Hip ArthropathyNCT03351153
Prediction of the Collapse of Necrotic Femoral Head Using Computed Tomography Scan and X-ray Before Hip Arthroplasty
A study testing X-ray, CT and specimen in people with Hip Arthropathy, run by Hebei Medical University Third Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 32 to 68 years
- Conditions the study is for
- Hip Arthropathy
- What is being tested?
- X-ray, CT and specimen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- No sites listed yet
- Study dates
- 8 Jul 2010to 30 Jan 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 32 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Infection
- Tuberculosis
- Tumor
- Severe osteoporosis
About this study
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
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.
Read the 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.
- Conditions
- Hip Arthropathy
- Being tested
- X-ray, CT, specimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-rayRadiation
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
CTRadiation
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
specimenOther
In the specimen group, femoral head on the affected side was resected during surgery and directly measured with a ruler and vernier caliper.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: specimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At preoperative 1 week
Secondary outcomes (3)
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.
Measured: At preoperative 1 week
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.
Measured: At preoperative 1 week
Negative predictive value
Negative predictive value refers to the proportion of patients with negative screening test result who do not suffer from diseases.
Measured: At preoperative 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start8 Jul 2010
- Primary completion4 Jan 2012
- Study completion30 Jan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip ArthropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Di Qin, Hebei Medical University Third Hospital
- Investigators
- Di Qin, Principal investigator, Third Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03351153
- Sponsor's protocol ID
- HebeiMUth-001
- Status last verified
- Nov 2017
- First submitted
- 13 Nov 2017
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03351153
- Acronym / sponsor ID
- HebeiMUth-001
- Conditions
- Hip Arthropathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Hebei Medical University Third HospitalUniversity, hospital or other
- Study start
- 8 Jul 2010 (actual)
- Primary completion
- 4 Jan 2012 (actual)
- Study completion
- 30 Jan 2012 (actual)
- First posted
- 22 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| X-ray group | Other | Radiation: X-rayIn 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 | Other | Radiation: CTIn 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 | Other | Other: specimenIn the specimen group, femoral head on the affected side was resected during surgery and directly measured with a ruler and vernier caliper. |
Who may qualify
- Ages
- 32 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Infection
- Tuberculosis
- Tumor
- Severe osteoporosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| X-rayIn 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 group |
| CTIn 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 group |
| specimenIn the specimen group, femoral head on the affected side was resected during surgery and directly measured with a ruler and vernier caliper. | Other | Specimen group |
Primary outcome
Sensitivity
Time frame: At preoperative 1 week
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.
3 secondary outcomes
Specificity
Time frame: At preoperative 1 week
positive predictive value
Time frame: At preoperative 1 week
Negative predictive value
Time frame: At preoperative 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Di Qin principal investigator
Third Hospital of Hebei Medical University
Questions about this trial
What is this clinical trial studying?
A study testing X-ray, CT and specimen in people with Hip Arthropathy, run by Hebei Medical University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: At preoperative 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2017.