A multi-center, pivotal, non-randomized, prospective, open-label study to evaluate the safety and performance of the Hy2Care Injectable Hydrogel for the repair of cartilage defects in the knee.
- Conditions
- Cartilage defectcartilage lesion1004323710005944
- Registration Number
- NL-OMON50832
- Lead Sponsor
- Hy2Care B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 46
1. Subject is at least 18 years and maximum 50 years of age at time of consent;
2. Subject presents with a symptomatic defect in the knee with an NRS pain
score of 4 or more;
3. Subject presents with defect(s) in the knee cartilage with ICRS
classification grades IIIa or IIIb;
4. Subject has a contained lesion(s) of between 0.5 - 2 cm2 in size, and it is
localized on the femoral condyle or trochlea; if there are multiple defects,
the sum of all sizes should not be more than 2 cm2;;
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.
1. Subject has a BMI > 30 kg/m2;
2. Subject underwent index-knee surgery < 3 months prior to study treatment.
3. Subject suffers from any medical condition that would hinder cartilage
repair, such as additional unresolved comorbidities related to the index knee:
a. Untreated anterior cruciate ligament (ACL) and/or posterior cruciate
ligament (PCL) deficiency or,
b. Complex ligamentous instability of the knee/ insufficient ligament support,
c. Meniscus lesions, total or partial (more than 1/2 of total volume) resected
meniscus,
d. Limited joint mobility (flexion less than 110 degrees),
e. Untreated varus/valgus joint malalignment of more than 5 degrees,
f. Subject has a trochlear cartilage defect that is associated with (suspected)
patella maltracking without surgical correction;
g. 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.
4. Subject has (history of) generalized osteoarthritis, defined as
Kellgren-Lawrence grade >1 as determined from recent (<6 months at time of
enrollment) X-ray;
5. Subject suffers from inflammatory joint diseases (e.g. rheumatoid arthritis,
Bechterew disease, chondromatosis);
6. Subjects suffers from autoimmune disease, vascular or neurological disease;
7. Subject suffers from an active or recent local or systematic infection, or
has a history of knee infections;
8. Subject has an active malignant tumor at the time of treatment;
9. Subject has hypersensitivity or allergy to the constituents of the product.
10. Pregnant or lactating women at the time of enrollment or women
who are planning to become pregnant during the duration of the
study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Safety:<br /><br>• Incidence, nature and severity of procedure and/or device related adverse<br /><br>events up to 3 months post-surgery.<br /><br><br /><br>Performance:<br /><br>• Change from baseline in the composite (average of the 5 subscales) KOOS at 12<br /><br>months post-surgery.</p><br>
- Secondary Outcome Measures
Name Time Method