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临床试验/NCT00761813
NCT00761813已完成不适用

Fixation Using Alternative Implants for the Treatment of Hip Fractures: A Multi-Centre Randomized Trial Comparing Sliding Hip Screws and Cancellous Screws on Revision Surgery Rates and Quality of Life in the Treatment of Femoral Neck Fractures

University of Minnesota64 个研究点 分布在 1 个国家目标入组 1,108 人开始时间: 2009年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,108
试验地点
64
主要终点
Revision Surgery

研究概览

简要总结

Each year, hip fracture, an injury that can impair independence and quality of life, occurs in about 280,000 Americans and 36,000 Canadians. The annual healthcare costs associated with this injury are expected to soon reach $9.8 billion in the United States and $650 million in Canada. It is important to have in place optimal practice guidelines for the surgical handling of this injury. One type of hip fracture, called a femoral neck fracture, is often treated with a surgical procedure called internal fixation. When performing internal fixation, most orthopaedic surgeons favor using multiple small diameter screws over using a single large diameter screw with a sliding plate. However, use of the sliding hip screw might in fact result in fewer complications after surgery and reduce the need for a second surgery, called a revision surgery. This study will compare the two different surgical procedures to determine which one results in better outcomes after surgery.

详细描述

One type of hip fracture, called a femoral neck fracture, involves a break in the narrow part of the femur bone where the head of the femur is joined to the main shaft. The break can be either undisplaced, which involves very little separation at the fracture site, or displaced, in which there is substantial separation. Surgeons agree that the best surgical procedure for an undisplaced fracture is internal fixation, in which a mechanical implant reconnects the two separated segments of bone. For displaced fractures, surgeons usually choose between internal fixation and a hip joint replacement.

There is more than one way to perform internal fixation. The majority of orthopaedic surgeons currently favor the use of multiple small diameter cancellous screws. However, an alternative method that uses a single large diameter screw attached to a sideplate, called a sliding hip screw, has been gaining popularity and might reduce post-surgical complications and the need for revision surgery. Which surgical method is best for the patient is unknown. This study will compare the use of multiple small diameter cancellous screws versus a single sliding hip screw on rates of revision surgery 2 years after patients sustain femoral neck fractures and undergo internal fixation. The study will also compare the impact of the two different surgical procedures on the overall health, function, and quality of life of patients. Results from this study may impact current orthopaedic practice.

Participation in this study will last 2 years. Before surgery, participants will complete a baseline assessment that will include x-rays, a medical history review, and a physical examination. Participants will then be randomly assigned to undergo one of two types of internal fixation surgeries for repairing their hip fractures. In one group of participants, surgeons will use at least two small cancellous threaded screws that have a diameter of at least 6.5 mm. In the other group of participants, surgeons will use a single large diameter screw that is partially threaded. This screw, called a sliding hip screw, will be affixed to the femur bone with a sideplate, and there will be no other fixations. All surgeons, who will need to meet certain criteria to partake in the study, will follow the manufacturers' technique guidelines for using either type of screw. Specific aspects of both the pre-operative and post-operative care, such as the use of antibiotics and calcium supplementation, will be standardized for all participants.

Follow-up assessments will be completed either by phone or in-person at the hospital or clinic. They will occur 1, 2, and 10 weeks after surgery and 6, 9, 12, 18, and 24 months after surgery. All assessments will include questionnaires and interviews on health status, hip function, pain, and revision surgery. Some of the in-person assessments will also include x-rays.

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 (Outcomes Assessor)

入排标准

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

入选标准

  • Fracture of femoral neck
  • Operative treatment within 4 days for displaced fractures
  • Operative treatment within 7 days for nondisplaced fractures
  • Ambulatory before the injury
  • Low energy trauma, such as falls from a sitting or standing position
  • No other major trauma

排除标准

  • Unsuited for both surgical treatments
  • Associated major injuries of the lower extremities
  • Retained hardware around the hip
  • Infection around the hip
  • Bone metabolic disorder (except for osteoporosis)
  • Moderate or severe cognitive impairment
  • Parkinson's disease or dementia
  • Unable to complete the 2-year follow-up

研究组 & 干预措施

Multiple Cancellous Screws

Experimental

干预措施: ORIF with multiple cancellous screws (Device)

Single Sliding Hip Screw

Experimental

干预措施: Open reduction internal fixation (ORIF) with single sliding hip screw (Device)

结局指标

主要结局

Revision Surgery

时间窗: Measured 2 years after original surgery

Additional Surgery on the affected hip

次要结局

  • Complications, Including Avascular Necrosis, Nonunion, and Infection(Measured 2 years after original surgery)
  • Quality of Life(Measured 2 years after original surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (64)

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