跳至主要内容
临床试验/NCT00306930
NCT00306930已完成不适用

Multi-center, Prospective, Clinical Evaluation of Pinnacle Acetabular Implants in Total Hip Arthroplasty

DePuy Orthopaedics2 个研究点 分布在 1 个国家目标入组 1,593 人开始时间: 2000年7月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,593
试验地点
2
主要终点
Survivorship

研究概览

简要总结

This study is a clinical evaluation of survivorship of an acetabular cup system after total hip replacement using patient examinations and questionnaires.

详细描述

The primary objective of this investigation is to evaluate survivorship at five years of the Pinnacle™ acetabular cup system in primary total hip arthroplasty.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Primary hip replacement
  • Sufficient bone stock to support implant
  • Signed Informed Patient Consent form

排除标准

  • Prior renal transplant
  • History of active joint sepsis
  • Recent high dose of corticosteroids
  • Primary or secondary carcinoma in the last 5 years
  • Neurological disease
  • Psychosocial disease that would limit rehabilitation
  • Use of structural bone graft
  • Simultaneous participation in another hip study

结局指标

主要结局

Survivorship

时间窗: 5 years

次要结局

  • Harris Hip Score(Pre-operative, 6 month and 1, 2, 3, 4, and 5 years.)
  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)(Pre-operative, 6 month and 1, 2, 3, 4 and 5 years.)
  • Short Form-36 (SF-36)(Pre-operative, 6 month and 1, 2, 3, 4 and 5 years.)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (2)

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