Acetabular DysplasiaNCT03541122
Three Novel Radiological Indicators for Diagnosis of Adult Acetabular Dysplasia
An observational study of Acetabular Dysplasia, run by Hebei Medical University Third Hospital at 1 site in China.
Trial summary
Acetabular dysplasia often accompanies by acetabular bone hyperplasia and osteonecrosis of the femoral head. These pathological changes can alter the position of the center of the femoral head. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Acetabular Dysplasia
- What is being tested?
- pelvic X-ray examinations
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2018to Dec 2019
- Phase
- Observational
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Potential patients will be informed of the study details through an announcement issued through the bulletin board of the Third Hospital of Hebei Medical University. Interested patients will directly contact the principle investigator via telephone, and among them, eligible patients will be required to provide written consent prior to the participation in the trial.
Who may be able to join
- No experience in hip replacement, pelvic fixation or external fixation, and proximal femoral surgery;
- No marked pelvic tilt;
- No hip dislocation;
- No obvious hip deformity, such as significant collapse of the femoral head and severe hip traumatic arthritis;
- No significant lesions in the pelvis or proximal femur;
- Aged over 16 years;
- Provision of written informed consent.
Who cannot join
- Those with advanced osteoarthritis;
- Those with osteoarthritis secondary to acetabular dysplasia;
- Those with ankylosing spondylitis involving the hip joint;
- Those with rheumatoid arthritis;
- Those with inflammatory inflammation of the hip joint;
- Those with tumor lesions in the hip joint.
Trial locations and contacts
1 site in 1 country.
China1 site
Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050051
About this study
Official title: Three Novel Radiological Indicators for Diagnosis of Adult Acetabular Dysplasia: a Self-controlled, Diagnostic Trial
Acetabular dysplasia often accompanies by acetabular bone hyperplasia and osteonecrosis of the femoral head. These pathological changes can alter the position of the center of the femoral head. Thus, measurement errors will be generated on the anteroposterior radiographs of the adult pelvis involving centre-edge angle, acetabular angle (Sharp angle), and acetabular head index, eventually resulting in the inaccurate diagnosis of acetabular dysplasia. Herein, the investigators describe the protocol to verify three novel X-ray indicators, including offshoring index (OFI), moving up index (MUI) and teardrop baseline offshoring index (TBOI) of the femoral head. All data will be expressed as relative ratios, as the investigators expect to make an accurate diagnosis through avoiding the generation of errors resulting from measurement angles.
Read the detailed description
Acetabular dysplasia is a developmental malformation of the hip joint where the acetabulum become shallow and cannot fully cover the femoral head and the centre of the hip joint moves outward, resulting in an increased risk for joint subluxation or dislocation.
Current diagnosis of acetabular dysplasia mainly depends on the pelvic anteroposterior X-ray film to understand whether there is dislocation of the hip joint, whether the concentricity of the femoral head and acetabulum is consistent, and whether there is secondary osteoarthritis or other hip diseases, such as femoral head ischemic necrosis, hip joint tuberculosis, and rheumatoid arthritis. The commonly used measurement indicators include centre-edge (CE) angle, acetabular angle (Sharp angle), and acetabular head index (AHI). Moreover, some differences exist in the measurement results between male and female patients. Acetabular dysplasia often accompanies by acetabular bone hyperplasia and necrosis of the femoral head, which have a greater impact on radiographic measurements, especially when measured with angles. It is difficult to determine the radiological landmark for the lateral edge of the acetabular roof due to the existence of bone hyperplasia, which produces a great influence on the accuracy of the measurement of the centre-edge angle and Sharp angle.
- Conditions
- Acetabular Dysplasia
- Being tested
- pelvic X-ray examinations
- Medical subject headings
- Hip Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pelvic X-ray examinationsDiagnostic test
Measurement indicators will include OFI, MUI, TBOI, CE angle, Sharp angle and AHI of the affected and healthy femoral heads.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Patients will undergo pelvic X-ray examinations. Measurement indicators will include OFI, MUI, TBOI, CE angle, Sharp angle and AHI of the affected and healthy femoral heads. The investigators will determine the sensitivity and specificity of OFI, MUI and TBOI for the diagnosis of adult acetabular dysplasia, and compare the accuracy of diagnosis between these three indicators and CE angle, sharp angle, and AHI. Further analysis of risk factors for hip function will be implemented. Receives: Diagnostic Test: pelvic X-ray examinations |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity of offshoring index (OFI)
The sensitivity represents the percentage of actual patients who are correctly diagnosed with a disease. A higher sensitivity indicates a higher rate of correct diagnosis for acetabular dysplasia.
Measured: One day after hospitalization
Secondary outcomes (5)
The specificity of OFI,MUI and TBOI
The specificity represents the percentage of disease-free patients who are correctly diagnosed with no disease. A higher specificity indicates a higher rate of correct diagnosis for acetabular dysplasia.
Measured: One day after hospitalization
The positive predictive value of OFI,MUI and TBOI
The positive predictive value represents the probability that the patient actually suffer from the disease (true positive rate) in all positive cases.
Measured: One day after hospitalization
The negative predictive value of OFI,MUI and TBOI
The negative predictive value represents the probability that the patient does not suffer from have the disease. This value is often influenced by the sensitivity, specificity, and prevalence in all cases.
Measured: One day after hospitalization
The positive likelihood ratio of OFI,MUI and TBOI
The positive likelihood ratio represents the probability of a patient who has the disease testing positive divided by the probability of a patient who does not have the disease testing positive.
Measured: One day after hospitalization
The negative likelihood ratio of OFI,MUI and TBOI
The negative likelihood ratio represents the probability of a patient who has the disease testing negative divided by the probability of a patient who does not have the disease testing negative.
Measured: One day after hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2018
- Study start1 Feb 2018
- Primary completionOct 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acetabular DysplasiaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
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, M.S., Principal investigator, Third Hospital of Hebei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03541122
- Sponsor's protocol ID
- HebeiMUth-003
- Status last verified
- May 2018
- First submitted
- 17 May 2018
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three Novel Radiological Indicators for Diagnosis of Adult Acetabular Dysplasia: a Self-controlled, Diagnostic Trial
- ClinicalTrials.gov ID
- NCT03541122
- Acronym / sponsor ID
- HebeiMUth-003
- Conditions
- Acetabular Dysplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hebei Medical University Third HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 30 May 2018 (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.
Acetabular dysplasia often accompanies by acetabular bone hyperplasia and osteonecrosis of the femoral head. These pathological changes can alter the position of the center of the femoral head. Thus, measurement errors will be generated on the anteroposterior radiographs of the adult pelvis involving centre-edge angle, acetabular angle (Sharp angle), and acetabular head index, eventually resulting in the inaccurate diagnosis of acetabular dysplasia. Herein, the investigators describe the protocol to verify three novel X-ray indicators, including offshoring index (OFI), moving up index (MUI) and teardrop baseline offshoring index (TBOI) of the femoral head. All data will be expressed as relative ratios, as the investigators expect to make an accurate diagnosis through avoiding the generation of errors resulting from measurement angles.
Detailed description
Acetabular dysplasia is a developmental malformation of the hip joint where the acetabulum become shallow and cannot fully cover the femoral head and the centre of the hip joint moves outward, resulting in an increased risk for joint subluxation or dislocation.
Current diagnosis of acetabular dysplasia mainly depends on the pelvic anteroposterior X-ray film to understand whether there is dislocation of the hip joint, whether the concentricity of the femoral head and acetabulum is consistent, and whether there is secondary osteoarthritis or other hip diseases, such as femoral head ischemic necrosis, hip joint tuberculosis, and rheumatoid arthritis. The commonly used measurement indicators include centre-edge (CE) angle, acetabular angle (Sharp angle), and acetabular head index (AHI). Moreover, some differences exist in the measurement results between male and female patients. Acetabular dysplasia often accompanies by acetabular bone hyperplasia and necrosis of the femoral head, which have a greater impact on radiographic measurements, especially when measured with angles. It is difficult to determine the radiological landmark for the lateral edge of the acetabular roof due to the existence of bone hyperplasia, which produces a great influence on the accuracy of the measurement of the centre-edge angle and Sharp angle.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | – | Diagnostic Test: pelvic X-ray examinationsPatients will undergo pelvic X-ray examinations. Measurement indicators will include OFI, MUI, TBOI, CE angle, Sharp angle and AHI of the affected and healthy femoral heads. The investigators will determine the sensitivity and specificity of OFI, MUI and TBOI for the diagnosis of adult acetabular dysplasia, and compare the accuracy of diagnosis between these three indicators and CE angle, sharp angle, and AHI. Further analysis of risk factors for hip function will be implemented. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Potential patients will be informed of the study details through an announcement issued through the bulletin board of the Third Hospital of Hebei Medical University. Interested patients will directly contact the principle investigator via telephone, and among them, eligible patients will be required to provide written consent prior to the participation in the trial.
Key inclusion criteria (7 listed)
- No experience in hip replacement, pelvic fixation or external fixation, and proximal femoral surgery;
- No marked pelvic tilt;
- No hip dislocation;
- No obvious hip deformity, such as significant collapse of the femoral head and severe hip traumatic arthritis;
- No significant lesions in the pelvis or proximal femur;
Key exclusion criteria (6 listed)
- Those with advanced osteoarthritis;
- Those with osteoarthritis secondary to acetabular dysplasia;
- Those with ankylosing spondylitis involving the hip joint;
- Those with rheumatoid arthritis;
- Those with inflammatory inflammation of the hip joint;
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 |
|---|---|---|
| pelvic X-ray examinationsMeasurement indicators will include OFI, MUI, TBOI, CE angle, Sharp angle and AHI of the affected and healthy femoral heads. | Diagnostic test | Experimental group |
Primary outcome
The sensitivity of offshoring index (OFI)
Time frame: One day after hospitalization
The sensitivity represents the percentage of actual patients who are correctly diagnosed with a disease. A higher sensitivity indicates a higher rate of correct diagnosis for acetabular dysplasia.
5 secondary outcomes
The specificity of OFI,MUI and TBOI
Time frame: One day after hospitalization
The positive predictive value of OFI,MUI and TBOI
Time frame: One day after hospitalization
The negative predictive value of OFI,MUI and TBOI
Time frame: One day after hospitalization
The positive likelihood ratio of OFI,MUI and TBOI
Time frame: One day after hospitalization
The negative likelihood ratio of OFI,MUI and TBOI
Time frame: One day after hospitalization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2018.
- Individual participant dataSharing planned: Undecided
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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, M.S. principal investigator
Third Hospital of Hebei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acetabular Dysplasia, run by Hebei Medical University Third Hospital at 1 site in China.
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 7 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
The sensitivity of offshoring index (OFI) (time frame: One day after hospitalization). 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 30 May 2018.