NCT02371382进行中（未招募）不适用
Multicentre Prospective Study to Evaluate Long-term Clinical Outcomes of the Sirius Cemented Femoral Stem
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Harris Hip Score
研究概览
简要总结
The purpose of this multicentre, prospective study is:
- Document the Clinical and Radiographic performance of the stem at 3 months, 1 year, 3 years, 5 years, 7 and 10 years.
- Report Safety and Survivorship up to 10 years F/up.
详细描述
This study intends to evaluate the safety and performance of the Sirus cemented hip stem in terms of function improvement postoperatively, stability and fixation of femoral stem and survivorship.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Selection of subjects for this evaluation should be in accordance with the indications of Sirus stem:
- •Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- •Rheumatoid arthritis
- •Correction of functional deformity
- •Treatment of non-union, femoral neck fracture and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
- •Revision procedures where other treatments or devices have failed. The Sirius Femoral Hip Stem is intended for cemented use only and may be used in partial and total hip arthroplasties
排除标准
- •Absolute contraindications include:
- •infection, sepsis, osteomyelitis
- •Additional contraindications include:
- •Uncooperative patient or patient with neurologic disorders who are incapable of following directions,
- •Osteoporosis,
- •Metabolic disorders which may impair bone formation
- •Osteomalacia
- •Distant foci of infections which may spread to the implant site
- •Rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram
- •Vascular insufficiency, muscular atrophy or neuromuscular disease.
结局指标
主要结局
Harris Hip Score
时间窗: 1 year
Change in Harris Hip Score from Baseline to 1 Year post-surgery, Harris Hip Score, 0-100 points. The higher the positive difference between baseline and follow up the better the result
次要结局
- Oxford Hip score(10 years)
研究者
研究点 (2)
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