Advanced Cartilage Treatment With Injectable-hydrogel Validation of the Effect

Launched by HY2CARE BV · Dec 23, 2021

Keywords

ClinConnect Summary

This is a multi-center, pivotal, non-randomized, prospective, open-label clinical investigation.

Safety oversight throughout will be provided by an independent Data Monitoring Committee (DMC) comprised of a clinical expert (knee surgeon), medical monitor and a senior statistician.

The clinical investigation will be split into two cohorts:

Safety cohort: The safety cohort is intended to determine the primary safety of the investigational device. In this cohort, 10 subjects will be treated at preferably 1 site. The safety cohort will receive the investigational device intraoperatively.

Fo...

Gender

ALL

Eligibility criteria

• 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 or more;
• • 3. Subject presents with defects in the knee cartilage with ICRS classification grades IIIa or IIIb;
• • 4. Subject has a contained lesion of between 0.5 - 2 cm2 in size, and it is localized on the femoral condyle or trochlea;
• • 5. Subject has an intact (ICRS grade ≤ 1) articulating joint surface (without "kissing lesions");
• • 6. Subject is willing and able to comply with all aspects of the treatment, including MRI, after-care rehabilitation and evaluation schedule over a 12-month duration; and
• • 7. Subject is willing and able to provide documented Ethics Committee-approved informed consent 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 less than 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 as additional unresolved comorbidities related to the index knee:
• • 1. Untreated anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) deficiency or,
• • 2. Complex ligamentous instability of the knee/ insufficient ligament support,
• • 3. Meniscus lesions, total or partial (more than 1/2 of total volume) resected meniscus,
• • 4. Limited joint mobility,
• • 5. Varus/valgus joint malalignment of more than 3 degrees,
• • 6. Subject has a trochlear cartilage defect that is associated with (suspected) patella maltracking without surgical correction,
• • 7. Subject underwent previous (failed) cartilage repair procedure(s), such as microfracture (MF), Osteochondral Autograft Transplantation (OATS) or Autologous Chondrocyte Implantation (ACI) with or without use of a scaffold (matrix) in the index knee.
• • Comorbidities that are resolved during the same surgical procedure as the investigational device treatment, do not qualify for this exclusion criterion.
• • 5. Subject has (history of) generalized osteoarthritis, defined as Kellgren-Lawrence grade \>1 as determined from recent (\<6 months at time of enrollment) X-ray;
• • 6. Subject suffers from inflammatory joint diseases (e.g. rheumatoid arthritis, Bechterew disease, chondromatosis);
• • 7. Subjects suffers from autoimmune disease, vascular or neurological disease;
• • 8. Subject suffers from an active or recent local or systematic infection, or has a history of knee infections;
• • 9. Subject has an active malignant tumor at the time of treatment;
• • 10. Subject has hypersensitivity or allergy to the constituents of the product.
• • 11. Pregnant or lactating women at the time of enrollment or women who are planning to become pregnant during the duration of the study.