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临床试验/NCT02897440
NCT02897440Unknown不适用

Full Repairing Versus Partial Repairing of Soft Tissue Surrounding the Hip Joint in Hip Arthroplasty for Femoral Neck Fractures

First Hospitals affiliated to the China PLA General Hospital0 个研究点目标入组 30 人开始时间: 2016年10月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
主要终点
Trendelenburg Test

研究概览

简要总结

A prospective cohort study to compare full repairing and partial repairing of soft tissue surrounding the hip joint in anteriorolateral approaching arthroplasty concerning hip function. Patients admitted with a femoral neck fracture operated with a hip arthroplasty through an anteriorolateral approach were screened for inclusion. Patients with altered mental status SPMSQ <7, pathological fractures, non-walkers were excluded.

详细描述

Those who fulfilled the inclusion criteria and non of the exclusion criteria were followed 2 months postoperatively by clinical examination. Sample size were estimated to 15 patients in each group. Primary outcome variables were trendelenburg test, abductor strength measured with dynamometry. Secondary outcome variables were WOMAC, EQ-5D, and VAS scores.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Displaced femoral neck fracture
  • Hemiarthroplasty or Total Hip Arthroplasty
  • Preiffer test >7/10

排除标准

  • Pathological fracture
  • Non-walker
  • Pfeiffer test <7/10 indicating mental alteration

结局指标

主要结局

Trendelenburg Test

时间窗: At 4 week postoperatively

30 seconds standing on the operated leg

Abductor strength

时间窗: At 4 week postoperatively

Dynamometry

次要结局

  • Pain (Visual analouge scale)(At 2, 4, 6 weeks and 12 months postoperatively)
  • Quality of life (EQ-5D)(At 2, 4, 6 weeks and 12 months postoperatively)
  • WOMAC(At 2, 4, 6 weeks and 12 months postoperatively)

研究者

发起方
First Hospitals affiliated to the China PLA General Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Haibo Lu

Attending Surgeon

First Hospitals affiliated to the China PLA General Hospital

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