Open Label, Prospective, Consecutive Series Registry Database of BioPoly® RS Partial Resurfacing Patella Implant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- BioPoly LLC
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- KOOS Subscores
研究概览
简要总结
The data registry will increase the knowledge of outcomes for treatment of focal cartilage defects of the patella treated with the BioPoly RS Patella Implant and will allow monitoring of the clinical safety and performance of the device and surgical implantation kit
详细描述
The data registry will increase the knowledge of outcomes for treatment of focal cartilage defects of the patella treated with the BioPoly RS Patella Implant This study will also allow monitoring of the clinical safety and performance of the device and surgical implantation kit
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 21 years and older
- •Cartilage lesion(s) located in the facets of the patella that have failed prior therapy (conservative or surgical)
- •Symptomatic lesions classified as ICRS grade 2, 3, or 4
- •Lesion size may not exceed 3.1 cm2 and must be circumscribed by a 15 mm or 20 mm circle of normal or nearly normal (ICRS Grade 0 or 1) cartilage, with an overall depth less than 4 mm from the articulating surface
- •Subchondral bone quality sufficient to support the implant
- •Understanding and willingness to comply with the post-operative rehabilitation instructions and follow-up visits.
排除标准
- •Body mass index (BMI) ≥ 35
- •Generalized degenerative or autoimmune arthritis
- •Uncorrected chronic malalignment of the patella (may be corrected at the same time as the implantation of the BioPoly device).
- •Uncorrected ligamentous instability (may be corrected at the same time as the implantation of the BioPoly device).
- •Kissing lesion on femur
- •More than one implant required to accommodate lesion
- •Allergy to ultra-high molecular weight polyethylene (UHMWPE), or hyaluronan/ hyaluronic acid (HA)
- •Use with opposing articulating femoral components
- •Any concomitant painful or disabling disease of the spine, hips, or lower limbs that would interfere with evaluation of the afflicted knee
- •Pregnant, prisoner, vulnerable population, or unable to provide informed consent.
结局指标
主要结局
KOOS Subscores
时间窗: 2 year post-op
KOOS
Medical Outcomes Study (SF-36) for generic "quality of life"
时间窗: 2 years post-op
SF-36
Activity using Tegner Score
时间窗: 2 years post-op
Tegner
Kujala Anterior Knee Pain Scale
时间窗: 2 year post-op
Kujala
Pain using VAS Pain
时间窗: 2 years post-op
VAS Pain
次要结局
- Radiographic Assessment(Annually through 5 years post-op)