A Single Center Prospective Controlled Study of Direct Anterior Approach and Posterior Lateral Approach in the Treatment of Femoral Neck Fractures in Elderly Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Harris hip joint function score
研究概览
简要总结
A prospective controlled study was conducted to include patients who received hip replacement surgery for femoral neck fractures at the National Regional Trauma Center in Fujian Province from February 2023 to August 2024. Patients were randomly divided into the DAA group and the PLA group based on different surgical methods for a 3-month follow-up to compare the outcomes of the two groups. The main observation results include Harris hip joint function score (preoperative, postoperative 1 week, 1 month, 3 months), VAS pain score (preoperative, postoperative 1 week, 1 month, 3 months), and secondary observation results include surgical time, intraoperative blood loss, blood transfusion rate, difference in HB before and after surgery, difference in CK before and after surgery, perioperative complications, difference in length of both lower limbs after surgery, postoperative drainage volume, postoperative ICU occupancy rate, ICU length of stay, and total length of stay.
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
入排标准
- 年龄范围
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 80 years old;
- •Diagnosed with unilateral femoral neck fracture through imaging examination;
- •Patients who can tolerate surgery and agree to undergo surgery;
- •Undergoing hemiarthroplasty (HA) for the first time;
- •Able to walk independently and have intact cognitive function before the injury.
排除标准
- •Bilateral femoral neck fractures;
- •Patients with pathological fractures;
- •Hip dysplasia, rheumatoid osteoarthritis, or other hip disorders;
- •Patients with systemic or localized infections or inflammatory reactions at the surgical site;
- •Patients with other lower limb fractures or severe injuries to other parts of the body; Patients with a history of previous hip surgery.
研究组 & 干预措施
DAA group
Patients with femoral neck fractures undergoing DAA-HA.
干预措施: Direct anterior approach hemiarthroplasty (Procedure)
PLA group
Patients with femoral neck fractures undergoing PLA-HA.
干预措施: Posterior lateral approach hemiarthroplasty (Procedure)
结局指标
主要结局
Harris hip joint function score
时间窗: 1 week, 1 month, and 3 months after surgery
Scores range from 100 to 0, with 90-100 being excellent, 80-89 being good, 70-79 being acceptable, and ≤69 being poor.
VAS pain score
时间窗: 1 week, 1 month, and 3 months after surgery
The highest score is 10 and the lowest score is 0, with the following interpretations: 0 points indicating no pain; 1-3 points indicating mild pain with little impact on daily life; 4-6 points indicating moderate pain affecting daily life and sleep; 7-9 points indicating severe pain significantly affecting quality of life; and 10 points indicating unbearable, extreme pain.
次要结局
- Mortality(3 months after surgery)
- Hemoglobin value(Preoperative and postoperative 1 day)
- Operative time(Intraoperative)
- Intraoperative bleeding volume(Intraoperative)
- Intraoperative blood transfusion rate(Intraoperative)
- Blood creatine kinase value(Preoperative and postoperative 1 day)
- Incidence of complications(Perioperative period)
- Difference in length of both lower limbs(3 days after surgery)
- Postoperative drainage volume(24 hours after surgery)
- Hospital stay(The duration (in days) from admission to discharge, estimated to be no more than 21 days at most.)
研究者
CHEN JIAN
Principal investigator
Fujian Provincial Hospital