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临床试验/NCT06199739
NCT06199739已完成不适用

Safety of Immediate Weight-Bearing as Tolerated After Well-Reduced Geriatric Hip Fracture

Far Eastern Memorial Hospital2 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
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 14 proximal femur fracture cases, classified by AO/OTA 2018, receiving intramedullary nail fixation. 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
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

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.

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 months 1, 3, 6, and 12 postoperatively)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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