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

NCT ID: NCT03351153

Last Updated: 2017-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-08

Study Completion Date

2012-01-30

Brief Summary

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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

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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.

Conditions

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Hip Arthropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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X-ray group

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.

Group Type OTHER

X-ray

Intervention Type 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 group

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.

Group Type OTHER

CT

Intervention Type 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 group

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

Group Type OTHER

specimen

Intervention Type OTHER

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

Interventions

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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

Intervention Type RADIATION

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

Intervention Type RADIATION

specimen

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

32 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hebei Medical University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Di Qin

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Di Qin

Role: PRINCIPAL_INVESTIGATOR

Third Hospital of Hebei Medical University

Other Identifiers

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HebeiMUth-001

Identifier Type: -

Identifier Source: org_study_id