NCT04884542招募中不适用
A Prospective, Post-marketing Study Evaluating Clinical and Radiographic Early Outcomes of Revision Total Knee Arthroplasty with Multigen Plus H Alone or Involving AMF TT Cones.
Limacorporate S.p.a2 个研究点 分布在 2 个国家目标入组 43 人开始时间: 2022年1月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Functional Knee Society Score (KSS)
研究概览
简要总结
The aim of this study is to assess the clinical, patient-reported, and radiographic outcomes of a revision Total Knee Arthroplasty with Multigen Plus H and AMF TT Cones.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or female
- •Age ≥ 18 years old
- •Given written informed consent approved by the reference Ethics Committee (EC)
- •Subjects in whom a decision has already been made to perform a Total Knee Arthroplasty with the Multigen Plus H system as per Indication For Use. The decision to implant a Multigen Plus H system, alone or involving the AMF TT cones, must be taken prior to, and independently from, the decision to enrol the subject. This decision should be made in accordance with routine clinical practice at the study site concerned.
- •Subject is able to comply with the protocol
排除标准
- •Age < 18 years old
- •Subjects with any Multigen Plus system contraindication for use, or any AMF TT cones contraindication for use when used in combination with the Multigen Plus H, as reported in the current Instruction For Use.
- •Any clinically significant pathology based on the medical history or any medical intervention that the Investigator feels may affect the study evaluation
- •Female subjects who are pregnant, nursing, or planning a pregnancy
- •Previous knee replacement on the contralateral side within the last year and whose outcome is achieving an KSS < 70 points.
结局指标
主要结局
Functional Knee Society Score (KSS)
时间窗: Month 24
Evaluation of the changes in the Functional Knee Society Score (KSS) after revision TKA
次要结局
- Radiographic implant evaluation and stability assessment(Month 24)
- KOOS-ADL (Function in Daily Living subdomain)(Month 24)
- Safety evaluation(Intra-operatively, Month 3, Month 12, and Month 24)
- VAS Pain score(Month 24)
- Survivorship of the implant(Month 24)
研究者
研究点 (2)
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