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临床试验/NCT04772625
NCT04772625进行中(未招募)不适用

Failure Analysis of Patellofemoral Arthroplasty

Anders Odgaard1 个研究点 分布在 1 个国家目标入组 550 人开始时间: 2019年1月1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)
发起方
入组人数
550
试验地点
1
主要终点
Implant revision and reoperation rates

研究概览

简要总结

The purpose of the retrospective cohort study is 1) to determine preoperative risk factors for revision af patellofemoral arthroplasty, and 2) to provide a detailed description of indications for revision after patellofemoral arthroplasty. All patients operated with patellofemoral arthroplasty in Denmark from January 1, 2008 to December 31, 2015, will be included in the cohort.

详细描述

Approx. 11,000 operations with the insertion of a knee arthroplasty (knee prosthesis) are performed annually DK. The durability and quality of the treatment are assessed with prosthesis survival, that expresses the proportion of prostheses that are still functional after a given number of years (eg the 10-year prosthesis survival for all types of knee prostheses in DK is approximately 94%).

Unicompartmental implants are increasingly used, so that only the worn part of the knee is replaced. Especially for osteoarthritis between the patella and the femur, a patellofemoral prosthesis (PFA - patellofemoral alloplasty) can be inserted, which is much smaller than the traditional full prosthesis (TKA - total knee arthroplasty).

PFA operations are controversial. A recently published Danish study (double-blind RCT) comparing TKA and PFA has shown that PFA patients achieve greater satisfaction, better knee function and greater quality of life than TKA patients. A recent study has also demonstrated that the cost of a PFA procedure is less than that of a TKA. As a paradox to this clear RCT finding, all national implant registers (Sweden, England, New Zealand, Denmark, etc.) show a significantly poorer prosthesis survival for PFA compared with TKA.

It is important for the future treatment of patients with severe osteoarthritis between the patella and femur to understand the cause of the discrepancy between RCT and registry results. The discrepancy gives rise to a number of questions regarding. indications, techniques, competences, postoperative regimens etc.

The divergence between the RCT and registry studies can only be clarified by a study that 1) examines the influence of preperative factors (patient history, physical findings, radiology etc.) on outcome, and that 2) attempts a causal analysis for each reoperation. The investigators intend to do this though a cohort study including all cases of patellofemoral arthroplasty performed in Denmark from January 1, 2008 until December 31, 2015.

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

入选标准

  • Patellofemoral arthroplasty
  • Primary procedure performed between Jan 1 2008 and Dec 31 2015
  • Primary procedure performed in Denmark

排除标准

  • Patella-nail syndrome
  • Dislocating tendon following patellectomy.

结局指标

主要结局

Implant revision and reoperation rates

时间窗: 10-year

The proportion of revised and reoperated patients

次要结局

  • The 6-year cumulative revision rate(6 years)

研究者

发起方
Anders Odgaard
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Anders Odgaard

Professor

Rigshospitalet, Denmark

研究点 (1)

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