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临床试验/NCT07409909
NCT07409909已完成不适用

Total Hip Arthroplasty Versus Bipolar Hemiarthroplasty for Treatment of Intracapsular Displaced Fracture Neck Femur in Elderly Active Patients; Single-center Randomized Controlled Trial

Al-Azhar University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2023年1月2日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
functional improvement

研究概览

简要总结

Femoral neck fracture (FNF) is a worldwide health problem that can cause significant morbidity and mortality. Most femoral neck fractures are associated with a fall, and the risk factors include osteoporosis, chronic medication use, and reduced level of activity.

Femoral neck fractures are among the most common injuries in the elderly, and their number continues to increase with a more aged population.

In the elderly, femoral neck fractures may lead to significant mortality and morbidity, with impaired mobility and loss of independence. Given their high incidence and associated detrimental effects on patient lives.

The femoral neck fracture is a major type of hip fracture, whose treatment includes internal fixation, hemiarthroplasty (HA), or total hip arthroplasty (THA). The decision depends on multiple variables, including fracture pattern, surgeon comfort, and the patient's age, health, and ambulatory status. Internal fixation is a preferred management option for young people or the elderly who are intolerant of prosthesis surgery. THA and HA are widely used in displaced femoral neck fractures in the elderly. Surgery in these patients is undertaken to facilitate nursing and provide timely pain relief, rapid mobilization, and accelerated rehabilitation In general, HA has the advantages of shorter operation time, less blood loss, less technical demand, less economic burden, and a lower dislocation rate. However, some patients treated with HA require conversion to THA due to complications such as acetabular erosion.

THA, on the other hand, has been associated with superior patient satisfaction and better hip function, less acetabular erosion, and a lower revision rate. However, increased surgical complexity, operation time, and blood loss, as well as higher dislocation rates in THA for FNFs, remain a concern

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
Single (Investigator)

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • were aged ≥ 65 years
  • with a displaced intracapsular fracture of the femoral neck (Garden type III, IV).

排除标准

  • extracapsular fracture of the femoral neck
  • Pathological fractures, or open fractures
  • Active infections at or near the hip joints.
  • bedridden, immobile, or cognitively impaired patients
  • patients with associated pelvic or acetabular fractures

研究组 & 干预措施

Total Hip Arthroplasty

Experimental

干预措施: Total Hip Arthroplasty (Procedure)

Bipolar Hemiarthroplasty

Active Comparator

干预措施: Bipolar Hemiarthroplasty (Procedure)

结局指标

主要结局

functional improvement

时间窗: 12 months

will be assessed via modified Harris Hip Score. The score is calculated based on four parameters: pain (0-44 points), function (0-47 points), absence of deformity (0-4 points), and range of motion (0-5 points).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mahmoud Ragab Abdel-Aty El-Sayed

Dr

Al-Azhar University

研究点 (1)

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