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临床试验/NCT02095093
NCT02095093Unknown不适用

Intellijoint HIP Limited Release Trial: An Intelligent Instrument for Improved Leg Length and Hip Offset Accuracy in Total Hip Arthroplasty

Mount Sinai Hospital, Canada2 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2014年3月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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