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临床试验/NCT00471913
NCT00471913已完成不适用

Functional Outcome and MR Imaging of Abductor Damage Following Antegrade Femoral Nailing With Different Entry Points: A Prospective Randomized Trial

University of British Columbia1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2007年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
12 month functional outcome and determination of muscle and tendon damage with MR Imaging

研究概览

简要总结

Study focus is femoral shaft (thigh bone) fractures (break) that require surgical treatment under anaesthetic to stabilize the femur fracture. This is usually done by placing a metal nail and screws inside the femur (thigh) bone.

This study has been designed to allow us to learn more about the effect of using a different starting point to insert the nail into the body in order to access the fracture and fix it. This question is important because to date, all entry points currently used do result in some muscle damage. In order to minimize this damage a lateral (side) entry nail has been developed and is currently in use at many centres. This nail is new but, the lateral entry technique for these types of fractures has been used extensively in the past, and this nail has been developed in order to better accommodate the technique.

It is believed that entering laterally instead of going deeper into the tissue to access the bone to fix it is going to result in less muscle damage which in turn will improve functional outcome.

详细描述

Background:

This study has been designed to prospectively evaluate functional outcome and MR imaging of abductor damage following antegrade femoral nailing with different entry points

Recent developments in IM nailing of the femur have favoured the use of the greater trochanter as an entry site as opposed to using the "classical" piriformis fossa. With either technique, a persistent problem appears however to be the damage caused to muscle tissue during preparation of the femur and insertion of the nail. The recent development of femoral nails with an entry point lateral to both these sites offers the potential advantage of avoiding abductor muscle damage.

In several cadaver studies, authors state that a trochanteric entry point causes more damage than a piriformis entry, and that an even more lateral entry point causes even less damage to the abductor muscles compared to the classical piriformis fossa entry site. There is however, no prospective clinical study has specifically evaluated the condition of the abductor tendon and the amount of muscle damage after antegrade nailing in the treatment of femoral shaft fractures. The few clinical studies that have attempted to examine the functional outcome in patients undergoing IM nailing of femoral fractures have used general measurement tools (general functional clinical assessment, gross evaluation of gait) which do not reflect the state of the art at this time and which do not specifically assess gluteal muscle condition. To date, no published study has evaluated the integrity of the gluteus tendon, the damage to the surrounding tissues, and the functional outcome using validated scores. Moreover, no study has compared the "traditional" entry points to a lateral entry nail with this level of precision.

The standard of care for the treatment of femoral shaft fractures is the insertion of an intramedullary nail through the piriformis fossa. Following insertion of femoral IM nails, a number of studies have demonstrated excellent clinical and radiographic results with relatively few complications such as nonunion, malunion, or infection. Intraoperative difficulties with respect to rapid identification of the appropriate starting point have prompted the development of nails that use the greater trochanter as an entry site as opposed to using the "classical" piriformis fossa.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
19 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 19 to 60 years of age
  • Isolated closed femoral shaft fracture
  • Ability to take part in follow-up and functional testing

排除标准

  • Patients under 19 and over 60 years of age
  • Non - traumatic/pathological fractures
  • Ipsilateral acetabulum/pelvis fracture
  • Open femoral shaft fracture
  • Previous lower extremity surgery
  • Pre-existing disability
  • Presents for revision surgery
  • Mentally incompetent to consent

结局指标

主要结局

12 month functional outcome and determination of muscle and tendon damage with MR Imaging

时间窗: 12 months

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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