A Prospective, Non-comparative Clinical Investigation of a Novel Decellularised Porcine Xenograft (dCELL® ACL Scaffold) for Reconstruction of the Anterior Cruciate Ligament
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 16
- 主要终点
- Arthrometric measurement of knee joint laxity
研究概览
简要总结
The safety and performance of dCELL® ACL Scaffold will be evaluated in 40 patients who have been implanted with the investigational product following a ruptured anterior cruciate ligament (ACL) of the knee.
详细描述
The dCELL® ACL Scaffold is a novel device manufactured from porcine tissue using a patented variation of Tissue Regenix's platform technology to render the tissue biocompatible and free from cellular material, providing a biological scaffold that is safe for human implantation whilst preserving the biomechanical properties.
The device is used to reconstruct traumatic ACL tears to help restore normal knee function and therefore prevent further wear of the cartilage and future damage.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with partial or complete tear of the ACL and require reconstruction of the ACL.
- •Medial Collateral Ligament (MCL) injury grade 2 or less.
- •Osteoarthritis grade 2 or less 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/m
- •Treatment with any investigational drug or device within two months prior to screening.
- •Patients presenting with abnormal degenerative osteoarthritis of the joint.
- •Previous ACL reconstruction on the target knee.
- •Current ACL injury on contralateral knee.
- •Patients using anticoagulants within 2 weeks prior to surgery.
- •Patients on current immuno-suppressive or radiation therapy within six months of screening.
- •Patients with diabetes or cardiovascular disease which precludes elective surgery.
- •Patients with documented renal disease or metabolic bone disease.
结局指标
主要结局
Arthrometric measurement of knee joint laxity
时间窗: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Comparison of the magnitude of side-to-side differences in mm between the treated knee and the opposite normal knee using an arthrometric ligament testing device
Lachman Test
时间窗: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Clinical assessment of knee stability
Number of Participants With Treatment-Related Adverse Events
时间窗: Surgery, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
The frequency and seriousness of any adverse events or adverse device effects will be assessed
Pivot Shift Test
时间窗: Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Clinical assessment of knee stability
次要结局
- Evidence of integration of the investigational product by MRI(Baseline, 3 months, 6 months, 12 months, 24 months)
- Outcome measure questionnaire of knee functional improvement in terms of symptoms, sport activities and ability to function(Baseline, 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months)