跳至主要内容
临床试验/NCT05171140
NCT05171140Unknown不适用

Influence of Different Spatial Distribution of Hollow Screws on Blood Supply and Prognosis of Femoral Neck Fractures in the Elderly

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2020年9月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
68
试验地点
1
主要终点
comparison of hip joint function at 12 months

研究概览

简要总结

Femoral neck fracture is a common type of fracture in the elderly. For those without significant displacement (Garden I, II), more hip-preserving treatment strategies are adopted. The classic parallel hollow screw internal fixation for hip-preserving treatment is based on the sliding compression theory, and a clinical debate has gradually emerged, that is, the positive triangle And the two different spatial distribution methods of hollow nails and inverted triangle, which one is better. In addition, the distribution of hollow nails in actual operations is difficult to achieve a standard triangular distribution, and the damage to the epiphyseal vessels in the femoral head caused by repeated drilling of the guide needle cannot always be ignored. The relationship between the distribution and injury of blood vessels in the femoral head and the spatial distribution of hollow screws on the prognosis of head necrosis of non-displaced femoral neck fractures in the elderly is worth studying. This topic is based on the three advantages of TianJi orthopedic robots used in the elderly femoral neck fracture hollow nail hip-saving surgery: 1.standardized triangular nail placement with strong repeatability; 2. precise nail placement to reduce the risk of screw penetration; 3. limited guide pins The number of drill holes is to rule out repeated drill holes that damage the blood vessels in the femoral head. The preoperative and postoperative vascular injury in the femoral head (enhanced MRI of the femoral head) was compared to assess the prognosis of patients, and to clarify the influence of the spatial distribution of hollow screws on the blood supply and prognosis of the femoral neck fracture in the elderly.

详细描述

the investigators choose 60-80-year-old Garden I or II patients with initial fractures. Hollow nails are the first choice for treatment of these patients. However, the spatial arrangement of hollow nails, local blood supply, and biomechanical properties have a greater impact on the prognosis of fractures. , There are still some controversies, which are also the current research hotspots. Our research conclusions may increase the success rate of hip preservation and will guide the treatment of these patients. This study is based on the precise placement of nails by the Dimensity orthopedic robot, and compares the vascular injury of the femoral head before and after the nail placement (femoral head enhanced MRI) to assess the prognosis of the patient. The influence of blood supply and prognosis of femoral neck fracture in the elderly.

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 (Participant)

入排标准

年龄范围
60 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • A new initial intracapsular fracture of the femoral neck;
  • Garden classification I or II;
  • Accept closed reduction robot-assisted hollow nail surgery;
  • ASA score 1-2, can tolerate anesthesia;
  • Age 60-80 years old (inclusive);
  • Able to fully understand and voluntarily sign informed consent.

排除标准

  • Old or pathological fractures;
  • Patients with acetabular fracture;
  • Those who have general conditions or accompanying diseases that make it difficult for people to tolerate surgery, such as: coagulation dysfunction, or heart, liver, and kidney dysfunction;
  • Severe infections systemically or locally;
  • Those who refuse to sign informed consent;
  • In any case, if the researcher believes that the patient is not suitable for this treatment or there are other factors that affect the efficacy of the observation of this study.

结局指标

主要结局

comparison of hip joint function at 12 months

时间窗: 12 months after surgery

Harris score

Imaging evaluation of the vascular condition of the femoral head epiphysis before surgery

时间窗: One day before surgery

Imaging evaluation of the vascular condition of the femoral head epiphysis

comparison of hip joint function at 6 months

时间窗: 6 months after surgery

Harris score

Imaging evaluation of the vascular condition of the femoral head epiphysis after surgery

时间窗: 2 months after surgery

Imaging evaluation of the vascular condition of the femoral head epiphysis

次要结局

  • Intraoperative indicators-surgical blood loss(Intraoperative)
  • Intraoperative indicators-operation time(Intraoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验