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

Hip Arthropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03351153
• Other study ID #: HebeiMUth-001
• Status: Completed
• Phase: N/A
• First received: November 13, 2017
• Last updated: November 17, 2017
• Start date: July 8, 2010
• Est. completion date: January 30, 2012

Study information

• Verified date: November 2017
• Source: Hebei Medical University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: January 30, 2012
• Est. primary completion date: January 4, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 32 Years to 68 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Arthropathy
• Joint Diseases

Intervention

Radiation:
• 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
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

Other:
• specimen
In the specimen group, femoral head on the affected side was resected during surgery and directly measured with a ruler and vernier caliper.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University Third Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	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.	At preoperative 1 week
Secondary	Specificity	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.	At preoperative 1 week
Secondary	positive predictive value	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.	At preoperative 1 week
Secondary	Negative predictive value	Negative predictive value refers to the proportion of patients with negative screening test result who do not suffer from diseases.	At preoperative 1 week