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临床试验/NCT00261040
NCT00261040已完成不适用

Minimally Invasive Surgery of the Hip: A Randomized Study

Ottawa Hospital Research Institute0 个研究点目标入组 40 人开始时间: 2003年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
40
主要终点
Clinical Outcomes

研究概览

简要总结

The purpose of this study is to determine if there is a difference in terms of length of hospital stay and post-operative outcomes between patients whose total hip replacement surgery is performed with a minimally invasive versus standard surgical approach.

详细描述

Traditional techniques for total hip arthroplasty (THA) require complete visualization of the acetabulum and proximal femur since anatomic landmarks are crucial for correct orientation of the prosthetic components. All surgeons are taught that a wide surgical exposure is one of the most important factors in performing successful THA. Traditionally, it was impossible to achieve accurate fixation and orientation of the components without complete visualization of bony landmarks. These extensile exposures facilitate accurate implant alignment, but at the expense of more extensive soft tissue dissection. Little clinical research has been undertaken to relate the surgical approach to postoperative complications or patient function. Furthermore, despite the good overall results of THA, the recovery time to improved function can be lengthy. Blood loss is expected to be directly related to the extent of the surgical exposure and to influence patients outcomes. Based upon these facts, an important principle of arthroplasty surgery is to minimize the amount of soft tissue trauma while being able to achieve the surgical goal of reconstructing the arthritic hip joint. By definition, minimally invasive surgical (MIS) procedures result in less soft tissue disruption, which in turn should reduce pain, expedite healing, decrease recovery time, and potentially reduce the number of associated complications.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

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

  • BMI > 30 kg/m2 No prior ipsilateral hip surgery Osteoarthritis

排除标准

  • Patients with grossly distorted bony anatomy whereby standard implants are contraindicated; i.e. congenital dysplasia of the hip, proximal femoral abnormalities, etc
  • Rheumatoid Arthritis

结局指标

主要结局

Clinical Outcomes

时间窗: 24 months

Hospital length of stay

次要结局

  • Operating Time Duration(Day of Surgery)
  • Harris Hip Score(24 months)
  • Estimated Blood Loss(Day of surgery)
  • Change in Timed Get-up-and-Go Test (TUG)(3 months)

研究者

申办方类型
Other
责任方
Sponsor

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