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
About this trial
This is an interventional diagnostic trial for Hip Arthropathy
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
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
NCT ID
NCT03351153
First Posted
November 13, 2017
Last Updated
November 17, 2017
Sponsor
Hebei Medical University Third Hospital
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
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