跳至主要内容
临床试验/NCT00588861
NCT00588861终止不适用

Total Hip Replacement With the Answer® Hip Stem and Ranawat/Burnstein® Acetabular Shell Using Simplex® or Palacos® Bone Cement

Biomet Orthopedics, LLC2 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2002年9月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
400
试验地点
2
主要终点
Harris Hip Score

研究概览

简要总结

The purpose of this study is to document the clinical outcomes of several devices used in total hip replacement, including the Answer® hip stem, the Ranawat/Burnstein® acetabular shell, and Simplex® or Palacos® bone cement.

详细描述

The purpose of this study is to document the clinical outcomes of several devices used in total hip replacement, including the Answer® hip stem, the Ranawat/Burnstein® acetabular shell, and Simplex® or Palacos® bone cement. It was desirable to see if there were any differences in the outcomes of two different types of bone cement in application.

研究设计

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

入排标准

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

入选标准

  • Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis
  • Rheumatoid arthritis
  • Correction of functional deformity
  • Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques

排除标准

  • Infection, sepsis, and osteomyelitis

结局指标

主要结局

Harris Hip Score

时间窗: 10 Years Post-Operative

The Harris Hip Score is detailed below as a range. 100 being the highest score, and 0 being the lowest score. 90-100 is considered "Excellent." 80-89 is considered "Good." 70-79 is considered "Fair." Less than 70 is considered "Poor."

次要结局

  • Harris Hip Score Pain(Pre-Operative, 6 months, 1 year, 2 year, 4 year, 6 year, 8 year, 10 year)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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