A Comparison of Two Different Surgical Techniques for Total Hip Resurfacing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- RSA
研究概览
简要总结
This study compares the posterior approach to the anterolateral approach using the ReCap® Total Hip Resurfacing System.
详细描述
Theoretical considerations of RECAP procedures through anterolateral trochanteric osteotomy:
- Less bone resection, less complicated revision surgery.
- Reduced stress shielding of the femur.
- Lower incidence of hip dislocations.
- Walking function improved by change in mobilisation regime and operative technique.
- Risk of femoral neck fracture is reduced by preoperative measurement of bone density.
- Risk of avascular necrosis of the femoral head is reduced with the anterolateral approach preserving femoral head blood supply and preventing later failure of the implant.
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
- None
入排标准
- 年龄范围
- 29 Years 至 61 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary hip OA
- •Secondary hip OA due to mild and moderate acetabular dysplasia
- •Sufficient bone quality for cementless acetabular component
- •Suited for resurfacing of the femoral head (pre- and intraoperatively assessed)
- •>29 years
- •<61 years
排除标准
- •Neuromuscular or vascular diseases in affected leg
- •Patients found intra-operatively to be unsuited for a cementless acetabular component or cementing of the femoral component
- •Need of NSAID post-operatively
- •Fracture sequelae
- •Females at risk of pregnancy (no safe contraceptives)
- •Severe hip dysplasia
- •Sequelae from hip disease in childhood
- •Medicine with large effect on bone density (K-vitamin antagonists, loop-diuretic)
- •Alcoholism (females > 14 units per week, males > 21 units per week) AVN
- •Osteoporosis
研究组 & 干预措施
1
This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System.
干预措施: Anterolateral approach (Procedure)
1
This arm utilizes the anterolateral approach using the ReCap® Total Hip Resurfacing System.
干预措施: ReCap Total Hip Resurfacing (Device)
2
This arm utilizes the posterior approach using the ReCap® Total Hip Resurfacing System.
干预措施: Posterior approach (Procedure)
2
This arm utilizes the posterior approach using the ReCap® Total Hip Resurfacing System.
干预措施: ReCap Total Hip Resurfacing (Device)
结局指标
主要结局
RSA
时间窗: 1 week, 3 months, 1 year, 2 years, 5 years
次要结局
- Microdialysis(1 week)
- DEXA scan(Pre-operatively, 1 week, 1 year, 2 years)
- Conventional X-ray(1 week)
- Gait Analysis(1 week, 3 months, 1 year)
- Harris Hip Score(Pre-operatively, 1 week, 6 weeks, 3 months, 1 year)