Randomized Controlled Trial Comparing a Short Uncemented Femoral Stem to a Similar Standard Uncemented Femoral Stem
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- stem subsidence
研究概览
简要总结
This randomized controlled trial will compare patients receiving a standard uncemented femoral stem with patients receiving an identically designed short uncemented femoral stem.
详细描述
This randomized controlled trial will compare patients receiving a standard uncemented femoral stem with patients receiving an identically designed short uncemented femoral stem.
Patients will be randomized a few days before the operation. At the time of surgery, the surgeon will use the relevant implant. Patients will be followed up for 5 years after surgery. The main outcome criteria is the stem subsidence measured radiographically with a dedicated software.
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 (Participant)
盲法说明
implant
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
- •hip osteoarthritis requiring a total hip replacement
- •>18 years old
- •agrees to participate
排除标准
- •total hip replacement not indicated
- •general anesthesia contraindicated
- •previous surgery on the ipsilateral femur
- •follow-up not possible
结局指标
主要结局
stem subsidence
时间窗: 2 years postop
stem subsidence will be measured using the EBRA (Ein-Bild-Rontgen-analyse) software on postoperative antero-posterior radiographs (5 xrays from day one to year 2)
次要结局
- Intraoperative surgeon satisfaction(intraoperative)
研究者
Dr David BIAU
Professor
Association pour le Développement et l'Enseignement de la Chirurgie Réparatrice et Orthopédique