Prospective Randomized Comparison of Bipolar Hemiarthroplasty and Total Hip Arthroplasty With Large Femoral Heads for the Treatment of Displaced Intracapsular Femoral Neck Fractures in the Elderly
试验速览
- 阶段
- 1 期
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Oxford hip score (OHS)
研究概览
简要总结
The purpose of this study is to compare hemiarthroplasty (HAP) with total hip arthroplasty (THA), performed by trained arthroplasty surgeons with the use of large femoral heads for the treatment of displaced femoral neck fractures in mobile independent elderly patients, to determine the impact of these surgical options on the short term functional outcomes and complication rates, namely dislocation and the need for further surgery.
This is a single-blinded prospective randomized clinical trial comparing functional outcome and complication rates of 40 patients treated with all cemented THA to a control group of 40 patients treated with cemented bipolar HAP, in a 2 years followup.
The primary endpoint is the Oxford hip score (OHS) at last followup as a measure of functional outcome. Secondary endpoints include the SF-36 score, walking distance and rates of postoperative dislocation, component loosening, need for revision and postoperative mortality.
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 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acute femoral neck fracture.
- •Age between 70 and 90 years old.
- •Independent community ambulator (more than 0.5km, without the aid of another person. The use of a cane is permitted) prior to fracture.
- •Abbreviated mental test score > 6 .
排除标准
- •Pathological fracture (excluding osteoporosis).
- •Rheumatoid arthritis.
- •Symptomatic arthrosis of the involved hip.
- •Neurological disorder that may significantly influence walking ability and/or tendency to dislocate.
- •Chronic corticosteroid use.
- •Concomitant other fracture.
- •Very high surgical risk.
结局指标
主要结局
Oxford hip score (OHS)
时间窗: last followup - 2 years
次要结局
- SF-36 score, walking distance(2 years followup)
- dislocation rate, mortality rate(within follow up - 2 years)