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临床试验/NCT02959320
NCT02959320已完成不适用

A Randomized Clinical Trial of Direct Anterior vs. Anterolateral Approach for Hip Arthroplasty After Femoral Neck Fracture in the Senior Population

Mayo Clinic2 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
Mayo Clinic
入组人数
69
试验地点
2
主要终点
Number of patients showing improvement using the Timed Up and Go (TUG) Test

研究概览

简要总结

Displaced femoral neck fractures are one group of hip fracture patients that are commonly treated with cemented hemiarthroplasty (HA) or total hip arthroplasty (THA). In the elective hip arthroplasty population, the direct anterior approach (DAA) has shown to be effective in helping patients to quickly obtain high postoperative function. This approach has also been shown to be effective in arthroplasty for displaced femoral neck fractures in a few studies. However, the only studies that directly compare two approaches for hip arthroplasty for femoral neck fractures utilize the anterolateral approach (ALA) versus posterior approach (PA) or DAA versus PA. No studies of which we are aware directly compare the DAA to the ALA. The DAA and ALA are the two most popular approaches for bipolar hemiarthroplasty at our institution, so we are setting out to determine the differences between them.

详细描述

Displaced femoral neck fractures are one group of hip fracture patients that are commonly treated with cemented hemiarthroplasty (HA) or total hip arthroplasty (THA). Compared to those who receive a THA, recipients of HA tend to be less active, more debilitated, and more dependent on gait aids and the care of others. In this population, the increased stability and decreased operating time associated with HA is thought to be more important than the minimal increase in function this population could achieve with THA. Additionally, cemented femoral stems in HA are thought to result in less pain, increased function, and less periprosthetic fracture risk when compared to cementless stems.

With the relative pre-injury debility of the femoral neck fracture population, especially those receiving HA, it is important to optimize all aspects of patient care to allow them to participate in therapy and return them to their preoperative functional level as quickly as possible. Furthermore, any intervention in this population should minimize the physiologic insult of surgery as much as possible. In the elective hip arthroplasty population, the direct anterior approach (DAA) has shown to be effective in helping patients to quickly obtain high postoperative function. This approach has also been shown to be effective in arthroplasty for displaced femoral neck fractures in a few studies. However, the only studies that directly compare two approaches for hip arthroplasty for femoral neck fractures utilize the anterolateral approach (ALA) versus posterior approach (PA) or DAA versus PA. No studies of which we are aware directly compare the DAA to the ALA. The DAA and ALA are the two most popular approaches for bipolar hemiarthroplasty at our institution, so investigators are setting out to determine the differences between them.

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
None

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • isolated displaced femoral neck fracture (AO type 31-B2 and 31 B3)
  • age≥65 years
  • preinjury ambulation with or without a gait aid
  • surgical intervention ≤ 48 hours after fracture.

排除标准

  • age <65 years
  • patients with other fractures or dislocations
  • wheelchair bound
  • >48 hours between fracture and surgery, presence or history of infection, active metastatic disease, previous ipsilateral hip prosthesis
  • active major psychiatric illness
  • active drug or alcohol abuse
  • BMI >40, and actively failing contralateral hip prosthesis.

结局指标

主要结局

Number of patients showing improvement using the Timed Up and Go (TUG) Test

时间窗: Baseline to 12 months

Purpose of test is to assess mobility and will be administered by a nurse who is blinded to the surgical approach.

次要结局

未报告次要终点

研究者

发起方
Mayo Clinic
申办方类型
Other
责任方
Principal Investigator
主要研究者

William W. Cross, III M.D.

Assistant Professor of Orthopedics,

Mayo Clinic

研究点 (2)

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