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临床试验/NCT06821581
NCT06821581已完成不适用

Economic-demographic Assessment of the Aseptic Mobilization of Knee Prostheses Through the RIPO Registry and Radiographic Analysis of the Case Series From the II Clinic of IOR

Istituto Ortopedico Rizzoli1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2026年1月13日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
31
试验地点
1
主要终点
Demographic data

研究概览

简要总结

The increase in life expectancy is leading to an increase in the average age of patients undergoing total knee arthroplasty (TKA), and, consequently, an increase in the number of revisions. The main cause of TKA failure is aseptic mobilization, which is described as the loss of integration between the prosthetic component and the bone in the absence of infection. This represents a significant impact on professional and economic resources for the Italian healthcare system. Aseptic mobilization can be caused by inadequate initial fixation of the implant and/or mechanical or biological loss of fixation over time, factors that often occur simultaneously. A careful, methodical evaluation of post-operative radiographs of TKAs remains an important diagnostic tool. The analysis of the causes of aseptic mobilization of TKAs and the associated economic impact in the Emilia Romagna region is useful for providing an estimate of the problem and identifying potential areas for improvement.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing knee prosthesis revision for aseptic mobilization
  • Follow-up ≥ 2 years
  • Willingness to participate in the study
  • Both sexes
  • Patients ≥ 18 years old

排除标准

  • Patient refusal to participate in the study and sign the informed consent
  • Simultaneous participation in other studies

结局指标

主要结局

Demographic data

时间窗: 24 months

Collection of registry data related to the sample of patients undergoing TKA revision for aseptic mobilization, including demographic data

次要结局

  • Healthcare expenses(24 months)
  • Radiographic analysis(24 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefano Zaffagnini

Full Professor Medicine and Surgery, University of Bologna

Istituto Ortopedico Rizzoli

研究点 (1)

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