NCT01359540已完成不适用
A Dual Energy X-Ray Absorptiometry (DXA) Evaluation Of Bone Density Changes After Hip Replacement. Performance Of The OMNI Apex Modular™ Hip Stem And The OMNI Apex ARC™ Hip Stem In Primary Total Hip Arthroplasty, Five-Year Clinical And DXA Analysis
Spokane Joint Replacement Center1 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2009年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Femoral bone mineral density
研究概览
简要总结
This study compares the change in bone density which occurs after hip replacement with different femoral stem devices.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Minimum age 20 years, maximum age 80 years
- •Osteoarthritis of the hip
- •Elective THA
- •Signed Informed Consent
排除标准
- •Osteoporosis
- •Revisions
- •Clinically obese (>40 body mass index [BMI])
- •Femoral dysplasia
- •Trochanteric osteotomy
- •Inflammatory arthritis
- •Breast-feeding, pregnancy, or women of childbearing potential without documentation of a negative pregnancy test and not utilizing contraception
- •Patients with a history of having taken or currently taking bisphosphonates, PTH, fluoride therapy or strontium ranelate or patients taking other chronic medications that in the investigator's opinion are known to affect bone mineral density in a substantial way
- •Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
- •Use of other investigational agent in the last 30 days
- •Unable to sign Informed Consent
结局指标
主要结局
Femoral bone mineral density
时间窗: Baseline, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative
Change in bone mineral density (BMD) as measured by DXA imaging.
次要结局
- Harris Hip Score (HHS)(Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative)
研究者
David F. Scott, MD
Principle Investigator
Spokane Joint Replacement Center
研究点 (1)
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