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

NCT03351153 | Completed DMC

• 1 other identifier: HebeiMUth-001
• Study Type: interventional
• Target: 86
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hip Arthropathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Specificity

  At preoperative 1 week

• positive predictive value

  At preoperative 1 week

• Negative predictive value

  At preoperative 1 week

Study Arms (3)

X-ray group

OTHER

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.

Radiation: X-ray

CT group

OTHER

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.

Radiation: CT

Specimen group

OTHER

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

Other: specimen

Interventions

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

X-ray group

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

CT group

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.

Specimen group

Eligibility Criteria

• Age: 32 Years - 68 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Infection
• Tuberculosis
• Tumor
• Severe osteoporosis

Sponsors & Collaborators

• Hebei Medical University Third Hospital: lead

MeSH Terms

Interventions

X-Rays

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Officials

• Di Qin

  Third Hospital of Hebei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 13, 2017
• First Posted: November 22, 2017
• Study Start: July 8, 2010
• Primary Completion: January 4, 2012
• Study Completion: January 30, 2012
• Last Updated: November 22, 2017

Record last verified: 2017-11