Status:
UNKNOWN
Advanced Cartilage Treatment With Injectable-hydrogel Validation of the Effect
Lead Sponsor:
Hy2Care BV
Collaborating Sponsors:
Avania
UMC Utrecht
Conditions:
Cartilage Damage
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
Multicentre, pivotal, non-randomized, prospective, open-label clinical investigation involving a new hydrogel, Hy2Care Injectable hydrogel, developed by Hy2Care B.V., Enschede, The Netherlands (hereaf...
Detailed Description
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) compris...
Eligibility Criteria
Inclusion
- Subject is at least 18 years and maximum 50 years of age at time of surgery;
- Subject presents with a symptomatic defect in the knee with an NRS pain score of 4 or more;
- Subject presents with defects in the knee cartilage with ICRS classification grades IIIa or IIIb;
- Subject has a contained lesion of between 0.5 - 2 cm2 in size, and it is localized on the femoral condyle or trochlea;
- Subject has an intact (ICRS grade ≤ 1) articulating joint surface (without "kissing lesions");
- 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
- Subject is willing and able to provide documented Ethics Committee-approved informed consent prior to initiation of any study procedures.
Exclusion
- Subject has a BMI \> 30 kg/m2;
- Subject has multiple defects to be treated that are interconnected or that have less than 0.5 cm of space in between them;
- Subject underwent index-knee surgery \< 3 months prior to study treatment.
- Subject suffers from any medical condition that would hinder cartilage repair, such as additional unresolved comorbidities related to the index knee:
- Untreated anterior cruciate ligament (ACL) and/or posterior cruciate ligament (PCL) deficiency or,
- Complex ligamentous instability of the knee/ insufficient ligament support,
- Meniscus lesions, total or partial (more than 1/2 of total volume) resected meniscus,
- Limited joint mobility,
- Varus/valgus joint malalignment of more than 3 degrees,
- Subject has a trochlear cartilage defect that is associated with (suspected) patella maltracking without surgical correction,
- 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.
- Subject has (history of) generalized osteoarthritis, defined as Kellgren-Lawrence grade \>1 as determined from recent (\<6 months at time of enrollment) X-ray;
- Subject suffers from inflammatory joint diseases (e.g. rheumatoid arthritis, Bechterew disease, chondromatosis);
- Subjects suffers from autoimmune disease, vascular or neurological disease;
- Subject suffers from an active or recent local or systematic infection, or has a history of knee infections;
- Subject has an active malignant tumor at the time of treatment;
- Subject has hypersensitivity or allergy to the constituents of the product.
- Pregnant or lactating women at the time of enrollment or women who are planning to become pregnant during the duration of the study.
Key Trial Info
Start Date :
February 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2024
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05186935
Start Date
February 28 2022
End Date
October 31 2024
Last Update
February 22 2022
Active Locations (1)
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1
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX