A Retrospectively Enrolled and Prospectively Followed, Post-market, Multi-center Evaluation of the Clinical Outcomes of the Triathlon All-Polyethylene Tibia
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 204
- 试验地点
- 6
- 主要终点
- Knee Society Score (KSS) Function
研究概览
简要总结
The purpose of this study is to evaluate the clinical functional results of the Triathlon All-Polyethylene Tibia Knee Device.
详细描述
This study is a retrospectively enrolled, prospective evaluation of the Triathlon All-Polyethylene Tibia (APT) for patients who meet the eligibility criteria. The enrolled cases will be followed for outcomes measured to 10 years. A modular, Triathlon metal-backed tibia (MBT) and polyethylene insert construct will be used as a historical control.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusions:
- •Patient underwent primary TKA and is currently implanted with the Triathlon All-Polyethylene Tibia as well as compatible Stryker femoral and patellar components with no pending revision or removal.
- •Patient has signed an IRB-approved, study specific Informed Patient Consent Form.
- •Patient is a male or non-pregnant female and is 18 years of age or older at the time of study device implantation.
- •Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations.
- •Exclusions:
- •Patient had an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
- •Patient had distant foci of infection which could have caused hematogenous spread to the implant site at time of study device implantation.
- •Patient was skeletally immature at time of study device implantation.
- •Patient has a mental or neuromuscular disorder which would create an unacceptable risk of prosthesis instability, prosthesis fixation failure, or complications in postoperative care.
- •Patient's bone stock was compromised by disease, infection, or prior implantation which cannot provide adequate support and/or fixation to the prosthesis.
- •Patient had severe instability of the knee joint secondary to the absence of collateral ligament integrity and function.
- •Patient was immunologically suppressed or receiving steroids in excess of normal physiological requirements at the time of surgery (e.g. > 30 days duration of treatment).
- •Patient is a prisoner.
排除标准
- 未提供
研究组 & 干预措施
Triathlon All-Polyethylene Tibia Knee
All subjects enrolled will have received the Triathlon All-Polyethylene Tibia Knee device.
干预措施: Triathlon All-Polyethylene Tibia Knee (Device)
结局指标
主要结局
Knee Society Score (KSS) Function
时间窗: 10-years postoperative
The Knee Society Clinical Rating System is comprised of two distinct sub-scores: one for pain, range of motion (ROM) and joint stability, and one for functional parameters. Sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome postoperative.
次要结局
- Kaplan-Meier Survival Analysis(10-years postoperative)