NCT00958347终止不适用
Omnifit Hydroxylapatite (HA) Hip Outcomes Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 226
- 试验地点
- 7
- 主要终点
- Patients Will be Evaluated for Pain, Functional Level, and Clinical Complications Utilizing the Harris Hip Score.
研究概览
简要总结
The purpose of this study was to obtain up to 25 year post-operative data on the Omnifit Hydroxylapatite (HA) Hip System in support of the hypothesis that it is a satisfactory system for reducing implant loosening, permitting tissue bonding onto the hydroxylapatite surfaces of the implant and providing a safe, efficient, and well-functioning hip in a wide spectrum of clinical circumstances.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- 否
入选标准
- •For use as a universal hip replacement:
- •Acute femoral neck fracture.
- •Non-union of femoral head and neck fractures.
- •Aseptic necrosis of the femoral head.
- •Osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis of the hip with minimal acetabular involvement or distortion.
- •Salvage of failed total hip arthroplasty.
- •For use as a total hip replacement:
- •Severely disabled joints resulting from painful osteoarthritis, rheumatoid arthritis, or post-traumatic arthritis.
- •Revision of previous unsuccessful femoral head replacement, cup arthroplasty, or other procedure.
排除标准
- •Active infection in or near the hip joint.
- •Pathological bone conditions which would significantly compromise the ability to carry physiologic stress levels and for which bone grafting would be inappropriate (i.e. severe osteoporosis, Paget's Disease, renal osteodystrophy, etc.).
- •Neuro-muscular disorders in which the potentially adverse effects on prosthesis function are not outweighed by the benefits to be gained by the patient from usage of the implant.
- •Mental disorders which would compromise essential patient post-operative care.
- •Skeletal immaturity.
- •Extreme obesity.
- •Significant probability that patient could not return for required follow-up evaluations.
结局指标
主要结局
Patients Will be Evaluated for Pain, Functional Level, and Clinical Complications Utilizing the Harris Hip Score.
时间窗: 25 Years Post-Operatively
次要结局
未报告次要终点
研究者
研究点 (7)
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