Compare Early Weight Bearing as Tolerated (WBAT) Group With Weight Bearing Restriction(WBR) After Hip Fracture Nailing,
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Harris Hip Functional score
研究概览
简要总结
Purpose: Proximal femur fracture is a major traumatic injury in elderly populations; however, practical postoperative weight-bearing protocols are lacking. Therefore, the purpose of the present study was to investigate whether early weight-bearing status after proximal femur nail fixation is associated with any loss of reduction and evaluate the clinical outcomes of this intervention.
Patients and methods:
For this prospective single-center clinical trial study, we recruited 60 geriatric proximal femur fracture cases, classified by AO/OTA 2018, receiving intramedullary nail fixation. The participants were assigned to the Early-weight-bearing group (n= 30) or the Weight-bearing restriction group (n = 30). Clinical outcomes included the Harris functional hip score and VAS pain score. Additionally, demographic data, radiological parameters, time to weight-bearing, mortality rate, medical and surgical complications, and final ambulation status were recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with AO/OTA type 31 fractures were included, and all fractures were classified using intraoperative fluoroscopy with traction on the fracture table.
排除标准
- •Patients with pathological fractures, neurovascular insufficiency, ipsilateral lower extremity musculoskeletal injury, multiple fractures, or high risk of falling, including frequent falling accidents within 6 months, unsteady gait, ipsilateral neuropathy, limb weakness, and urinary incontinence were excluded.
研究组 & 干预措施
Early-Weight bearing
Early Weight bearing was defined as starting Weight bearing within 48 h postoperatively, and WBAT referred to the adjustment of fracture site weight-bearing by pain tolerance.
干预措施: Early-Weight bearing (Behavioral)
Weight-bearing restriction
Weight bearing as toleration started after 48 h postoperatively.
结局指标
主要结局
Harris Hip Functional score
时间窗: Functional and radiographic evaluations was performed at months 12 postoperatively
The questionaire to patient. (HHS score 0-100,\<60 poor,\>80 good)
次要结局
- Visual analog pain score(Record at months 12 postoperatively)
- Complication(Functional and radiographic evaluations were performed at week 1, months 1, 3, 6, and 12 postoperatively)