short versus long proximal femoral nails in unstable intertrochanteric femur fractures: a comparision of postoperative 30- day mortality, associated factors and functional outcomes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- To compare outcomes associated with short and long proximal femur nail anti-rotation in the treatment of unstable inter-trochanteric femur fractures in the elderly and assess factors impacting them.
研究概览
简要总结
Osteoporotic hip fractures in elderly populations are a growing concern worldwide with increasing life expectancy and growing elderly population; these fractures include fractures of the neck of femur and femoral head, intertrochanteric and subtrochanteric femur fractures. Gullberg et al.in 1997 estimated that the incidence of hip fractures worldwide could be upto 2.6 million by the year 2025 and 4.5 million by the year 2050.
The intertrochanteric region of femur is located between the greater and lesser trochanters and is composed of dense trabecular bone; these fractures are extracapsular fractures of the proximal femur between the trochanters. These fractures have bimodal age distribution with both the young and the elderly affected; however on one hand high energy trauma is the mode of injury in the young, in the elderly population low energy trivial trauma compounded by osteoporosis is the associated mechanism. Patients most commonly present with a history of pain and inability to ambulate after a fall or other injury. The pain is located at the proximal thigh and is exacerbated by passive or active attempts of hip flexion or rotation. The physical findings are shortening and external rotation of the extremity.
As far as the nail designs go, both short and long lengths of the nail are available and there are different types of proximal locks like double screws, spiral blade and single compression screw configurations.
Long nails are available with lengths from 260 to 460 mm and short nails from 180 to 200 mm. Long nails potentially avoid stress concentration near the distal end, reducing chances of secondary fractures of the shaft. However, recent studies suggest similar results and deem short nails as safe in terms of failure and re-fractures with added advantage of shorter operative time and lesser blood loss compared to long nails.Surgeries with short nails are faster owing to no requirement of reaming and distal locking can be done with zig itself without need of patient positioning and C-arm. Without reaming, there is additional benefit of lesser chances of intra-operative fat embolism, which can have a critical impact on patient survival post operatively.
However, with the limited number of randomized trials on the comparison, the superiority of one design over the other has been a matter of debate. Several studies have reported positive outcomes with both short and long PFNs for intertrochanteric femur fractures; however, conflicting issues remain regarding the superiority of 1over the other. This present study is conceptualised to address this specific question in terms of intra operative parameters like surgical duration, blood loss, surgical APGAR score; post operative parameters like blood transfusions, Confusion Assessment Method (CAM) score, duration of hospital stay, union rates, re-fractures, functional outcomes (MHHS) and 30 day and 90 day mortality rates. Furthermore, preoperative and intra operative factors will be correlated with the post operative outcomes.
In the elderly these fractures present a complex scenario because of co-existent one or multiple co-morbidities and overall frailty; they optimally require early surgery and immediate mobilization to minimize the complications associated with recumbency like decubitus ulcers, decreased cardiopulmonary reserves and thromboembolic events, which could be devastating for these old age patients.
The IT femur fractures are either stable or unstable with the latter described as fractures with either loss of the medialcalcar, or comminuted lateral wall; reverse oblique configuration of the fracture line also makes the fractures unstable. In terms of implant of choice for internal fixation, the adequacy of dynamic hip screw which has been in vogue for stable fractures, is relatively inferior in the unstable intertrochanteric femur fracture, in comparison to proximal femoral nails. In terms of surgical options for the unstable variety, the choice ranges from internal fixation with proximal femoral nails to hip replacements surgeries; the former has been shown to be superior in respect of ambulation and mortality rates.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 50.00 Year(s) 至 80.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Cases of isolated unstable intertrochanteric femur fractures 2.Age more than 50 years 3.Trivial trauma 4.Surgery within 72 hours of injury.
排除标准
- •Stable fractures
- •Pathological fractures
- •High energy trauma or polytrauma
- •Immunocompromised patients
- •Local infection
- •Acute MI and Stroke within 1 month
- •Hemiplegic
- •Patient height Less than 5 feet
- •Refuses participation.
结局指标
主要结局
To compare outcomes associated with short and long proximal femur nail anti-rotation in the treatment of unstable inter-trochanteric femur fractures in the elderly and assess factors impacting them.
时间窗: 30 days
次要结局
- A. Duration of surgery: measured from skin incision to closure(B. Measurement of surgical APGAR score intraoperatively)
研究者
Dr Prasoon Kumar
PGIMER, Chandigarh
