Two-Hole Versus Four-Hole Dynamic Hip Screw (DHS) for the Treatment of Intertrochanteric Fractures: A Prospective Randomized Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Mechanical failure of fixation (up to 6 months)
研究概览
简要总结
Although Standard of Care for Hip Fractures is the Device (Dynamic Hip Screw) being studied in this project, and both sizes (the 2 and the 4 hole versions) are currently in use there is not widespread agreement yet whether there is an optimal number of screws (2 or 4) required for the best outcomes. If it can be shown that a 2 hole version is just as successful in outcomes it would allow for a smaller incision (surgical cut) at the site of the fracture. This could reduce soft tissue dissection, operating time, and surgical blood loss. This in turn would reduce post operative pain, blood loss, and hospital length of stay.
详细描述
This study has been designed to prospectively evaluate the clinical results of a two-hole versus four-hole dynamic hip screw in the treatment of intertrochanteric fractures.
It is estimated that over 27,000 hip fractures occur in Canada each year, at an estimated cost of $10,000 per patient per hospitalization. Intertrochanteric hip fractures account for approximately half of all hip fractures. While many surgical treatment options exist, the accepted standard fixation device for the treatment of both stable and unstable intertrochanteric hip fractures is the dynamic hip screw.
No consensus exists regarding the optimal number of screws required for adequate side plate fixation for the treatment of intertrochanteric fractures. The most commonly used device is the 135-degree four-hole side plate, however, decreasing the length of the side plate would theoretically allow for a smaller incision site, minimal soft-tissue dissection, shortened operating time, and reduced operative blood loss. This in turn would reduce post-operative pain, blood loss, and length of hospital stay. With the majority of hip fractures occurring in the frail, elderly population, a less invasive procedure potentially decreases overall patient mortality.
Biomechanical studies simulating stable and unstable intertrochanteric fractures have suggested that fewer screws are adequate for good side plate fixation. Two clinical trials have reviewed series of fractures treated with a two-hole DHS and have reported favorable results. No prospective randomized study to date, however, has directly compared the clinical results of the standard four-hole plate with that of the two-hole plate. We propose a study is to evaluate the clinical results of the two-hole versus four-hole plate for the treatment of intertrochanteric fractures with a minimum 6-month follow-up.
This study's aim is to develop clinical outcome data which can be used (a) determine range of expected clinical outcomes resulting from current standard management of these injuries, and (b) as the basis of reporting on the clinical outcomes of these injuries in the peer-reviewed literature.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consenting patients over the age of 65 with an isolated 2-, 3-, and 4-part intertrochanteric hip fractures will be included in this study.
排除标准
- 未提供
结局指标
主要结局
Mechanical failure of fixation (up to 6 months)
次要结局
- Length of incision, post-operative pain, analgesic use, operative time, and mean hemoglobin drop. Length of hospital stay and medical complications will also be assessed while hospitalized