NCT02748408招募中不适用
The Medacta SMS Femoral Stem Component. A Multi-National, Multi-Centre, Clinical Surveillance Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 550
- 试验地点
- 4
- 主要终点
- survivorship of the Medacta SMS femoral stem
研究概览
简要总结
This is a Post-Marketing Surveillance of SMS femoral stem prosthesis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with a severely painful and/or disabling hip joint with osteoarthritis, traumatic arthritis or developmental dysplasia of the hip or avascular necrosis of the femoral head.
- •In order to take part in this study, all study participants must be between the ages of 18 and 75 years of age, at the time of surgery.
- •Scheduled for a primary total hip replacement.
排除标准
- •Active infection
- •Pregnancy
- •Mental illness where the known condition is likely to compromise the patient's ability to consent, affect the patient's assessment of their progress or complete the 10 year cycle of follow-up appointments and reviews
- •Grossly distorted anatomy (surgeon's discretion)
- •Osteomalacia where uncemented implant fixation is contraindicated
- •Active rheumatoid arthritis.
- •Osteoporosis
- •Metabolic disorders which may impair bone formation where uncemented implant fixation is contraindicated
- •Muscular atrophy or neuromuscular disease
- •Allergy to implant material
- •Any patient who cannot or will not provide informed consent for participation in the study
- •Those whose prospects for a recovery to independent mobility would be compromised by known coexistent, medical problems
结局指标
主要结局
survivorship of the Medacta SMS femoral stem
时间窗: 10-year
次要结局
- clinical performance(3, 5, 7 and 10 years)
- radiographic performance(3, 5, 7 and 10 years)
- Adverse events(up to 10 years)
- Evaluate the patient satisfaction(6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 years)
- Evaluate the quality of life(6 months, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 years)
- pattern of bone remodeling(6 weeks, 6 months, 1 year)
- stem migration(6 weeks, 6 months, 1 and 2 years)
研究者
研究点 (4)
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