Intramedullary Nailing Versus Plate Fixation of Ankle Fractures.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- American Orthopaedic Foot and Ankle Society (AOFAS) score
研究概览
简要总结
The purpose of this study is to make a survey of functional outcome, radiological outcome and complication rate after intramedullary nailing (IMN) and plate fixation of Weber B ankle fractures in elderly patients, and contribute in choosing the best surgical method for these ankle fractures.
详细描述
Open reduction and internal fixation (ORIF) is the gold standard treatment for unstable Weber B fractures, using compression screws and a neutralization plate. In the elderly, pre-existing co-morbidities, osteoporosis and poor skin conditions may give a high complication rate, including wound complications, symptomatic hardware and hardware failure. Due to concerns with complications related to ORIF, the technique with intramedullary fixation has been introduced. This method may simplify the management when poor skin conditions and osteoporotic bone, and has the potential to reduce the risk of soft tissue and hardware complications. Previous studies have showed that intramedullary fixation is probably the best choice for treating unstable ankle fractures in elderly patients, but more studies are needed to conclude the superiority to standard plate fixation.
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
- •Acute unstable Weber B fracture (unimalleolar, bimalleolar or trimalleolar fractures).
- •Operable with both methods of surgery within 3 weeks after injury.
- •Men and women ≥ 60 yoa.
排除标准
- •Prior injury or pathology with reduced ankle function.
- •Other acute foot/ankle/leg injury that will affect ankle function.
- •Fracture of the posterior malleolus that need fixation.
- •Injury / pathology that may affect rehabilitation.
- •Open fracture.
- •Inoperable patient.
- •Dementia (MMSE score ≤ 24 points), reduced competent to consent, not able to express himself/herself in Norwegian or English.
结局指标
主要结局
American Orthopaedic Foot and Ankle Society (AOFAS) score
时间窗: 5 years
Functional outcome as assessed by AOFAS score (0-100)
次要结局
- Olerud and Molander Score (OMS)(5 years)
- Visual analogue scale (VAS)(5 years)
- Infection(3 months)
- Malunion as assessed by CT scans(5 years)
- Nonunion as assessed by CT scans(5 years)
- Manchester-Oxford Foot questionnaire (MOxFQ)(5 years)
- EuroQol-5d (Eq-5d)(5 years)
- Osteoarthritis as assessed by CT scans(5 years)
- Fracture reduction as assessed by CT scans(3 months)
- Delayed wound healing(3 months)
- Other complications(5 years)
研究者
Elisabeth Ellingsen Husebye
Principal investigator
Oslo University Hospital