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临床试验/NL-OMON35128
NL-OMON35128已完成不适用

Hip Fracture Evaluation with ALternatives of Total Hip Arthroplasty versus Hemi-Arthroplasty (HEALTH): A Multi-Centre Randomized Trial Comparing Total Hip Arthroplasty and Hemi-Arthroplasty on Revision Surgery and Quality of Life in Patients with Displaced Femoral Neck Fractures - HEALTH

Erasmus MC, Universitair Medisch Centrum Rotterdam0 个研究点目标入组 150 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
150

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

年龄范围
18 至 99(—)

入选标准

  • 1. Adult men or women aged 60 years and older (with no upper age limit).
  • 2. Fracture of the femoral neck confirmed with either anteroposterior or lateral hip radiographs.
  • 3. Displaced fracture in the judgment of the attending surgeon.
  • 4. Operative treatment within 3 days (i.e., 72 hours) of presenting to the emergency room.
  • 5. Provision of informed consent by patient or legal guardian.
  • 6. No other major trauma to ipsi- or contralateral extremity.

排除标准

  • 1. Patient not suitable for hemi-arthroplasty (i.e., inflammatory arthritis, rheumatoid arthritis, pathologic fractures, or severe osteoarthritis of the hip).
  • 2. Associated major injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture).
  • 3. Retained hardware around the affected hip.
  • 4. Infection around the hip (soft tissue or bone).
  • 5. Patients with a disorder of bone metabolism other than osteoporosis (i.e., Paget*s disease, renal osteodystrophy, osteomalacia).
  • 6. Moderate or severe cognitively impaired patients (i.e., Six Item Screener with 3 or more errors).
  • 7. Patients with Parkinson*s disease (or dementia) severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation.

研究者

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