Extramedullary vs. Intramedullary Devices in the Treatment of Unstable Intertrochanteric Hip Fractures
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Fracture classification: Mueller/ AO, displacement, time to union, heterotopic ossification and shortening.
研究概览
简要总结
The purpose of this study is to compare the clinical and radiological outcome of patients that are treated with two different orthopedic implants. The study population will consist of patients that have sustained unstable hip fractures. The two different implants will be randomly assigned.
The null hypothesis states that there should not be any significant differences between the two implants.
详细描述
Intertrochanteric hip fractures are common injuries in the elderly population. They often signify generalized physical deterioration. Operative management has become the standard of care to prevent life threatening complications and dates back to the 1940's. The design of implants has evolved significantly since then.
The sliding hip screw replaced static fixation of the femoral head in the 1950's. As a result of this improvement in design, failures have been reduced to 9-16%. The sliding hip screw allows for stable collapse of the femoral neck. This can lead to significant shortening of the proximal femur in comminuted fractures.
Current treatment modalities focus on obtaining a satisfactory union of the fracture, often at the expense of anatomical alignment. Severely comminuted fractures treated with a standard plate-hip-screw device thus commonly result in significant degrees of mal-union and shortening. In the past, implants designed to restore and maintain the anatomy of the hip have resulted in high failure rates with the implant breaking out of the femoral head. In the mid 1980's, recognition of this led to the development of various intramedullary devices for fixation of these fractures. The weight-bearing portion of the implant is therefore shifted medially, resulting in reduced lever forces on the implant and femur. Additionally, the IM device does not rely on fixation to the lateral cortex of the femur with screws. From a biomechanical standpoint, the intramedullary device has distinct advantages, as it is a load- sharing device more closely located to the axis of weight bearing than the plate-hip-screw device.
Advances in intramedullary designs have been promising, but the clinical results variable. The relatively high rate of fracture at the tip, specifically at the level of the locking bolts, has hampered the widespread popularity of intramedullary devices. Additionally, the large diameter of the proximal aspect of the implants required extensive reaming of the greater trochanter and partial detachment of the gluteus medius. This may lead to abductor weakness and a Trendelenburg gait. Some studies have found increased re-operation rates for these early hip-nail devices compared to the plate -hip-screw implant. Other studies have shown decreased blood loss and operative time with the nails. A meta-analysis of the literature favors the sliding hip screw design. Unfortunately, most studies focus on radiological failure rate rather than patient function and relate to the first generation of IM devices.
The newest generation of nails (like the IM studied here) has attempted to correct the shortcomings of earlier designs. The proximal aspect of the nail diameter is minimized. The distal locking screw is located far away from the distal end of the nail and the locking bolt is placed in an oblique fashion. Design alterations to the femoral head fixation portion of the nail by using a helical blade rather than a screw may improve fixation in the femoral head. These new designs seem to compare favorably in recent clinical tests. Early mobilization for patients with the intramedullary device (IM) seems to be better.
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
- None
入排标准
- 年龄范围
- 55 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •55 years or older
- •Type A2 Intertrochanteric fractures
- •Mono trauma
- •Medically fit for surgery
- •Less than 2 weeks post fracture
排除标准
- •Fractures due to malignancy
- •Non-ambulatory pre-fracture
- •Severe dementia
- •Limited life expectancy due to significant medical co-morbidities
- •Medical contraindication to surgery
- •Inability to comply with rehabilitation of form completion
结局指标
主要结局
Fracture classification: Mueller/ AO, displacement, time to union, heterotopic ossification and shortening.
时间窗: 6 weeks, 3 months, 6 months and 12 months
Timed 2 minute walking distance
时间窗: 6 weeks, 3 months, 6 months and 12 months
TUG (Time up and go) test
时间窗: 6 weeks, 3 months, 6 months and 12 months
Trendelenburg's test: pelvic drop
时间窗: 6 weeks, 3 months, 6 months and 12 months
FIM (Functional Independence Measure)
时间窗: 6weks, 3months, 6months and 12months
LEM (Lower Extremity Measure)
时间窗: 6weeks, 3months, 6months and 12 months
次要结局
- Pre and Post operative Hgb(6 weeks, 3 months, 6 months and 12 months)
- Length of surgery and hospital stay(6 weeks, 3 months, 6 months and 12 months)
- Weight bearing status post-op(6 weeks, 3 months, 6 months and 12 months)
- Complications/ Re-operation(6 weeks, 3 months, 6 months and 12 months)
- Secondary Outcome Variable: Transfusions(6 weeks, 3 months, 6 months and 12 months)
研究者
Rudy Reindl
MD FRCSC
McGill University Health Centre/Research Institute of the McGill University Health Centre
