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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hip Arthropathy
- Sponsor
- Hebei Medical University Third Hospital
- Enrollment
- 86
- Primary Endpoint
- Sensitivity
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Di Qin
Principal Investigator
Hebei Medical University Third Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Infection
- •Tuberculosis
- •Severe osteoporosis
Outcomes
Primary Outcomes
Sensitivity
Time Frame: 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.
Secondary Outcomes
- positive predictive value(At preoperative 1 week)
- Negative predictive value(At preoperative 1 week)
- Specificity(At preoperative 1 week)