An Open Non-comparative Clinical Investigation of a Novel Decellularised Porcine Xenograft (dCELL® Meniscus) for Partial Replacement of the Meniscus
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 发起方
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Pain relief as assessed by Visual Analog Scale (VAS)
研究概览
简要总结
The safety and performance of dCELL® Meniscus will be evaluated in 60 patients after partial replacement of the native medial or lateral meniscus with the investigational product.
详细描述
The dCELL® Meniscus is a novel decellularised porcine xenograft which is processed using a patented variation of Tissue Regenix's platform dCELL® technology to render it biocompatible and free from cellular material, leaving behind an acellular biological scaffold that is safe for human implantation whilst preserving the biomechanical properties. It is indicated as a biological implant to replace parts of the native meniscus in the knee for patients who present with chronic pain following failed previous meniscus repair or partial meniscectomy.
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
- •Patients diagnosed with chronic pain following failed previous meniscus repair or partial meniscectomy
- •Must be a stable, well aligned knee with ligament laxity of Grade II or less
- •Osteoarthritis <grade 3 on the Kellgren Lawrence scale
- •Patients who have given written informed consent; and are willing and able to comply with entire study procedures including rehabilitation protocol
排除标准
- •Body Mass Index (BMI) greater than 35 kg/m2
- •Treatment with any investigational drug or device within two months prior to screening
- •Patients presenting with abnormal degenerative osteoarthritis of the joint
- •Patients with a current ligament injury requiring immediate surgery or have had ligament surgery in the previous three months
- •Patients using anticoagulants
- •Patients on current immuno-suppressive or radiation therapy or having received such therapies within six months of screening
- •Patients with diabetes or cardiovascular disease which precludes elective surgery
- •Patients with documented renal disease or metabolic bone disease
研究组 & 干预措施
dCELL® Meniscus
干预措施: dCELL® Meniscus (Device)
结局指标
主要结局
Pain relief as assessed by Visual Analog Scale (VAS)
时间窗: 24 months
Change in VAS Pain score from baseline
次要结局
- Knee functional improvement as assessed by patient questionnaires(24 months)