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