Immediate Weight Bearing as Tolerated Versus Protected Weight Bearing in Supracondylar Distal Femur Fractures; a Prospective, Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Time to Distal Femur Fracture Healing by Radiographic Evidence
研究概览
简要总结
This study is designed to examine if immediate weight bearing on a distal femur fracture fixed with a primary locking plate, either a distal condylar locking plate or a LISS (less invasive stabilization system), is safe and promotes more rapid fracture healing than partial weight bearing, which is standard of care.
详细描述
This study is designed to examine if immediate weight bearing on a distal femur fracture fixed with a primary locking plate, either a distal condylar locking plate or a LISS (less invasive stabilization system), is safe and promotes more rapid fracture healing than partial weight bearing, which is standard of care. Historically and currently patients are kept partial weight bearing after fixation of these fractures for 6-12 weeks until callous formation is observed on radiographs. The hypothesis is that participants allowed to bear weight immediately will heal at least as quickly as those who have weight bearing status protected with the added benefits from early mobilization. Fracture healing will be monitored closely by follow up appointments and complications will be documented.
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
盲法说明
Both investigators and participants are aware of the assignment. There is no masking; only randomization.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged > 18 yo
- •distal supracondylar femur fracture (Supracondylar distal femur fractures treated with a locked plate, either a distal condylar locking plate or a LISS (less invasive stabilization system), including peri-prosthetic fractures)
- •both male and female
排除标准
- •Patients with an intracondylar split,
- •polytrauma patients with associated trauma that will inhibit their ability to weight bear,
- •metastatic disease,
- •incomplete follow up,
- •subjects with questionable ability to bear weight (ie advanced dementia),
- •open fractures with bone loss.
结局指标
主要结局
Time to Distal Femur Fracture Healing by Radiographic Evidence
时间窗: up to 12 weeks
Radiographs were analyzed postoperatively to determine bridging of 3 or 4 cortices per standard of care during follow-up office visits.
次要结局
- Time of Participation in Physical Therapy(up to 1 year)
- Time to Ambulation(up to 24 weeks)
研究者
David Hubbard, MD
MD, Chief, Orthopaedic Trauma Service, Professor
West Virginia University