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临床试验/NCT02085707
NCT02085707已完成不适用

Complications and Functional Outcome of Displaced Femoral Neck Fractures Treated With Internal Fixation vs Total Hip Arthroplasty in Patients Younger Than 70 Years. A Randomized Controlled Double Blind Multi Center Trial.

University Hospital, Akershus8 个研究点 分布在 1 个国家目标入组 118 人开始时间: 2013年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
118
试验地点
8
主要终点
Harris Hip score

研究概览

简要总结

Patients younger than 70 years with a displaced femoral neck are in serious conditions. The femoral neck fracture is associated with low activity levels, hip pain and substantially reduced quality of life. Relatively young individuals with low-energy fractures tend to have additional morbidity or lower bone quality. The literature indicates that 5 % of all displaced femoral neck fractures are in patients aged 55 - 70 years. Little research and lack of consensus and guidance about appropriate treatment of these patients renders choice of treatment, and the health economic aspect a great challenge. In this study the investigators aim to answer if patients aged 55 - 70 years with displaced and low-energy femoral neck fractures treated with a total hip arthroplasty leads to a better functional outcome than osteosynthesis, and can patient-related factors be identified that predispose for femoral fracture? It is a randomized multi center study of patients operated with either total hip arthroplasty or osteosynthesis in which functional outcome, complications and reoperations are compared for the 2 groups. Additional controls are done after 4 and 12 months; 2 and possibly after 3, 5, 10, 15 and 20 years. Map patient - related factors that predispose for displaced femoral neck fractures for patients aged 55 - 70 years. Map bone density measured with Dexa for two types of surgical procedures. Map complications and functional outcome after osteosynthesis or total hip replacement in patients aged 55 - 70 years with displaced femoral neck fractures.

详细描述

Introduction:

Patients younger than 70 years with a displaced femoral neck are in serious conditions. The FNF (femoral neck fracture) is associated with low activity levels, hip pain and substantially reduced QoL (quality of life) . Individuals with high-energy fractures, caused by e.g. car accidents or falls from great heights, are in general healthy and often have normal bone quality in the femoral neck. In these cases, FNF rarely affects the femoral neck but rather the trochanteric area or the femoral shaft. Relatively young individuals with low-energy fractures tend to have additional morbidity or lower bone quality. The literature indicates that 5 % of all displaced FNFs are in patients aged 55 - 70 years. 3535 patients aged 55 - 70 years were registered in the Norwegian Arthroplasty Registry and in the Norwegian Hip Fracture Registry in the period 2005 - 2012. Little research and lack of consensus and guidance about appropriate treatment of these patients renders choice of treatment and the health economic aspect a great challenge. In this study we aim to answer if patients aged 55 - 70 years with displaced and low-energy FNF treated with a THA (total hip arthroplasty) leads to a better functional outcome than osteosynthesis (stabilization by use of hip pins) and can patient-related factors be identified that predispose for FNF?

Background:

Displaced low - energy FNF in patients aged 55 - 70 years is usually treated with internal fixation or implantation of a prosthesis. For patients older than 70 years, several randomized studies compare THA with other treatment options [1,2,3,4,5]; the studies have not found a higher mortality or morbidity for THA. Most orthopedics would probably recommend a closed reposition and osteosynthesis for patients younger than 60 years [6]. Screw fixation procedures will often be of shorter duration and less invasive, but the risk of needing a new operation because of a failure is higher than with prosthetic surgery. With a reoperation the risk of complications is higher than with the first operation. How this affects mortality, morbidity and functional outcome in this patient group is uncertain. Studies have shown both lower morbidity and earlier mortality than with prosthetic surgery [7,8,9]. On the other hand the reoperation rate because of failed osteosynthesis is 28 - 42% versus about 10% for THA; more recent studies show a reoperation rate for THA of 5% [1,2,3,4,5,10]. This is both of clinical and social economic importance. A study by McKinley and Robinson (2002) concluded that THA after failed osteosynthesis (screw fixation) was associated with a significantly higher prevalence of certain complications than THA as a first intervention [11]. Frihagen and collaborators reported about twice as many complications with prosthetic surgery after failed osteosynthesis (screw fixation) than with prosthetic surgery as the first intervention [12]. Young patients with low - energy FNF often have other diseases and conditions that may increase the risk of failed osteosynthesis. Reasons may be use of medication (steroids, epilepsy medication), alcoholism or other types of substance abuse and presence of risk factors for osteoporosis [13]. Several review articles and meta - analyses conclude that THA is associated with a lower rate of complications and a better functional outcome than other treatment alternatives [7,9,14,15]. Most orthopedic departments in Norway treat displaced FNFs in patients under 70 years of age with closed reduction and osteosynthesis or with different types of prosthetic surgery. Osteosynthesis is usually done with fluoroscopy on a transparent lighted stretch table and with some type of cannulated screws (Hip pins). Hemiprostheses or total hip prostheses are used for joint replacement surgery.

Goals for the project:

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
Double (Participant, Care Provider)

入排标准

年龄范围
55 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with displaced femoral neck fractures Garden 3 or 4
  • Age between 55 - 70 years
  • Able to walk before injury

排除标准

  • Refusal to participate.
  • Pathological fractures for other reasons than osteoporosis.
  • Senility or dementia or lack of competence to give informed consent to participate
  • Fracture on the opposite side at the same time
  • Expected life duration less than 12 months and American Society of Anesthesiologists (ASA) 4 + 5
  • Amputated leg
  • Serious neurological disease that renders THA unsuitable
  • Substance narcotic abuse
  • Previous inclusion in the present study

结局指标

主要结局

Harris Hip score

时间窗: 12 months

次要结局

  • VAS(4 and 12 months, 2 years)
  • Harris Hip Score(4 months and 2 years)
  • QoL questionnaire (EQ-5D)(4 and 12 months, 2 years)
  • Complications(4 and 12 months, 2 years)
  • Morbidity(4 and 12 months, 2 years)
  • Bonedensity(Baseline)
  • Reoperation(4 and 12 months, 2 years)
  • Mortality(4 and 12 months, 2 years)
  • Hip dysfunction and Osteoarthritis Outcome Score (HOOS)(4 and 12 months, 2 years)
  • Charlson comorbidity index(4 and 12 months, 2 years)

研究者

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

Stefan Bartels

MD Senior Consultant

University Hospital, Akershus

研究点 (8)

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