osteoarthritis of the knee
Conditions
Interventions
Study group: EVA-001 implantation/HTO combination group
Control group: HTO monoperative group
Sponsors
EVASTEM Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who meet all of the following criteria will be eligible 1)Men and women between the ages of 20 and 80 years 2)Patients with ICRS Grade 3 or 4 cartilage damage or deficiency in the knee joint as determined by magnetic resonance imaging (MRI) during the screening phase or by examination within the past 3 months. 3)Patients with a K and L Grade of 2 to 4 based on simple x-ray examination 4)Patients with an area of lesion damage of 2-9 cm2 that is the primary source of clinical symptoms 5)Patients with knee flexion contractures of 10 degrees or less 6)Patients who are eligible for high tibial osteotomy with a lateral knee angle (FTA:Femoro-tibial angle) of 180 to 185 degrees. 7)Patients with pain of 40 mm or more on the 100 mm VAS Scale 8)Patients with a BMI of 35 kg/m2 or less 9)Patients who do not wish to become pregnant during the trial period 10)Patients who have voluntarily decided to participate in the trial and have signed the consent form.
Exclusion criteria
Exclusion criteria: Patients who meet any of the following criteria shall be excluded 1)no remaining lateral cartilage due to progressive osteoarthritis of the knee 2) autoimmune diseases or a history of such diseases 3)an infection or suspected infection requiring parenteral antibiotics 4)serious cardiovascular disease (myocardial infarction, congestive heart failure, uncontrolled hypertension, or other serious cardiac disease) or a history of such disease 5)gout or suspected gout 6)blood clotting abnormalities 7)serious renal function abnormalities 8)serious liver damage 9)serious medical conditions 10)malignancy or suspected malignancy 11)who are pregnant or potentially pregnant 12)who are currently breastfeeding 13)mental disorders or a history of mental disorders 14)who are habitual drinkers and are dependent or suspected of being alcoholic 15)who are nicotine dependent or suspected to be so 16)chronic inflammatory joint diseases 17)who have received immunosuppressive drugs such as cyclosporine A or azathioprine within the past 6 weeks 18)ligament fiber damage of Grade II or greater 19)paralysis due to nerve or muscle disease on the side of the knee joint cartilage damage or defect 20)a history of serious hypersensitivity to bovine-derived or porcine derived ingredients of this product 21)a history of severe hypersensitivity or anaphylactic shock to gentamicin 22)a history of severe hypersensitivity or anaphylactic shock to metal allergy 23)a history of severe hypersensitivity or anaphylaxis to sodium hyaluronate or products containing hyaluronic acid 24)a history of blood transfusion or transplantation 25)who have participated in another clinical trial within the past 3 months 26)who have been at rest for a long period of time within the past 3 months 27)a history of contraindications to MRI or contrast media 28)meniscus locking symptoms 29) Other patients who are determined to be unsuitable by the investigator or sub-investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of improvement in ICRS grade 1 or better at 52 weeks after treatment | — |
Countries
Japan
Contacts
Public ContactMasao Yamamoto
EVASTEM Co., Ltd. President & CEO
Outcome results
None listed