Skip to main content
OpenTrials
Completed

NCT Number: NCT03351153

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hip Arthropathy

Age range

32 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

X-Ray

Radiation

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

Radiation

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

Other

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

Primary outcomes

  1. 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

  1. Specificity

    Time frame: 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.

  2. positive predictive value

    Time frame: 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.

  3. Negative predictive value

    Time frame: At preoperative 1 week

    Negative predictive value refers to the proportion of patients with negative screening test result who do not suffer from diseases.

Sponsors and collaborators

Lead sponsor

Hebei Medical University Third Hospital

Other

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Nov 22, 2017
Registry last updated
Nov 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.