search
Back to results

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

Primary Purpose

Hip Arthropathy

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
X-ray
CT
specimen
Sponsored by
Hebei Medical University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Hip Arthropathy

Eligibility Criteria

32 Years - 68 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Other

    Other

    Other

    Arm Label

    X-ray group

    CT group

    Specimen group

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

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

    Full Information

    First Posted
    November 13, 2017
    Last Updated
    November 17, 2017
    Sponsor
    Hebei Medical University Third Hospital
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03351153
    Brief Title
    Prediction of the Collapse of Necrotic Femoral Head Using Computed Tomography Scan and X-ray Before Hip Arthroplasty
    Official 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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    July 8, 2010 (Actual)
    Primary Completion Date
    January 4, 2012 (Actual)
    Study Completion Date
    January 30, 2012 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Hebei Medical University Third Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hip Arthropathy

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    86 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    X-ray group
    Arm Type
    Other
    Arm 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.
    Arm Title
    CT group
    Arm Type
    Other
    Arm 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.
    Arm Title
    Specimen group
    Arm Type
    Other
    Arm Description
    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
    Radiation
    Intervention Name(s)
    X-ray
    Intervention 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
    Intervention Type
    Radiation
    Intervention Name(s)
    CT
    Intervention 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
    Intervention Type
    Other
    Intervention Name(s)
    specimen
    Intervention Description
    In the specimen group, femoral head on the affected side was resected during surgery and directly measured with a ruler and vernier caliper.
    Primary Outcome Measure Information:
    Title
    Sensitivity
    Description
    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.
    Time Frame
    At preoperative 1 week
    Secondary Outcome Measure Information:
    Title
    Specificity
    Description
    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.
    Time Frame
    At preoperative 1 week
    Title
    positive predictive value
    Description
    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.
    Time Frame
    At preoperative 1 week
    Title
    Negative predictive value
    Description
    Negative predictive value refers to the proportion of patients with negative screening test result who do not suffer from diseases.
    Time Frame
    At preoperative 1 week

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    32 Years
    Maximum Age & Unit of Time
    68 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Di Qin
    Organizational Affiliation
    Third Hospital of Hebei Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs