跳至主要内容
临床试验/NCT01344772
NCT01344772已完成不适用

Total Hip Arthroplasty Compared to Internal Fixation for Displaced Intracapsular Fractures of the Femoral Neck. A Randomized, Controlled Trial With a Seventeen Year Follow-up

Danderyd Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 1990年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Harris hip score

研究概览

简要总结

The primary aim of this study was to determine the Harris hip score as an evaluation of hip function, in mentally competent elderly patients (>65 years old) treated with either THR or IF, after contracting a displaced femoral neck fracture. The secondary aim was to compare the rate of reoperations and complications between the two groups.

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
否

入选标准

  • •Acute displaced femoral neck fracture Garden III or IV,
  • •Age over 65 years,
  • •Admission from their own home,
  • •No concurrent joint disease or previous fracture in the lower extremities,
  • •Healthy or controlled medical conditions without significant systemic effects (ASA 1-2),
  • •Harris hip score of 100
  • •Acceptance from the patient to participate in the study.

排除标准

  • 未提供

研究组 & 干预措施

Internal fixation

Active Comparator

Displaced femoral neck fracture treated with internal fixation using two parallel cannulated screws.

干预措施: Internal fixation (Procedure)

Total hip replacement

Active Comparator

Displaced femoral neck fracture treated with total hip replacement through a posterior approach.

干预措施: Total hip arthroplasty (Procedure)

结局指标

主要结局

Harris hip score

时间窗: 17 years

HHS index score of 0 indicates the worst possible function of the hip and a value of 100 indicates full function.

次要结局

  • Reoperations and complications(17 years)

研究者

发起方
Danderyd Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Olof Skoldenberg

Consulatant Orthopaedic Surgeon, PhD

Danderyd Hospital

研究点 (1)

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