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临床试验/NCT00594893
NCT00594893已完成不适用

A Prospective Randomized Trial of Mini Incision and 2-Incision Total Hip Arthroplasty

Rush University Medical Center2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2006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
72
试验地点
2
主要终点
Pain scores

研究概览

简要总结

The purpose of the research is to determine if there is a difference between two of the commonly used less invasive techniques (surgical methods that use a smaller incision or cut in the skin) used to perform total hip arthroplasty (replacement of your painful hip with a new ball and socket). It is unclear which of these techniques is associated with a faster recovery and lower risk of complications.

详细描述

Recently, surgical techniques and surgical instruments have been developed to limit the dissection required to perform a total hip arthroplasty. Proponents of these procedures feel that it is associated with less perioperative blood loss, less pain and an accelerated recovery while critics have raised concerns that the more limited exposure may negatively impact component position and increase the risk of perioperative complications. Among less invasive surgical techniques, two of the different approaches utilized include a "mini-incision" posterior approach which aims to limit the amount of dissection associated with a standard posterior approach to the hip and a 2-incision technique which seeks to further limit soft tissue disruption by taking advantage of intermuscular planes and the use of fluoroscopic guidance.

While the mini-posterior approach utilizes an abbreviated exposure which is familiar to most surgeons, the 2-incision approach is a more novel approach and critics of this approach feel that its technically demanding nature may be associated with a higher risk of complications and component malposition. Proponents of the 2-incision approach feel that this approach is less invasive, more muscle sparing and leads to substantial improvements in patient rehabilitation and recovery with potential longer-term benefits in terms of improved function. The goal of this project is to compare the use of a mini-incision posterior approach and the 2-incision approach in primary total hip arthroplasty via a prospective randomized trial.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
None

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

  • diagnosis of hip osteoarthritis
  • age greater than 18 years
  • willingness to undergo a neuraxial anesthetic for the procedure
  • female patient greater than one year postmenopausal, surgically sterile or using an accepted form of contraception

排除标准

  • use of any medication that may impact platelet aggregation within 10 days of surgery
  • chronic use of coumadin for anticoagulation
  • the use of low molecular weight heparin postoperatively
  • clinically significant systemic disease or laboratory abnormalities
  • a primary hematologic disorder
  • recent gastrointestinal or intracranial bleeding
  • any contraindication to anticoagulant use
  • history of previous ipsilateral hip surgery
  • a body mass index of greater than 30
  • significant hip deformity that precludes the use of standard implants
  • use of ONLY general anesthetic during surgery

结局指标

主要结局

Pain scores

时间窗: Daily for 6 weeks postoperatively

次要结局

  • Functional milestones(daily for 6 weeks postoperatively)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Craig J Delle Valle

MD

Rush University Medical Center

研究点 (2)

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