None listed
Conditions
Interventions
Medical Device, Procedure/Surgery : 1. Experimental Group (Microfracture Combined with Cartilage Regeneration Platform)
Microfracture is performed arthroscopically (perforations of 1.2–1.8mm diameter,
Sponsors
ROKIT HEALTHCARE Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) The patient has cartilage damage in the target knee corresponding to ICRS grade 3 or 4. (2) The size of the cartilage defect lesion in the target knee is greater than or equal to 1.5cm² and less than or equal to 10cm². (3) The target knee is clinically determined to require microfracture, or microfracture combined with high tibial osteotomy (HTO). (4) The subject has received a full explanation of the clinical trial and voluntarily provided written informed consent.
Exclusion criteria
Exclusion criteria: (1) Patients with traumatic osteoarthritis or secondary osteoarthritis (Secondary OA) in the target knee. (2) Patients with inflammatory joint disease in the target knee (e.g., rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, reactive arthritis, systemic lupus erythematosus, gout, pseudogout, Behcet's disease, etc.). (3) Patients undergoing immunosuppressive therapy or those with severe systemic disease (e.g., severe cardiovascular disease, long-term users of immunosuppressants, cancer patients undergoing chemotherapy, systemic autoimmune disease, severe hepatic or renal impairment, uncontrolled endocrine disease, etc.). (4) Subjects with evidence of advanced severe osteoarthritis (KL grade 4) in the target knee. (5) Subjects with lower limb malalignment that could affect the surgical plan (e.g., genu varum with a varus angle of 15° or greater, etc.). (6) Patients with a history of bone infection or a diagnosis of malignant tumor in the target knee within 5 years prior to Visit 1, or those with recurrent malignant tumors. (However, in the case of benign tumors, subjects may be enrolled if the investigator determines that it will not affect the progress of the clinical trial during the study period). (7) Subjects with a body mass index (BMI) 35 (kg/?)or greater. (8) Subjects with clinically significant knee instability in the target knee that would not be improved by the surgery applied in this study (e.g., major ligament injury such as a complete or partial tear of the anterior cruciate ligament [ACL], posterior cruciate ligament [PCL], medial collateral ligament [MCL], or lateral collateral ligament [LCL]). (9) Subjects with a history of prior surgery for the purpose of treating cartilage defects in the target knee (excluding simple diagnostic arthroscopy). (10) Subjects with a history of major structural surgery in the target knee (excluding simple diagnostic arthroscopy). (11) Subjects with a history of intra-articular injection of biological or pharmacological agents into the target knee within 3 months prior to Visit 1 (e.g., hyaluronic acid, steroids, platelet-rich plasma [PRP], autologous cell therapy, cytokine inhibitors, etc.). (12) Use of systemic steroids within 1 month prior to Visit 1. (13) Men or women of childbearing potential (or whose partner is of childbearing potential) who do not agree to use one of the following effective methods of contraception during the clinical trial period: -Surgical sterilization of the subject or partner (vasectomy, bilateral oophorectomy and salpingectomy/tubal ligation, hysterectomy) -Intrauterine device (copper IUD, hormone-releasing intrauterine system [IUS]) -Parenteral hormonal contraceptive or spermicide used in combination with a barrier method -Cervical cap or contraceptive diaphragm used in combination with a male condom. (14) Pregnant or lactating women. (15) Subjects who have participated in another clinical trial and received an investigational medical device within 6 months prior to Visit 1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total KOOS (Knee Injury and Osteoarthritis Outcome Score) score | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in total KOOS (Knee Injury and Osteoarthritis Outcome Score) score;MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) score assessed by independent evaluators;Change in 100mm VAS (Visual Analog Scale for pain);Change in IKDC (International Knee Documentation Committee) score | — |
Countries
Korea, Republic of
Contacts
Public ContactJONGBEOM JANG
Seoul National University Bundang Hospital
Outcome results
None listed