Prediction of the Collapse of Necrotic Femoral Head Using Computed Tomography Scan and X-ray Before Hip Arthroplasty: Study Protocol for a Single-center, Open-label, Diagnostic Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 主要终点
- Sensitivity
研究概览
简要总结
To verify that CT scan and X-ray can predict the collapse of the necrotic femoral head before hip arthroplasty and effectively guide the surgical management.
详细描述
Osteonecrosis of the femoral head (ONFH) is a common and frequently occurring disease. The main clinical manifestations are hip pain and dysfunction. The etiology and pathogenesis of ONFH caused by various reasons are the problems that have not been solved yet in the field of orthopedics. If want to achieve satisfactory therapeutic effect, surgical choice is essential. It is very important for prognosis to master the indications of operation and take appropriate treatment measures, especially the great difference between palliative surgery and hip arthroplasty.
To determine whether the femoral head collapses and the degree of collapse of the articular cartilage of the femoral head can help physicians to select an optimal surgical plan. Chinese scholars commonly believe that if the femoral head collapse is less than 2 mm, investigators can choose autologous bone graft, allogeneic bone graft and other palliative surgery. If the femoral head collapse is more than 2 mm, investigators can choose total hip arthroplasty. However, above standard has not been extensively accepted worldwide.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 32 Years 至 68 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Unilateral ONFH confirmed preoperatively (FICAT stages III and IV; Appendix 1)14
- •Unilateral total hip arthroplasty
- •Age range: 32-68 years
- •Irrespective of sex
- •Sign the informed consent
排除标准
- •Infection
- •Tuberculosis
- •Severe osteoporosis
研究组 & 干预措施
X-ray group
In the X-ray group, the changes in femoral head height were measured with X-ray in an anteroposterior position of the pelvis (healthy and affected sides of the hip) at preoperative 1 week.
干预措施: X-ray (Radiation)
CT group
In the CT group, changes of femoral head height were measured with CT scan on bilateral hips (healthy side and affected side) at preoperative 1 week.
干预措施: CT (Radiation)
Specimen group
In the specimen group, femoral head on the affected side was resected during surgery and directly measured with a ruler and vernier caliper.
干预措施: specimen (Other)
结局指标
主要结局
Sensitivity
时间窗: At preoperative 1 week
Sensitivity refers to true positive rate, the percentage of patients with actual illness who was correctly diagnosed in overall patients. High sensitivity indicated high correct rate of femoral head collapse.
次要结局
- positive predictive value(At preoperative 1 week)
- Negative predictive value(At preoperative 1 week)
- Specificity(At preoperative 1 week)
研究者
Di Qin
Principal Investigator
Hebei Medical University Third Hospital
