A Prospective Randomized Trial of Uncemented Versus Cemented Hemiarthroplasty for Displaced Femoral Neck Fractures
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 230
- 试验地点
- 4
- 主要终点
- Functional outcome including pain (Harris Hip Score)
研究概览
简要总结
There is increasing evidence that primary hemiarthroplasty is the treatment of choice for displaced femoral neck fractures in the elderly
No definite conclusions have been made in regards to what kind of arthroplasty is favourable
Cemented implants are associated with increased risk of perioperative cardiovascular incidents and increased mortality.
Cementless implants are associated with increased postoperative pain and decreased walking ability.
This study investigates the differences between one well-documented cemented femoral stem and one well-documented uncemented femoral stem. Previous studies have mostly used uncemented stems with different designs.
Null hypothesis: No (less than 10 points) difference in HHS between groups at 1 year and 5 years
详细描述
Inclusion Criteria: Dislocated intracapsular femoral neck fracture in patients ≥ 70 years old Exclusion criteria: Pathological fracture, Systemic or local infection, Short life expectancy/not mobile at all, Symptomatic coxarthrosis.
Null hypothesis: No (less than 10 points) difference in HHS between groups at 1 year (SD of HHS is 15 points) Power: 95% Significance: 0.05 60 patients in each group needed. To compensate for high mortality and drop-out: 200 patients, 100 in each group
Randomized using www.randomization.org to create sealed opaque envelopes opened at inclusion after signed informed concent.
Recorded after surgery:
Operating time Arthroplasty components used Need of blood transfusion Blood loss Size of incision
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Dislocated intracapsular femoral neck fracture
- •≥ 70 years old
排除标准
- •Pathological fracture
- •Systemic or local infection
- •Short life expectancy/not mobile at all
- •Symptomatic coxarthrosis
结局指标
主要结局
Functional outcome including pain (Harris Hip Score)
时间窗: 5 years
次要结局
- All Cause Mortality(5 years)
- Activities Of Daily Living (Barthels ADL-Index)(5 years)
- Quality Of Life (EQ-5D)(5 years)
- Any treatment related complication(5 years)