Fixation using Alternative Implants for the Treatment of Hip Fracture (FAITH):A Multi-Centre Randomized Trial Comparing Sliding Hip Screws and Cancellous Screws on Revision Surgery Rates and Quality of Life in the Treatment of Femoral Neck Fractures
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 3
- 主要终点
- To assess the impact of sliding hip screws versus cancellous screw fixation on rates of revision surgery at 2 years in individuals with femoral neck fractures
研究概览
简要总结
Hip fractures occur in 280,000 Americans (over 5,000 per week) and 36,000 (over 690 per week) Canadians annually. The number of hip fractures is likely to exceed 500,000 annually in the United States and 88,000 in Canada. The estimated annual health care costs will reach a staggering $9.8 billion in the United States and $650 million in Canada. Hip fractures are associated with a 30% mortality rate and profound temporary and sometimes permanent impairment of independence and quality of life. Worldwide, 4.5 million persons are disabled from hip fractures yearly with an expected increase to 21 million persons living with disability in the next 40 years. Experimental data suggest that cancellous screws offer greater preservation of blood supply, while sliding hip screws provide greater biomechanical stability to bending stresses. While both arguments are persuasive, the impacts of these biologic alterations on outcomes that are important to patients offer more compelling guidance for clinical practice.
Although current opinion among orthopaedic surgeons favour the use of cancellous screws over sliding hip screws, there remains sufficient divergence in perceptions and sufficient interest to resolve this issue to warrant a large randomized controlled trial. Despite the popularity of cancellous screw fixation, there is a strong biologic rationale supporting the sliding hip screws, a more biomechanically stable construct, in older patients with osteopenia or osteoporosis. While our meta-analysis provides indirect and direct evidence that a sliding hip screw may reduce revision surgery rates, the evidence remains far from definitive. The current best estimate of treatment effect with sliding hip screws is based upon small trials with methodological limitations including unconcealed randomization and lack of blinding. The resulting estimates include wide confidence intervals (i.e., displaced fractures: RRR=27%, 95%CI: 48%, -4%, P=0.08). Whatever approach to internal fixation proves best, a large proportion of patients will continue to need revision surgery that is associated with high morbidity and appreciable mortality
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult men or women aged 50 years and older (with no upper age limit).
- •Fracture of the femoral neck confirmed with either anteroposterior and lateral hip radiographs, computed tomography, or magnetic resonance imaging (MRI).
- •Any degree of displacement (i.e., undisplaced or displaced) of the femoral neck fracture that can be closed reduced.
- •Operative treatment of displaced fractures within 2 days (i.e., 48 hours) of presenting to the emergency room.
- •Operative treatment of undisplaced fractures within 7 days of presenting to the emergency room.
- •Patient was ambulatory prior to fracture, though they may have used an aid such as a cane or a walker.
- •Anticipated medical optimalization for operative fixation of the hip.
- •Provision of informed consent by patient or legal guardian.
- •No other major trauma.
排除标准
- •Patients not suitable for internal fixation (i.e., severe osteoarthritis, rheumatoid arthritis, or pathologic fracture).
- •Associated major injuries of the lower extremity (i.e., ipsilateral or contralateral fractures of the foot, ankle, tibia, fibula, knee, or femur; dislocations of the ankle, knee, or hip; or femoral head defects or fracture).
- •Retained hardware around the affected hip.
- •Infection around the hip (i.e., soft tissue or bone).
- •Patients with disorders of bone metabolism except osteoporosis (i.e., Pagets disease, renal osteodystrophy, osteomalacia).
- •Moderate or severe cognitively impaired patients (i.e., Six Item Screener with 3 or more errors).
- •Patients with Parkinsons disease (or dementia) severe enough to increase the likelihood of falling or severe enough to compromise rehabilitation.
- •Likely problems, in the judgment of the investigators, with maintaining follow-up.
- •We will, for example, exclude patients with no fixed address, those who report a plan to move out of town in the next year, or intellectually challenged patients without adequate family support.
结局指标
主要结局
To assess the impact of sliding hip screws versus cancellous screw fixation on rates of revision surgery at 2 years in individuals with femoral neck fractures
时间窗: To assess the impact of sliding hip screws versus cancellous screw fixation on rates of revision surgery at 2 years in individuals with femoral neck fractures
次要结局
- To determine the impact on health-related quality of life,functional outcomes and health outcome(2 years)