Advanced Cartilage Treatment With Injectable-hydrogel Validation of the Effect

Inclusion Criteria:

1. Subject is at least 18 years and maximum 50 years of age at time of surgery;
2. Subject presents with a symptomatic defect in the knee with an NRS pain score of 4 ormore;
3. Subject presents with defects in the knee cartilage with ICRS classification gradesIIIa or IIIb;
4. Subject has a contained lesion of between 0.5 - 2 cm2 in size, and it is localized onthe femoral condyle or trochlea;
5. Subject has an intact (ICRS grade ≤ 1) articulating joint surface (without "kissinglesions");
6. Subject is willing and able to comply with all aspects of the treatment, includingMRI, after-care rehabilitation and evaluation schedule over a 12-month duration; and
7. Subject is willing and able to provide documented Ethics Committee-approved informedconsent prior to initiation of any study procedures.

Exclusion Criteria:

1. Subject has a BMI > 30 kg/m2;
2. Subject has multiple defects to be treated that are interconnected or that have lessthan 0.5 cm of space in between them;
3. Subject underwent index-knee surgery < 3 months prior to study treatment.
4. Subject suffers from any medical condition that would hinder cartilage repair, such asadditional unresolved comorbidities related to the index knee:
5. Untreated anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) deficiency or,
6. Complex ligamentous instability of the knee/ insufficient ligament support,
7. Meniscus lesions, total or partial (more than 1/2 of total volume) resectedmeniscus,
8. Limited joint mobility,
9. Varus/valgus joint malalignment of more than 3 degrees,
10. Subject has a trochlear cartilage defect that is associated with (suspected)patella maltracking without surgical correction,
11. Subject underwent previous (failed) cartilage repair procedure(s), such asmicrofracture (MF), Osteochondral Autograft Transplantation (OATS) or AutologousChondrocyte Implantation (ACI) with or without use of a scaffold (matrix) in theindex knee. Comorbidities that are resolved during the same surgical procedure as theinvestigational device treatment, do not qualify for this exclusion criterion.
12. Subject has (history of) generalized osteoarthritis, defined as Kellgren-Lawrencegrade >1 as determined from recent (<6 months at time of enrollment) X-ray;
13. Subject suffers from inflammatory joint diseases (e.g. rheumatoid arthritis, Bechterewdisease, chondromatosis);
14. Subjects suffers from autoimmune disease, vascular or neurological disease;
15. Subject suffers from an active or recent local or systematic infection, or has ahistory of knee infections;
16. Subject has an active malignant tumor at the time of treatment;
17. Subject has hypersensitivity or allergy to the constituents of the product.
18. Pregnant or lactating women at the time of enrollment or women who are planning tobecome pregnant during the duration of the study.