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临床试验/NCT05623215
NCT05623215进行中(未招募)不适用

Comparing the Migration and Inducible Displacement Through RSA of the Cementless ATTUNE Rotating Platform and the Cementless LCS Rotating Platform Knee System; A Clinical Randomized Controlled RSA Follow-up Study

Spaarne Gasthuis1 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2022年11月10日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
49
试验地点
1
主要终点
Change from baseline migration of the prostheses

研究概览

简要总结

The cementless ATTUNETM Rotating Platform Knee system was compared in a single-blind, randomized RSA trial to its predecessor, the LCS rotating platform Knee System. In this previous study, 61 knees were subjected to RSA examinations at 1-day and 3, 6, 12 and 24 months postoperative. This study found a promising equal migration of both tibial components and a lesser migration of the femoral component of the ATTUNETM knee system after two years, although with a similar migration rate between year 1 and 2. this raises the question of whether the migration of the prostheses relative to each other will increase or remain the same in the long term. To examine this, a mid-and long-term RSA follow-up to measure migration is necessary. In addition, another new RSA measurement parameter has become known in recent years that may provide an indication of the bonding of the prosthesis to the bone at the time of measurement. This new parameter, called the Induced Displacement (ID) of a prosthesis, measures the position and orientation relative to the bone while the prosthesis is under different loading conditions (e.g., patient in supine or standing position). This means that a large measured difference between these different loading condition measurements would indicate that osseointegration of the prosthesis never occurred or is no longer present. To improve the understanding of the tendency of both prostheses to aseptic loosening after a mid- to long-term follow up, migration over time and inducible displacement analyses are necessary.

The primary objective of this study is to accurately compare mid- and long-term migration of two uncemented TKR prostheses. The secondary objectives of this study are to evaluate if inducible displacement can be used as a parameter to detect loose implants, and to compare inducible displacement, clinical and radiological outcome and patient-reported outcomes (PROMS) after a follow-up of 5 and 10 years of two uncemented TKR prostheses.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • In order to be eligible to participate in this study, a subject must meet all of the following criteria:
  • The Patient participated in the initial study (NL58911.058.16) [1].
  • The patient is capable of giving informed consent and expressing a willingness to comply with the study.

排除标准

  • A potential subject who meets any of the following criteria will be excluded from participation in this study:
  • The patient underwent a major revision TKR (exchange of the tibial or femoral component).
  • The patient is unable or unwilling to sign the informed consent specific to this study.

结局指标

主要结局

Change from baseline migration of the prostheses

时间窗: 5 years post TKA

Migration is measured and expressed in translations, rotations, and MTPM; MTPM is the point of the prosthesis that has moved most.

Ten year change from baseline migration of the prostheses

时间窗: 10 years post TKA

Migration is measured and expressed in translations, rotations and MTPM; MTPM is the point of the prosthesis that has moved most.

次要结局

  • Inducible displacement(10 years post TKA)
  • Numeric Rating Scale (NRS)(10 year post TKA)
  • EuroQol 5D-5L (EQ-5D-5L)(10 year post TKA)
  • Knee injury and Osteoarthritis Outcome Scale Physical Function Short-form (KOOS-PS)(10 year post TKA)
  • Oxford-12 Knee Score (OKS)(10 year post TKA)
  • Kujala Anterior Knee Pain Scale (AKPS)(10 year post TKA)
  • Anchor questions(10 year post TKA)

研究者

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

Raymond Puijk

drs

Spaarne Gasthuis

研究点 (1)

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