A Prospective, Multi-Center, Non-Randomized, Safety and Efficacy Clinical Study of the LEGION™ Primary Knee System for Primary Total Knee Replacement in Subject With Degenerative Knee Disease
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 128
- 试验地点
- 10
- 主要终点
- Implant Survivorship Percentage
研究概览
简要总结
This study will look at the health results of using the LEGION™ Primary Knee System over a period of ten (10) years. This type of surgery uses an artificial knee made of plastic and metal. This study will enter subjects who suffer from a variety of conditions that have caused at least one of their knees to become nonfunctional. You are being asked to participate in the study because you have significant problems with your knee(s) and your study surgeon has determined that your knee(s) must be surgically replaced to improve your condition. If you decided to participate in this study, you will be one of approximately one hundred thirty-eight (138) subjects in the study.
详细描述
This is a prospective, consecutive series, multi-center clinical study of the LEGION™ Total Knee System. The study design was selected to assess the safety and effectiveness profile of the LEGION™ Total Knee System in subjects with degenerative knee disease requiring primary total knee replacement.
Subjects meeting the entrance criteria specified in this protocol will be approached to participate in the study and enrolled sequentially. Any consenting subjects meeting the inclusion criteria are not to be excluded unless they do not consent to participate. A nonrandomized, consecutive series of up to 138 subjects will be enrolled at a maximum of 8 research sites, with an expectation of 18 subjects (up to a maximum of 28 subjects) to be enrolled at each site. When 138 subjects are enrolled from all sites, enrollment will be stopped, regardless of the number contributed from each site. Sites will be selected for participation in the study at the discretion of Smith & Nephew.
Follow-up clinical assessments will be at Operative/Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years. Each subject will receive a standard radiographic evaluation at discharge that will be used for baseline analysis. Additional radiographic analysis will be performed at Operative/Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years and 10 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •Subjects must meet all of the inclusion criteria:
- •Subject is a candidate for the LEGION™ Primary Knee System according to the instructions for use
- •Subject is of legal age and skeletally mature
- •Subject is willing to sign and date an ethics-approved consent form and participate in the study
- •Subject is willing to be available for ten-year follow-up postoperatively.
排除标准
- •Subjects must not meet any of the exclusion criteria:
- •Subject with immunosuppressive disorders
- •Subject has grossly insufficient femoral or tibial bone stock
- •Subject has an active localized or systemic infection
- •Subject is pregnant
- •Subject psychological or neurological conditions that would impair the subject's ability or willingness to restrict activities or follow medical advice during the course of this study
- •Subject is a prisoner.
结局指标
主要结局
Implant Survivorship Percentage
时间窗: Postoperatively through 120 months
Kaplan-Meier (KM) implant survivorship where survivorship defined as percentage of knees where no revision was required for any reason through 120 months
次要结局
- Knee Society Score (KSS) - Performance(Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months)
- Knee Society Score (KSS) - Function(Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months)
- Knee Osteoarthritis Outcome Score (KOOS) - Pain(Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months)
- Knee Osteoarthritis Outcome Score (KOOS) - Symptom(Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months)
- Knee Osteoarthritis Outcome Score (KOOS) - Function in Daily Living (ADL)(Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months)
- Knee Osteoarthritis Outcome Score (KOOS) - Sports and Recreational Activities(Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months)
- Knee Osteoarthritis Outcome Score (KOOS) - Quality of Life (QoL)(Preoperative, 3 months, 12 months, 24 months, 36 months, 60 months, 84 months, 120 months)
- Radiographic Evaluation - Radiolucent Lines(Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
- Radiographic Evaluation - Observed Periosteal Hypertrophy, Implant Loosening, Osteolysis or Subsidence(Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)
- Radiographic Evaluation - Observed Patellar Problem(Discharge, 3 months, 1 year, 2 years, 3 years, 5 years, 7 years, 10 years)