Prediction of the Collapse of Necrotic Femoral Head Using Computed Tomography Scan and X-ray Before Hip Arthroplasty

Not Applicable

Completed

• Conditions: Hip Arthropathy
• Interventions: Radiation: X-ray; Radiation: CT; Other: specimen

• Registration Number: NCT03351153
• Lead Sponsor: Hebei Medical University Third Hospital

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.

Study Timeline

• Study Start: 2010-07-08
• Primary Completion: 2012-01-04
• Study Completion: 2012-01-30
• Status Verified: 2017-11
• Study First Submitted: 2017-11-13
• Study First Submitted QC: 2017-11-17
• Last Update Submitted: 2017-11-17
• Study First Posted: 2017-11-22
• Last Update Posted: 2017-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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
• Tumor
• Severe osteoporosis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
X-ray group	X-ray	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.
CT group	CT	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.
Specimen group	specimen	In the specimen group, femoral head on the affected side was resected during surgery and directly measured with a ruler and vernier caliper.

Primary Outcome Measures

Name	Time	Method
Sensitivity	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 Outcome Measures

Name	Time	Method
positive predictive value	At preoperative 1 week	Positive predictive value refers to the proportion of patients with actual illness among all positive cases, can reflect the possibility of affecting target disease in patients with positive screening test result.
Negative predictive value	At preoperative 1 week	Negative predictive value refers to the proportion of patients with negative screening test result who do not suffer from diseases.
Specificity	At preoperative 1 week	Specificity refers to true negative rate, the percentage of patients with actual disease-free who are correctly judged as disease-free according to the diagnostic criteria. The high specificity indicates high accuracy of diagnosis.