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临床试验/NCT05482438
NCT05482438Unknown不适用

INFLUENCE OF SELECTED CLINICAL AND IMPLANT FACTORS ON THE RATE AND DISTRIBUTION OF WEAR OF POLYETHYLENE INSERT OF THE ARTIFICIAL KNEE JOINT

Valdoltra Orthopedic Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
Linear wear

研究概览

简要总结

The purpose of the study is to measure and compare the wear rates of retrieved PEI after failed TKA with respect to various causes for revision surgery, implant size, surgical and patient factors as well as to identify a characteristic linear wear distribution pattern of the articular surface in most common causes of TKA failure. Consequently, we want to contribute to a better understanding of wear mechanisms and identify a possible additional factor for increased PEI wear in TKA.

详细描述

INTRODUCTION / BACKGROUND The most common indications for revision (or causes for dissatisfaction) in total knee arthroplasty (TKA) include prosthetic joint infection (PJI), malposition of the implant, wear of the tibial polyethylene insert (PEI) and consequent induced osteolysis and aseptic loosening, mechanical failure, instability and stiffness of the prosthetic joint. Increased wear of PEI is the result of a multifactorial problem that involves factors from the implant, the surgeon, and the patient. There is also a large number of patients with failed knee arthroplasty where the exact cause for failure is not known. In these cases, probably, a single cause alone would not lead to a problem, but a combination of causes could generate severe dissatisfaction finally leading to revision without clearly defined diagnosis. The appropriate diagnosis in these knees might be extremely difficult to clarify.

Analyses on retrieved PEI allows for a better understanding of TKA failure mechanisms and the detection of factors that cause increased wear rates. There is a lack of research on homogeneous PEI samples, which are analyzed using modern methods and information on the 3D wear distribution of the articular surface in different clinical causes for TKA failure. To our knowledge, it has not been investigated, whether PEI size and the femur to PEI size ratio (within the manufacturer's guaranteed compatibility) affect the wear rate.

PURPOSE AND HYPOTHESIS The purpose of the study is to measure and compare the wear rates of retrieved PEI after failed TKA with respect to various causes for revision surgery, implant size, surgical and patient factors as well as to identify a characteristic linear wear distribution pattern of the articular surface in most common causes of TKA failure. Consequently, we want to contribute to a better understanding of wear mechanisms and identify a possible additional factor for increased PEI wear in TKA.

We expect increased polyethylene wear rates of prosthesis failed due to aseptic causes compared to those failed due to PJI and different linear wear distribution patterns in different failure causes. We expect higher wear rates in smaller PEI and in PEI with a lower femoral to PEI component size ratio (within the framework of the compatibility guaranteed by the manufacturer).

MATERIALS AND METHODS The study will include approximately 60 retrieved Sigma® Cruciate-Retaining Curved GVF i2 from DePuy Synthes (Johnson & Johnson, Warsaw, IN 46582, USA) PEIs, that were removed during the revision operation between 1.1.2013 (start of Institutional storage of removed knee endoprosthesis components) and 31.12.2021. The listed Sigma® PEI represents the largest share of inserted PEV in primary total knee arthroplasty in Valdoltra Orthopedic Hospital (VOH) in the last decade (from 1.1.2012 to 31.12.2021) and the highest number of single types retrieved PEIs in this period and represents the only reason why we selected this particular implant.

研究设计

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

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •primary TKA performed in Valdoltra Orthopedic Hospital (VOH), cement TKA, tibial component Sigma® Modular CoCr Tibia Tray Component (Non-Porous); tibial PEI Sigma® Cruciate-Retaining Curved GVF i2; femoral component Sigma® CR Femoral Component (Non-Porous); revision operation with PE insert removal performed in VOH and PE insert storage.

排除标准

  • •endoprosthesis fracture, missing patient, prosthesis type or course of primary and revision surgery data.

结局指标

主要结局

Linear wear

时间窗: 6 months

The linear wear rate will be calculated by dividing the wear by the component time in situ (time from primary TKA to revision operation) and given as mm/year.

Volumetric wear

时间窗: 6 months

The volumetric wear rate will be calculated by dividing the wear by the component time in situ (time from primary TKA to revision operation) and given as mm3 /year.

次要结局

未报告次要终点

研究者

发起方
Valdoltra Orthopedic Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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