跳至主要内容
临床试验/NCT00936949
NCT00936949已完成不适用

Posterolateral Surgical Approach Compared With Modified Lateral Approach: A Prospective, Randomised Trial

Seoul National University Bundang Hospital2 个研究点 分布在 1 个国家目标入组 196 人开始时间: 2003年7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
196
试验地点
2
主要终点
to examine the null hypothesis that the dislocation rate for the posterior approach with capsular repair was similar to modified lateral approaches for total hip arthroplasty at up to 2 year followup

研究概览

简要总结

It has been reported that the operative approaches have an effect on clinical outcome in total hip arthroplasty. The purpose of this prospective study was to compare clinical and radiological outcomes between anterolateral approach and posterolateral approach in total hip arthroplasty.

详细描述

Total hip arthroplasty is one of the most successful orthopaedic procedures for relieving pain and improving quality of life. But dislocation remains the leading early complication after total hip arthroplasty with a reported frequency between 0.4% and 11%. There are several risk factors of dislocation after total hip arthroplasty including patients, implants and surgical approaches. Among lots of risk factors, surgical approach has been debated as one of the important key factor influencing dislocation and abductor function. Direct lateral or posterolateral surgical approach is most commonly used in the total hip arthroplasty. The modified lateral approaches generally are thought to have lower dislocation rates and allow excellent acetabular exposure although limping is increased. The posterolateral approach may allow maintenance of abductor strength but it generally results in a higher dislocation rate. However, there are several reports that the posterolateral approach with capsular repair might be reduced dislocation rate.

We hypothesize the dislocation rate for the posterolateral approach with capsular repair is similar to modified lateral approaches for total hip arthroplasty. A prospective, randomized-controlled study was to examine the null hypothesis that the dislocation rate for the posterior approach with capsular repair was similar to modified lateral approaches for total hip arthroplasty at up to 2 year followup. We attempted to determine whether there was a difference in surgical parameters, component positioning, and clinical results of the modified lateral approach compared with the posterolateral approach.

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
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • osteonecrosis
  • primary or secondary osteoarthritis of the hips
  • femoral neck fracture.

排除标准

  • Patients with previous hemi- or total hip arthroplasty
  • highly dislocated or severe ankylosed hip
  • patients who are considered potentially unreliable or who may not reliably attend study visits

结局指标

主要结局

to examine the null hypothesis that the dislocation rate for the posterior approach with capsular repair was similar to modified lateral approaches for total hip arthroplasty at up to 2 year followup

时间窗: up to 2 years

次要结局

  • to determine whether there was a difference in surgical parameters, component positioning, and clinical results of the modified lateral approach compared with the posterolateral approach.(Routine follow-up visits were scheduled for six weeks, three, six, nine, twelve months, and yearly thereafter)

研究者

申办方类型
Other

研究点 (2)

Loading locations...

相似试验