Comparison of Functional Recovery After Pertrochanter Fracture Treated With Either Total Hip Replacement or Centromedullary Nailing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Harris Score
研究概览
简要总结
This is a single-centre, comparative, prospective randomised trial. It will include 70 patients over a period of 2 years randomized into two groups of 35 patients: one group of patients treated with osteosynthesis (plate, nail or screw) and the second group treated with total hip replacement.
The Harris and PMA functional scores will be assessed at 6 weeks, 3 months, 6 months and 1 year.
The time to recovery of weight-bearing, the subjective satisfaction score, the EQ5D quality of life questionnaire, the VAS score for pain at rest and when walking, the Parker score, the rate of complications and deaths will also be measured. Operating time, blood loss and scar size will also be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
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
- •Patients who have provided written informed consent
- •Patients over 18 years old
- •Patients less than 70 years old
- •Patient presenting with a fracture of the trochanter (type 1 to 6 according to the Ender classification, and A1 and A2 according tyo the AO classification (Association suisse pour l'étude de l'Ostéosynthèse : classification internationale)
排除标准
- •Adult under guardianship
- •Patients not covered by national health insurance
- •Pregnant or breast-feeding women
- •Unable to walk independently before the trauma
- •Patients with dementia
研究组 & 干预措施
Patients treated with total hip replacement
干预措施: Total hip replacement (Procedure)
Patients treated with osteosynthesis
干预措施: Osteosynthesis (Procedure)
结局指标
主要结局
Harris Score
时间窗: At 6 months after surgery
Functional hip score
次要结局
- Parker score(Up to 1 year after surgery)
- Subjective satisfaction score (EQ5D, VAS score for pain at rest and when walking)(Up to 1 year after surgery)
- PMA functional score(Up to 1 year after surgery)
- Rate of complications (loosening of implants, fractures around osteosynthesis devices or prostheses, infections, phlebitis-pulmonary embolism)(Up to 1 year after surgery)
- Time to recovery of weight-bearing(Up to 1 year after surgery)
- Death rate(Up to 1 year after surgery)