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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Performance
研究概览
简要总结
Multicentre, pivotal, non-randomized, prospective, open-label clinical investigation involving a new hydrogel, Hy2Care Injectable hydrogel, developed by Hy2Care B.V., Enschede, The Netherlands (hereafter referred to as "Hy2Care") to treat cartilage defects (< 2 cm2) in the human knee. The product aims at functional repair of cartilage defects in the knee and regeneration of cartilage.
The objective of this clinical investigation is to demonstrate the clinical safety and performance of the Hy2Care Injectable hydrogel. Data from this clinical investigation will be used to support a CE marking application for the Hy2Care Injectable hydrogel.
Sites will be selected based on a documented site qualification procedure. The Principal Investigator at each site will be selected based on confirmed expertise in the orthopaedic field. Each site will have a designated Principal Investigator and one or more study coordinators collectively responsible for the study data collection, inclusive of screening, enrolment, evaluation and documentation, in accordance with the International Organization for Standardization (ISO) 14155 guidelines for Good Clinical Practice. Per site, one physician will be assigned as Principal Investigator. Other physicians will be referred to as 'sub-investigators'.
详细描述
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.
Following implantation of the investigational device in the initial safety cohort, the DMC will continuously monitor all emerging safety issues against the defined stopping rules of the clinical investigation. Any treatment-emergent severe adverse events or other safety concerns during the safety phase of the clinical investigation will immediately be referred, on a case by case basis, to the DMC for review against the stopping rules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Performance
时间窗: 12 months follow up
Change from baseline in the composite (average of the 5 subscales) Knee Injury and OsteoArthritis Outcome Score (KOOS) at 12 months post-surgery. Performance: • Change from baseline in the composite (average of the 5 subscales) Knee Injury and OsteoArthritis Outcome Score (KOOS), at 12 months post-surgery. Hypothesis: Average change from baseline in the composite Knee Injury and OsteoArthritis Outcome Score (KOOS) at 12 months post-surgery with Hy2Care Injectable hydrogel is greater than a minimal clinically important change (MIC) of 10.
次要结局
- Cartilage Regeneration via Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART)(12 months)