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临床试验/NCT01398800
NCT01398800已完成不适用

Early Clinical Results of Mobile-Bearing Revision Total Knee Arthroplasty

Colorado Joint Replacement1 个研究点 分布在 1 个国家目标入组 340 人开始时间: 2011年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
340
试验地点
1
主要终点
Function and knee score of the knee society scoring at every 2 years until 10 years.

研究概览

简要总结

Long term follow-up is needed to determine whether current Mobile Bearing revision Total Knee Arthroplasty (TKA) designs will improve implant longevity. The potential advantages of mobile bearings in the revision TKA setting include reduction in polyethylene wear, decreasing fixation stresses, and protection of the constraining mechanisms. Several studies have reported satisfactory clinical results after revision total knee arthroplasty but no study with a large number has specifically addressed the clinical outcomes after revision total knee arthroplasty using the mobile bearing design

详细描述

Failure modes of revision total knee arthroplasty (TKA) that include prosthetic loosening and damage to constraining mechanisms often require revision TKA. Mobile bearing revision TKA components have been developed in hopes of lessening these failure mechanisms. Our purpose is to evaluate the use of mobile bearings in revision TKA.

Retrospective clinical and radiographic evaluation of 340 revision mobile bearing TKAs using the PFC Sigma and LCS posterior stabilized rotating platform implants (Depuy, Warsaw, IN) will be performed. Indications for revision include instability, loosening, arthrofibrosis, chronic hemarthrosis, failed patellofemoral replacement, failed unicompartmental knee replacement, infection reimplantation, and supracondylar fracture nonunion.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Requiring a revision of a primary knee replacement. Indications for revision include instability, aseptic loosening, failed unicompartmental knee replacement, infection reimplantation, arthrofibroisis, chronic hemarthrosis, failed patellofemoral replacments, and non union of a supracondylar femur fracture.

排除标准

  • None since they have all required a revision.

结局指标

主要结局

Function and knee score of the knee society scoring at every 2 years until 10 years.

时间窗: 1-10 years post operative of revision

Follow up data of 1,2,4,6,8,and 10 years to evaluate bearing complications and clinical results for the use of MB in revision TKA. Retrospective clinical and radiographic evaluation of 197 mobile bearing revision TKA's will be collected. We will also analyze patient demographics and reason for revisions as well as implants used in revision.

次要结局

  • Radiographic analysis by our orthopedic clinician to determine component failure or loosening.(Post op - 1-10 years or revision surgery)

研究者

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

Donnis Rafferty

Dr. Raymond Kim

Colorado Joint Replacement

研究点 (1)

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