None listed
Conditions
Interventions
Medical Device : The basic purpose of the partial menisectomy, selected as a control group, is to remove unstable meniscus that has been damaged and transformed into abnormal tissues and preserves as
Sponsors
Cellumed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients who need 20% or more resection of medial or lateral cartilage 2. Patients who maintain the tension of the marginal edge of the meniscus 3. Acute and chronic patients (including 1 cartilage discectomy or suture) 4. Patients aged 16-60 5. Patients with more than 1 mm cartilage plate rim and anterior and olfactory angles 6. Patients with normal lower limb alignment 7. Patients with no ligament damage to the affected knee joint (including those without ligament instability among patients 2 years after ligament surgery) 8. If the cartilage lesion is not severe
Exclusion criteria
Exclusion criteria: 1. Patients with all cartilage plates removed 2. Patients with subtotal cartilage resection and loss of rim of the cartilage plate over 1 mm and continuity of the anterior and olfactory angles. 3. In case of severe cartilage lesion (Outerbridge Grade IV) 4. Patients with ligament instability in the knee area to be operated on 5. Patients with rheumatoid arthritis, inflammatory or purulent arthritis, and autoimmune diseases 6. Patients with evidence of osteonecrosis in the knee to be operated on 7. Kellgren-Lawrence grade IV arthritis patient 8. Patients with uncorrected deformity or abnormal lower limb alignment in the knee to be operated on 9. Patients with a history of anaphylaxis due to immune rejection of the implant 10. Patients systemically administered adrenocorticosteroids, anti-tumor drugs, immunostimulants or immunosuppressants within 30 days of surgery 11. Patients with systemic or local infectious diseases 12. Pregnant women, nursing women, or those who disagree with contraception* during this clinical trial *Contraception: oral contraceptives (limited to those who have been continuously taking at least 3 months before application of clinical trial medical devices), hormonal contraceptives, implantation of intrauterine devices or intrauterine systems, double blocking method (male: spermicide and condom , Female: vaginal diaphragm for contraception, vaginal sponge or neck cap), sterilization procedure (vasectomy, tubal ligation, etc.) 13. Patients with neurological disorders unable to participate in rehabilitation programs after surgery 14. Patients with allergies to collagen of animal origin 15. Patients allergic to sodium chondroitin sulfate, an animal-derived substance
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Meniscus Defect Filling rate (%) MRI evaluation | — |
Secondary
| Measure | Time frame |
|---|---|
| Change amount of Genovese grade of Meniscus Defect Filling ;Change amount of WORMS (Whole-Organ Magnetic Resonance Imaging Score) ;Change amount of X-ray (joint space narrowing) K-L grade ;The amount of change in pain evaluated by the subject's 100 mm VAS (Visual Analog Scale, Visual Pain Assessment Scale) ;Changes in quality of life evaluated by IKDC (International Knee Documentation Committee, Knee Functionality and Activity Assessment Index) ;Change in quality of life evaluated by KOOS (Knee Injury and Osteoarthritis Outcome Score, Functionality, Pain, Quality of Life Evaluation Index) | — |
Countries
Korea, Republic of
Contacts
Public ContactCheol Hee Park
KyungHee University Medical Center
Outcome results
None listed