跳至主要内容
临床试验/NCT00764842
NCT00764842终止不适用

Post-Market Study: The Efficacy of the CLP® Hip

Encore Medical, L.P.1 个研究点 分布在 1 个国家目标入组 61 人开始时间: 2008年1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
61
试验地点
1
主要终点
The survivorship and efficacy of the Encore CLP® Hip stem

研究概览

简要总结

The purpose of this study is to evaluate the survivorship and efficacy of the Encore CLP® Hip stem in a group of no more than 200 patients from whom data has already been collected.

研究设计

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

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

  • Patients must be 18 years of age or older.
  • Noninflammatory degenerative joint disease including
  • Osteoarthritis of the natural femoral head
  • Avascular necrosis of the natural femoral head
  • Rheumatoid arthritis
  • Correction of functional deformities
  • Femoral fracture
  • Patients must be able and willing to complete all study-related visits.

排除标准

  • Anyone who is under 18 years of age
  • Infection or sepsis
  • Insufficient bone quality which may affect the stability of the implant
  • Muscular, neurological or vascular deficiencies, which compromise the affected extremity
  • Skeletally immature patients and cases where there is a loss of abductor musculature, poor bone stock, poor skin coverage around hip joint which would make the procedure unjustifiable
  • Osteomyelitis
  • Rapid joint destruction or bone absorption apparent on roentgenogram
  • Pathological conditions of the acetabulum which would prevent achieving proper range of motion, appropriate head stability, and/or a well-seated and supported smooth articulation of the head within the acetabulum
  • Alcoholism or other addictions
  • Materials sensitivity
  • Loss of ligamentous structures
  • High levels of physical activity (e.g., competitive sports, heavy physical labor)

结局指标

主要结局

The survivorship and efficacy of the Encore CLP® Hip stem

时间窗: 2 year

次要结局

未报告次要终点

研究者

申办方类型
Industry

研究点 (1)

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Efficacy of the CLP® Hip - Retrospective | 临床试验