Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach: A Follow-up of a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Leg length
研究概览
简要总结
Uncemented Hemiarthroplasty, Radiological Features Comparing Lateral Versus Anterolateral Approach. Comparing leg length discrepancy, femoral offset, valgus/varus position of the stem. Also is there a difference in heterotopic ossification at 12 months.
详细描述
Between January 2014 and July 2017 a RCT was conducted at Sorlandet Hospital Kristiansand, Norway. The trial was approved by the regional ethics committee (2013/1853/REK) and registered at ClinicalTrials.gov (ClinicalTrials.gov Identifier NCT02028468). This study is a follow-up on the same study population.
150 patients (70 to 90 years) with a displaced femoral neck fracture was randomized to be operated With either anterolateral og Direct lateral surgical approach. Investigators want to compare the radiological features of the femoral stem between the two Groups.
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
- Double (Participant, Investigator)
盲法说明
Participants attempted masked.
入排标准
- 年龄范围
- 70 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 70 and 90 years of age with displaced femoral neck fractures
- •Intact cognitive function
- •Ability to walk with or without a walking aid prior to falling.
排除标准
- •Fractures in pathologic bone
- •Patients not belonging to the hospital community
- •Patients with sepsis or local infection
- •Fracture not eligible to be treated with a hemiarthroplasty
结局指标
主要结局
Leg length
时间窗: Immediately after surgery
The perpendicular distance between a horizontal line passing through the lower edge of the teardrop to the ipsilateral center of the femoral head
次要结局
- Canal fill ratio(Immediately after surgery)
- Valgus/varus stem position(Immediately after surgery)
- Heterotopic ossification(1 year)
- Femoral offset(Immediately after surgery)