Immediate Mobilization After Plate Osteosynthesis of Proximal Tibial Fractures - A Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Loss of reduction
研究概览
简要总结
The purpose of this study is to investigate if immediate mobilization with weight bearing as tolerated following surgery with plates and screws after a fracture of the shinbone near the knee is possible without increased risk.
The investigators hypothesize immediate weight bearing as tolerated following surgery with plates and screws of the above mentioned fracture, in cases deemed stable by the surgeon, will not lead to any loss of reduction.
详细描述
The purpose of this study is to investigate immediate mobilization with weight bearing as tolerated following plate osteosynthesis after a proximal tibial plateau fracture is possible without increased risk of loss of reduction and/or failure of the osteosynthesis. Subsequently, this may lead to earlier recovery and less risk of thromboembolic complications.
The investigators hypothesize immediate weight bearing as tolerated (WBAT) following plate osteosynthesis after a proximal tibial plateau fracture, in cases deemed stable by the surgeon, will not lead to any loss of reduction.
Exposure will be defined as surgery with one or two angular stable plates (closed reduction, internal fixation) after a proximal tibial fracture. Patients will be allowed immediate weight bearing as tolerated in cases where the osteosynthesis is deemed stable. This represents the current practice at Slagelse Hospital. Typical, all lateral tibia plateau fractures (AO fracture classification 41B1-3) osteosynthesized will be allowed immediate WBAT after surgery. Other tibia plateau fractures will be allowed immediate WBAT if the osteosynthesis is deemed stable by the surgeon perioperatively.
Fractures are treated with one or several locking plates, and if needed after reduction of the tibial plateau, an impacted allogenic bone graft is used. The bone graft is applied through a cortical window osteotomy distal to the fracture.
Follow up will be performed at 2 weeks, 6 weeks, 3 months, 6 months and 1 year by any of the authors or a consultant in orthopedics. Follow up will be performed at the outpatient clinic.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient hospitalized and osteosynthesized with one or several locking plates because of a proximal tibial fracture
排除标准
- •Non-ambulatory patients,
- •Patients diagnosed with dementia and
- •Patients residing to another hospital
结局指标
主要结局
Loss of reduction
时间窗: Day 0 to one year after surgery.
Loss of reduction/fracture collapse after ambulation measured by x ray
次要结局
- Status of reoperation(Day 0 to one year after surgery.)
- Knee injury and Osteoarthritis Outcome Score (KOOS)(Day 0 to one year after surgery.)
- Performance Measures(Day 0 to one year after surgery.)
- Wound rupture(Day 0 to 6 weeks after)
- The University of California at Los Angeles (UCLA) Activity Score(Day 0 to one year after surgery.)
- Symptomatic deep venous thrombosis (DVT)(Day 0 to 6 weeks after)
- Length of Hospital Stay(Day 0 to one year after surgery.)
- Return to Work(Day 0 to one year after surgery.)
- Euroqol 5 Dimension (EQ-5D)(Day 0 to one year after surgery.)
- Radiographic Osteoarthritis(Day 0 to one year after surgery.)
- Status of surgery for acute compartment syndrome(Day 0 to 2 weeks after)
- Infection(Day 0 to one year after surgery.)
研究者
Eske Brand
Doctor
Slagelse Hospital