Prospective, Single-arm, Single-center Exploratory Study on Safety of PEEK Knee Prosthesis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Safety measures at 12 months after surgery
研究概览
简要总结
In this study, 10 subjects will be underwent total knee arthroplasty with PEEK knee prosthesis and be followed up 3, 6, and 12 months after surgery. The safety of the knee prosthesis for total knee arthroplasty will be investigated based on X-ray, magnetic resonance imaging, thin-section CT, hematological indexes, knee function, complications and the occurrence of serious adverse events at the 12-month follow-up.
详细描述
According to the involved person's biomedical research ethics review method "(national health and family planning commission (11)) and the medical and health institutions to carry out the researchers launched a clinical research management method" (draft) on request, for national key development plan required for research and development production of PEEK knee prosthesis for clinical trials. In this study, 10 subjects will be underwent total knee arthroplasty with PEEK knee prosthesis and be followed up 3, 6, and 12 months after surgery. The safety of the knee prosthesis for total knee arthroplasty will be investigated based on X-ray, magnetic resonance imaging, thin-section CT, hematological indexes, knee function, complications and the occurrence of serious adverse events at the 12-month follow-up.
Since this study is an exploratory study, all subjects will be retrospectively studied one year after the end of the study.
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
- 55 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects aged 55 years of age or older and less than 74 years of age, younger subjects should have urgent need for surgery.
- •Subjects skeletal maturity.
- •Subjects appropriate for total knee replacement, such as noninflammatory degenerative joint diseases (such as osteoarthritis, traumatic arthritis, or ischemic necrosis); Inflammatory degenerative joint diseases (including rheumatoid arthritis); Correction of functional deformity.
- •The diseased side knee appropriate for primary total knee arthroplasty .
- •Subjects or guardian is willing and able to sign the informed consent form .
排除标准
- •Subjects with knee instability or abnormal gait caused by neuromuscular insufficiency.
- •Subjects with bilateral knee joint disease who are expected to require replacement of both knees during the course of the study (i.e., within the next 12 months) .
- •Alcoholics, drug addicts and drug abusers.
- •Subjects with severe diabetes (fasting blood glucose > 10mmol/L)
- •Body Mass Index, BMI>
- •Female subjects who are pregnant or lactating.
- •Subjects have disease limited their participation in the investigation or have an existing condition that would compromise their participation and follow-up in this clinical investigation.
- •In the month before inclusion, subjects who participated in clinical studies of other drugs, biological agents or medical devices and failed to meet the main research endpoints.
- •Other conditions, in the opinion of the Investigator, are inappropriate for participation in this clinical investigation.
结局指标
主要结局
Safety measures at 12 months after surgery
时间窗: 12 months
The expected incidence of device-related complications within 12 months after surgery is 0.
次要结局
- X-ray examination(At 3 and 12 months postoperatively)
- MRI(3 and 12 months after surgery)
- Excellent and good rates of the KSS knee scoring system at 3,6, 12 months postoperatively(3,6, 12 months after surgery)
- CT(one week and 12 months after surgery)
- Hematological examination indexes 3 and 12 months after surgery(3 and 12 months after surgery)
研究者
You Wang
Prospective, Single-arm, Single-center Exploratory Study on Safety of PEEK Knee Prosthesis
RenJi Hospital