
Last Update
November 14 2019
Active Locations (1)
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1
Clinique Médipôle garonne
Toulouse, Haute-Garonne, France, 31036