跳至主要内容
临床试验/NCT04740749
NCT04740749终止不适用

Longevity, Functional Status and Quality of Life of the Compress® Compliant Pre-Stress System: a Prospective Study

Universitaire Ziekenhuizen KU Leuven2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
200
试验地点
2
主要终点
Compress device survival

研究概览

简要总结

In the treatment of malignant bone tumors, it may be necessary to remove large areas of the femur. To replace these large parts of missing bone, a prosthesis can be used. One innovative technology developed by Biomet is the Compress® Compliant Pre-Stress System (CPS; Zimmer-Biomet, Warsaw, USA). This fixation device uses compression, via a short traction bar, to stimulate osteointegration at the bone-prosthetic interface, promote hypertrophy of the loaded bone, and avoid stress bypass of the host bone around a stiff intramedullary stem. Young patients cured of tumors have a long life expectancy and a compelling need for prosthetic fixation that is equally durable. Good bone fixation is a prerequisite for implant longevity.

Although the initial results are encouraging, there is a need for additional mid- to long-term survival data from larger patient series showing longevity of the system, as well as reporting of functional outcome. Furthermore, to the best of our knowledge, no study examining the survival of the device using prospective data already exists. In addition, no studies were found examining the quality of life of the patients with the CPS system.

详细描述

In the treatment of malignant bone tumors, it may be necessary to remove large areas of the femur. To replace these large parts of missing bone, a prosthesis can be used. One innovative technology developed by Biomet is the Compress® Compliant Pre-Stress System (CPS; Zimmer-Biomet, Warsaw, USA). This fixation device uses compression, via a short traction bar, to stimulate osteointegration at the bone-prosthetic interface, promote hypertrophy of the loaded bone, and avoid stress bypass of the host bone around a stiff intramedullary stem. Young patients cured of tumors have a long life expectancy and a compelling need for prosthetic fixation that is equally durable. Good bone fixation is a prerequisite for implant longevity. Since 1999, the CPS has been routinely placed on the orthopedics - UZ Leuven service and, as a result, more than 100 patients have been treated in this way. However, there are only few studies reporting on long-term performance of this system. In addition, limited data reporting functional outcome were found.

Although the initial results are encouraging, there is a need for additional mid- to long-term survival data from larger patient series showing longevity of the system, as well as reporting of functional outcome. Furthermore, to the best of our knowledge, no study examining the survival of the device using prospective data already exists. In addition, no studies were found examining the quality of life of the patients with the CPS system.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
7 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients are/will be operated from 26/08/1999 onwards in UZ Leuven
  • Implantation of the Compress Compliant Pre-Stress Device
  • Informed consent obtained
  • Patients are able to complete the questionnaires
  • Age: minimum 7 years old

排除标准

  • 未提供

结局指标

主要结局

Compress device survival

时间窗: 25 years

Revision will be used to determine implant survival. Revision will be defined as the explantation of any fixation mechanism: anchor plug, traction bar, spindle, sleeve, fixation pin

次要结局

  • Partial weight-bearing (crutches): duration(25 years)
  • Functional status(25 years)
  • Postoperative complications(25 years)
  • Radiography: signs of osseointegration(25 years)
  • EORTC Core Quality of Life questionnaire (QLQ-C30)(25 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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