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临床试验/NCT04247672
NCT04247672招募中不适用

The ATtune Knee Outcome Study: Prospective Evaluation of a Novel Uncemented Rotating Platform Total Knee Arthroplasty

Spaarne Gasthuis1 个研究点 分布在 1 个国家目标入组 900 人开始时间: 2020年2月3日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
900
试验地点
1
主要终点
Knee injury and Osteoarthritis Outcome Scale - Physical Function Short Form

研究概览

简要总结

To accomodate dissatisfied patients with a total knee arthroplasty (TKA) and improve outcomes, several knee systems have been developed. The cemented ATTUNE TKA shows superiority over other established knee systems at short-term, abating with longer follow-up. There have been no studies reporting on the results of the uncemented version of the ATTUNE. Therefore, the main objective of the current study was to report patient reported outcome measures (PROMs), survivorship and complications associated with the uncemented ATTUNE TKA.

详细描述

Every year, 1.5 million total knee arthroplasties (TKA) are performed worldwide in patients whose joints have been severely affected by osteoarthritis, rheumatoid arthritis, or trauma, causing intense pain and loss of function. Due to the ageing society, these numbers are expected to have increased six-fold to 3.48 million cases annually by 2030. Even though joint replacement provides satisfactory and durable results for most patients, 20% is thought to still not be satisfied with their artificial joint. To accommodate this dissatisfied population and improve durability of implants even more, several knee systems have been developed over the years. One of the newest models is the ATTUNE knee system (DePuy, Warsaw, Indiana, USA). One of the landmark features is a gradually reducing radius in the geometry of the femoral component, more closely mimicking the anatomical patellofemoral joint and facilitating more natural femoral rollback during flexion. Comparisons of the cemented ATTUNE with previous knee systems show promising results in terms of patellofemoral outcomes, but fail to demonstrate definitive superiority in terms of all patient reported outcomes. Clinical superiority of the ATTUNE tends to abate with longer follow-up, implicating a possible superiority in the short-term recovery and return to activities. There is no follow-up study reporting the results of the uncemented ATTUNE. Moreover, all previously cited studies report better patellofemoral outcomes with patellar resurfacing, making it still unclear whether the implicated superior design changes of the femoral component hold ground without patellar resurfacing.

The primary objective is to report survivorship, complications and patient reported outcome measures associated with the uncemented ATTUNE rotating platform knee system. Secondary objectives are (1) evaluate patient reported (patellofemoral) outcomes (2) assess return to work and sport after TKA (3) translate and validate the Dutch version of the University of California, Los Angeles (UCLA) activity scale and (4) analyse psychologic factors (such as pain catastrophising and coping) and the impact on dissatisfaction following TKA.

研究设计

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

入排标准

年龄范围
21 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • End-stage osteoarthritis of the knee warranting joint replacement therapy.
  • Indicated for an ATTUNE total knee system as part of regular clinical practice.
  • Capability and willingness to sign informed consent and comply with follow-up procedures.
  • Capable enough in Dutch or English to be able to understand study procedures

排除标准

  • Unable or unwilling to sign informed consent and comply with follow-up
  • Indication for primary revision arthroplasty
  • Absolute indication for cemented fixation (decreased bone stock/quality of spongiosa)

结局指标

主要结局

Knee injury and Osteoarthritis Outcome Scale - Physical Function Short Form

时间窗: 10 year

KOOS-PS

Complication rate

时间窗: 10 year

All substantial complications associated with total knee arthroplasty will be registered and reported

Survivorship

时间窗: 10 year

Calculated by determining revision rate. Septic, aseptic and all-cause revision rates will be calculated seperately.

Forgotten Joint Score 12 (FJS-12)

时间窗: 10 year

Kujala Anterior Knee Pain Scale (AKPS)

时间窗: 10 year

Numeric Rating Scale (NRS)

时间窗: 10 year

NRS on pain and satisfaction

EuroQol 5 Dimensions, 3 Levels (EQ5D-3L)

时间窗: 10 year

次要结局

  • Tegner activity rating scale(1 year)
  • University of California, Los Angeles (UCLA) activity rating scale(1 year)
  • Return to work(1 year)
  • Pain Self Efficacy Questionnaire (PSEQ)(10 year)
  • Stair climb test (SCT)(1 year)
  • 30 second chair stand test (30sCST)(1 year)
  • 40m Fast paced walk test (40m-FPWT)(1 year)
  • Alignment(1 year)
  • Patient Health Questionnaire (PHQ-2)(10 year)
  • Pain Catastrophizing Scale (PCS)(10 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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