Intellijoint HIP Limited Release Trial: An Intelligent Instrument for Improved Leg Length and Hip Offset Accuracy in Total Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 入组人数
- 128
- 试验地点
- 2
- 主要终点
- Accuracy of leg length
研究概览
简要总结
Leg length discrepancies following total hip arthroplasty have been associated with nerve palsies, gait abnormalities, and lower back pain. Leg length discrepancies are related to poorer functional outcomes and patient dissatisfaction. Failure to restore femoral offset following total hip arthroplasty has been linked to decreased range of motion and abductor muscle strength, impingement, limping, higher dislocation rates, increased polyethylene wear, and loosening of implants. Computer navigation has shown to improve the accuracy of leg length and hip offset during total hip arthroplasty. The investigators research objective is to prove the accuracy of the Intellijoint HIP™ system for determining leg length and hip offset. The investigators hypothesis was that Intellijoint HIP™, an imageless intraoperative intelligent instrument, could improve the accuracy of leg length and hip offset during primary total hip arthroplasty. The investigators plan to study this hypothesis in humans by comparing the leg length and hip offset discrepancies produced with Intellijoint HIP™ to the standard at the investigators institution, which is a pin and outrigger system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Any patient who is undergoing a primary total hip arthroplasty at Mount Sinai Hospital.
排除标准
- •Pre-operative flexion contracture >30°, infection, or inability to achieve rigid fixation of instruments intra-operatively.
结局指标
主要结局
Accuracy of leg length
时间窗: 6 weeks post-op
Standard post-operative anteroposterior pelvis radiographs will be used to assess the leg length discrepancy
Accuracy of Hip Offset
时间窗: 6 weeks post-op
Standard post-operative anteroposterior pelvis radiographs will be used to assess the hip offset restoration
次要结局
- Time of surgery(Measured at the time of surgery)
- Harris Hip Score(1 year)
- Dislocation Rates(1 Year)
- Oxford Hip Scores(6 weeks and 1 year post-op)
