NL-OMON50832招募中不适用
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. - ACTIVE
Hy2Care B.V.0 个研究点目标入组 46 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 46
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
入选标准
- •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.
排除标准
- •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
- •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
研究者
相似试验
已完成
2 期
A Prospective, Multi-Center, Non-randomized, Single arm, Open label, Pivotal Study to Evaluate the Safety and Effectiveness of the NovaCross* Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions.PCI CTOstenosis1001108210003216NL-OMON41722itiloop Ltd.50
已完成
不适用
A Prospective, Multi-Center, Non-Randomized, Single-Arm Study of the BARD® LIFESTREAM™ Balloon Expandable Vascular Covered Stent in the Treatment of Iliac Artery Occlusive Disease (BOLSTER)I70.2Atherosclerosis of arteries of extremitiesDRKS00006828Bard Peripheral Vascular, Inc.154
招募中
不适用
Impact of incorporating a polygenic risk score into cardiovascular disease examinations on the identification of subclinical coronary artery disease (CAD)Cardiovascular - Coronary heart diseaseCardiovascular diseaseACTRN12622000436774The University of Sydney1,000
终止
不适用
Research study of a new miniaturized (reduced size) left-ventricular assist device called Miniaturized Ventricular Assist Device(MVAD 'Registered Trademark' System), which is being developed for the treatment of advanced heart failure.Advanced heart failureCardiovascular - Other cardiovascular diseasesACTRN12615001036505HeartWare Inc.11
已完成
不适用
Prospective, multicenter, non-randomized, single-arm observational study to evaluate safety and effectiveness of iCover covered stent for the treatment of the aorto-iliac Occlusive DiseaseAorto-Iliacal ArtheropathyDRKS00028124IVascular240