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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03351153
Enrollment
86
Registered
2017-11-22
Start date
2010-07-08
Completion date
2012-01-30
Last updated
2017-11-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hip Arthropathy

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.

Interventions

RADIATIONX-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

RADIATIONCT

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

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

Sponsors

Hebei Medical University Third Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
32 Years to 68 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
SensitivityAt preoperative 1 weekSensitivity 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

MeasureTime frameDescription
SpecificityAt preoperative 1 weekSpecificity 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.
positive predictive valueAt preoperative 1 weekPositive 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 valueAt preoperative 1 weekNegative predictive value refers to the proportion of patients with negative screening test result who do not suffer from diseases.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026