Multi-centre, Open Label, Prospective, Consecutive Series Registry Database of BioPoly RS Partial Resurfacing Knee Implant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- BioPoly LLC
- 入组人数
- 38
- 试验地点
- 5
- 主要终点
- Knee Injury and Osteoarthritis Outcome Score (KOOS)
研究概览
简要总结
Information will be collected on the pre-op and post-op clinical status of patients with focal cartilage defects of the femoral condyles treated with the BioPoly RS Partial Resurfacing Knee Implant, a permanent orthopaedic implant. The overall aim of the study is to increase the knowledge of patient outcomes such as pain, knee function, level of activity, and overall quality of life after treatment with the device.
详细描述
Information will be collected on the pre-op and post-op clinical status of patients with focal cartilage defects of the femoral condyles treated with the BioPoly RS Partial Resurfacing Knee Implant, a permanent orthopaedic implant. The overall aim of the study is to increase the knowledge of patient outcomes such as pain, knee function, level of activity, and overall quality of life after treatment with the device. Patients will be followed for 5 years after surgery.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cartilage lesion located in weight bearing region of medial or lateral femoral condyles that have failed prior therapy (conservative or surgical)
- •Lesion classified as ICRS Grade 2, 3, or 4
排除标准
- •Body mass index (BMI) of 30 or more
- •Osteoarthritis or rheumatoid arthritis
- •Uncorrected mal-alignment, ligamentous instability, or meniscal tear
- •Total meniscectomy
- •Kissing lesion on tibia
研究组 & 干预措施
BioPoly RS Implant
BioPoly RS Implant
干预措施: BioPoly RS Partial Resurfacing Knee Implant (Device)
结局指标
主要结局
Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: 2 years
Knee function assessment
Knee Injury and Osteoarthritis Outcome Score (KOOS)
时间窗: 6 months
Knee function assessment
次要结局
- Tegner Activity(Through 5 years)
- Knee Injury and Osteoarthritis Outcome Score (KOOS)(Through 5 years)
- VAS Pain(Through 5 years)
- SF-36(Through 5 years)