Undisplaced Femoral Neck Fractures Treated With 2 Hansson Pins Without Plate or 3 Hansson Pins Interlocked in a Plate (Pinloc) - A Randomized Controlled Trial Using Radiostereometry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change in fracture displacement during healing measured with radiostereometry
研究概览
简要总结
Femoral neck fractures represent about half of the hip fractures and are further divided into displaced and undisplaced fractures. Displaced femoral neck fractures are almost always treated surgically with arthroplasty. However there is an ongoing debate on which implant is superior for undisplaced fractures.
A novel implant design (Pinloc) has been developed by Swemac Innovation AB. While the original implant consisted of 2 isolated hook pins, the modified design consists of 3 titanium hook pins interlocked in an aluminum plate. Interlocking is a new principle of implant design and improves fixation and load transfer amongst the pins. The superiority of the modified design is so far only proven preclinically.
The role of the Pinloc in clinical use remains unclear. Investigators are planning a randomized controlled trial on undisplaced femoral neck fractures to establish a method for implanting the tantalum markers, to observe the fracture healing process and to further investigate the role of the Pinloc.
详细描述
Femoral neck fractures represent about half of the hip fractures and are further divided into displaced and undisplaced fractures. Displaced femoral neck fractures are almost always treated surgically with arthroplasty. However there is an ongoing debate on which implant is superior for undisplaced fractures.
A novel implant design (Pinloc) has been developed by Swemac Innovation AB. While the original implant consisted of 2 isolated hook pins, the modified design consists of 3 titanium hook pins interlocked in an aluminum plate. Interlocking is a new principle of implant design and improves fixation and load transfer amongst the pins. The superiority of the modified design is so far only proven preclinically. The role of the Pinloc in clinical use remains unclear.
A series of studies is now planned at Oslo University Hospital in collaboration with Diakonhjemmet Hospital in hope to further clarify this debate. The use of the Pinloc has been introduced in some regions (e.g. Norway, Sweden and Japan). The role of the Pinloc remains unclear and very little has been published on it's use, even though it is believed to be an important contributor of stability to the fixation.
Femoral neck fractures are mainly caused by a fall from own height in the elderly. The fractures are most often classified as displaced or not, using the simplified Garden classification. Several other classification systems also exist, but these have not been shown to be of reliable clinical usefulness. The ideal classification system should be easily applicable, reliable, and aid in treatment decision making and prognosis.
The treatment of femoral neck fractures comprise perioperative and operative modalities. The perioperative modalities consist among others of medical optimalization preoperatively, early rehabilitation and prevention of new fractures by treating osteoporosis and preventing new falls. The main scope of the current study will, however, be the operative modalities.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undisplaced femoral neck fractures
- •able to walk independently, aids such as crutches or walker allowed
- •able to consent
- •fit for surgery with pins with or without plate
排除标准
- •not willing or able to attain follow up
- •previous fracture or surgery with retained metal work in the same hip
- •concomitant disease that will shorten life expectancy (i.e. cancer, COPD)
结局指标
主要结局
Change in fracture displacement during healing measured with radiostereometry
时间窗: Up to 52 weeks
Will be measured by RSA postoperatively, before discharge and after 4, 8, 12, 24 and 52 weeks. Total displacement from first reading to the reading showing maximum displacement is the main outcome.
次要结局
- Reoperation for healing problems(52 weeks)
- Eq5d(4 weeks)
- Change in time to union as measured by RSA (cessation of motion) and radiographs(Will be examined at 4, 12, 26 and 52 weeks)
- Timed Up and Go test(52 weeks)
- Motion during healing as measured by plain radiographs.(Up to 52 weeks)
- Time of surgery(1 week)
- Satisfaction with operated hip (NRS)(52 weeks)
- Motion during healing as measured by radiostereometry.(Up to 52 weeks)
- Mortality(52 weeks)
- Perioperative blood loss(1 week)
- Change in time to union as measured by plain radiographs and clinical findings(Will be examined at 4,12, 26 and 52 weeks)
- Postoperative pain (NRS) while in hospital(1 week)
- Harris Hip Score(Up to 52 weeks)
- Pain (NRS)(52 weeks)
研究者
Frede Frihagen
Consultant, PhD
Oslo University Hospital