临床试验/NCT04995679

NCT04995679已完成不适用

Residual Pain After Successful Implant of Metaphyseal Sleeves in Total Knee Arthroplasty: a Case Series of 50 Patients With Long-term Follow-up

University of Milan2 个研究点分布在 1 个国家目标入组 85 人开始时间: 2019年7月15日最近更新: 2021年8月9日

适应症

试验速览

阶段: 不适用
状态: 已完成
发起方: University of Milan
入组人数: 85
试验地点: 2
主要终点: Evaluation of implant's survivorship

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

: Total knee revision arthroplasty is increasing in daily practice and will become more relevant in the years to come. Bone loss is a significant challenge in total knee arthroplasty (TKA) especially in revision procedures. Metaphyseal sleeves are widely used to bypass bone loss and improve stability. This study aims to report the results of primary and revision TKA (R-TKA) using metaphyseal sleeves.

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

•Patients were included if they were older than 18 years and underwent a primary or revision TKA using cement-less metaphyseal sleeves, performed by the same senior surgeon

排除标准

•Patients were excluded from the final analysis if they did not have 18 months of minimum follow-up and if they were lost to the final control.

结局指标

主要结局

Evaluation of implant's survivorship

时间窗: 7 years

A retrospective study was performed on patients who underwent TKA or Revision TKA using tibial and/or femoral metaphyseal sleeves to evaluate the implant's survivorship

次要结局

Evaluation of Numerical Rating Scale (NRS)(7 years)
Evaluation of Western Ontario and Mc Master University (WOMAC)(7 years)
Evaluation of Oxford Knee Score (OKS)(7 years)

研究者

发起方

University of Milan

申办方类型

Other

责任方

Principal Investigator

主要研究者

Pietro Randelli, MD

Professor

University of Milan

研究点 (2)

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