A Prospective, Multi-center Clinical Study Evaluating the LEGION™ Hinge Knee System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 47
- 试验地点
- 7
- 主要终点
- Original Knee Society Clinical Score© (KSCS)
研究概览
简要总结
The purpose of the current investigation is to assess the safety and efficacy of a new hinged revision knee device. This device is designed to provide efficient, reproducible reconstructions with optimal limb and implant alignment, durable implant fixation, and functional outcomes that increasingly approach those of primary Total Knee Arthroplasty (TKA).
详细描述
The objective of this study is to demonstrate statistically significant improvements in the original Knee Society Clinical Score (KSCS) from baseline to 1 and 2 years in subjects using the LEGION™ Hinge Knee System. The focus of the 1 and 2 year analyses will be on safety and efficacy. The 5 year analysis will focus on survivorship and safety.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has gross knee instability resulting from loss of collateral ligament function, gross bone loss, comminuted fractures of the proximal tibia or distal femur, rheumatoid arthritis, post-traumatic arthritis, osteoarthritis, degenerative arthritis, failed osteotomies, unicompartmental replacement or total knee replacement, or absent or incompetent posterior cruciate ligament and one or both of the collateral ligaments
- •Subject has a failed primary or revision knee replacement
- •Subject is 18-80 years of age
- •Subject is skeletally mature in Investigator's judgment i.e., subject is not actively growing or does not have immature bones for any reason
- •Subject has met an acceptable preoperative medical clearance and is free of or treated for cardiac, pulmonary, hematological, infection or other conditions that would pose excessive operative risk
- •Subject is willing to sign and date an IRB/EC-approved consent form
- •Subject plans to be available through the five (5) year postoperative follow-up
- •If of child bearing potential, Subject reports she is not pregnant nor plans to become pregnant during the study
- •Subject agrees to follow the study protocol
排除标准
- •Subject is receiving the study device as a primary knee replacement
- •Subject has presence of malignant tumor, metastatic, or neoplastic disease
- •Subject is not expected to return to normal ambulatory function (i.e., morbid obesity or other limiting co-morbidities)
- •Subject is pregnant or plans to become pregnant during the course of the study
- •Subject has conditions that may interfere with the revision arthroplasty survival or outcome (i.e., Paget's or Charcot-Marie-Tooth disease, vascular insufficiency, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease)
- •Subject has known (Subject reported) metal hypersensitivity
- •Subject has an emotional or neurological condition that would pre-empt their ability or willingness to participate in this study
- •Subject has BMI>45
- •Subject is participating in any other pharmaceutical, biologic, or medical device clinical investigation or has been treated with an investigational product in the past 30 days
- •Subject is facing current or impending incarceration
- •Subject is not a good candidate for the study based on Investigator opinion
结局指标
主要结局
Original Knee Society Clinical Score© (KSCS)
时间窗: 1 year
The original Knee Society Score© (KSS) is subdivided into two parts. One part is the Knee Society Clinical Score (KSCS) and the other part is the Knee Society Functional Score (KSFS). The KSCS will be administered at the pre-operative visit and all follow-up visits. The purpose of administering this assessment is to determine the statistical clinical improvement over time which may be compared to literature at 1 and 2 years.
Revision
时间窗: Up to 5 years
Revision, for any reason, will be assessed throughout the subject's participation in the study.
次要结局
- 2011 Knee Society Score©(2 years)
- Original Knee Society Functional Score© (KSFS)(2 years)
- EQ-5D-3L™(2 years)
- Original Knee Society Clinical Score© (KSCS)(2 Years)