Prospective Multicenter Post-market Study of the Zimmer NexGen LPS-Flex Porous Femoral Components
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Survivorship
研究概览
简要总结
This is a prospective multicenter study of the LPS-Flex Porous Femoral Components when used in primary total knee arthroplasty. The purpose of the study is to obtain short-, mid-, and long-term clinical outcomes and implant survivorship data for the NexGen LPS-Flex Porous Femoral components.
详细描述
Survival and outcome data on the NexGen LPS-Flex Porous Femoral Components will be done by an analysis of standard scoring system, radiographs and adverse event records. Survivorship will be evaluated by monitoring the frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated adverse device effects. Outcomes will be measured by comparing the overall pain and function performances (based on the Knee Society Scoring System), survivorship, subject quality of life and radiographic parameters of study subjects receiving the LPS-Flex Porous Femoral Components.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient 18-75 years of age, inclusive;
- •Patient qualifies for a total knee arthroplasty based on physical exam and medical history including at least one of the following: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle;
- •Post-Traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy;
- •Moderate valgus, varus, or flexion deformities;
- •Patient has undergone a study related informed consent process;
- •Patient is willing and able to provide written consent;
- •Patient is willing and able to cooperate in the required post-operative therapy;
- •Patient is willing and able to complete scheduled follow-up evaluations.
排除标准
- •Patient has previous history of infection in the affected joint and/or a local or systemic infection that could affect the prosthetic joint;
- •Insufficient bone stock on femoral or tibial surfaces;
- •Skeletal immaturity;
- •Neuropathic arthropathy;
- •Osteoporosis or any loss of musculature or neuromuscular disease that compromises the affected limb;
- •Stable, painless arthrodesis in a satisfactory functional position;
- •Severe instability secondary to the absence of collateral ligament integrity;
- •Patient has rheumatoid arthritis and an ulcer of the skin or a history of recurrent breakdown of the skin because of their risk of postoperative infection is greater;
- •Patient has a known sensitivity or allergy to one or more of the implanted materials;
- •Patient is pregnant or considered a member of a protected population (e.g., prisoner, mental incompetence, unable to understand what clinical trial participation entails, etc.)
结局指标
主要结局
Survivorship
时间窗: 10 Years
Based on frequency of adverse events, serious adverse events, adverse device effects, serious adverse device effects and unanticipated adverse device effects or removal of the device summarized using a Kaplan-Meier method and presented with rates (as percentages) and confidence intervals.
次要结局
- Pain and Functional Performance(10 years)