NCT03720782进行中（未招募）不适用
Multi-center Study of the Safety and Performance of Primary Total Knee Arthroplasty With LEGION™ Porous HA Tibial Baseplates (With and Without Holes) and/or the LEGION™ Porous HA CR Femoral Component in US Centers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 118
- 试验地点
- 4
- 主要终点
- Implant survivorship 10 years post-surgery
研究概览
简要总结
The purpose of this research is to collect data on patients that had the Legion Porous HA Tibial Baseplates and/or the Legion Porous HA Femoral component implanted in the past. Smith & Nephew will evaluate the safety and performance of these implants for 10 years post-surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Subject received primary TKA with the LEGION Porous HA Tibial Baseplates (either with holes or without holes) and/or the LEGION Porous HA CR Femoral Component, due to degenerative joint disease (primary diagnosis of osteoarthritis, post-traumatic arthritis, or degenerative arthritis).
- •Subject received primary TKA between 24 and 60 months prior to the time of consent.
- •Inclusion criteria for prospective follow-up (subjects must meet criteria 1 & 2 from above and criteria 3,4 and 5 below):
- •Subject agrees to consent and to follow the prospective study visit schedule (as defined in the study protocol and informed consent form) by signing the IRB/IEC approved informed consent form.
- •Subject must be available through ten (10) years postoperative follow-up.
- •Subject is able to read, understand, and communicate responses to Patient Reported Outcome assessments in English.
排除标准
- •Exclusion criteria for retrospective chart review - Any one (1) of the following criteria will disqualify a potential subject from participation in the retrospective chart review:
- •Subject received TKA on the contralateral knee as a revision for a previously failed total or unicondylar knee arthroplasty
- •Subject has ipsilateral hip arthritis resulting in flexion contracture.
- •At the time of enrollment, subject has one or more of the following arthroplasties that are not fully healed and well-functioning, as determined by the investigator: Ipsilateral or contralateral primary total hip arthroplasty or hip resurfacing arthroplasty; Contralateral primary total knee or unicondylar knee arthroplasty.
- •Subject has a condition that may interfere with the TKA survival or outcome (e.g. Paget's or Charcot's disease, vascular insufficiency, lupus, muscular atrophy, uncontrolled diabetes, moderate to severe renal insufficiency or neuromuscular disease).
- •Subject has a known allergy to one or more of its components of the study device.
- •Subject is entered in another drug, biologic, or device study or has been treated with an investigational product in the past 30 days.
- •Exclusion criteria for prospective follow-up - Any one (1) of the criteria from 1-6 above will disqualify a potential subject from participation in the prospective follow-up) as will any one (1) of the below criteria 7, 8 and 9:
- •Subject, in the opinion of the Principal Investigator (PI), has an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, mental retardation, drug or alcohol abuse.
- •Subject is known to be at risk for loss to follow-up, or failure to return for scheduled visits.
- •Subject is found to have had a revision of the study device(s).
结局指标
主要结局
Implant survivorship 10 years post-surgery
时间窗: 10 years
次要结局
- Quality of Life - Forgotten Joint Score (FJS)(10 years)
- Quality of life - KOOS JR(10 years)
- Quality of life - EQ-5D-5L(10 years)
- Radiographic findings(10 years)
- Implant survivorship(5 years)
研究者
研究点 (4)
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