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

Hebei Medical University Third Hospital

Status: Completed

Conditions: Hip Arthropathy

Treatments: Other: specimen; Radiation: X-ray; Radiation: CT

Study type: Interventional

Funder types: Other

Identifiers

NCT03351153

HebeiMUth-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 86 patients

Sex: All

Ages: 32 to 68 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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86 participants in 3 patient groups

X-ray group

Other group

Description:

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.

Treatment:

Radiation: X-ray

CT group

Other group

Description:

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.

Treatment:

Radiation: CT

Specimen group

Other group

Description:

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

Treatment:

Other: specimen