OrthopedicsNCT04780100
Distinguishing Acetabulum Cup Retroversion From Anteversion on Anteroposterior Radiographs After Total Hip Arthroplasty
An observational study of Orthopedics, run by Taipei Medical University.
Trial summary
In this study, investigators will demonstrate and prove a ellipse method (Liaw's version) for measurement and detection of acetabulum cup retroversion. Read more about this study
- Who is it for?
- Ages 30 to 90 years
- Conditions the study is for
- Orthopedics
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to May 2021
- 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 30 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients from Shuang Ho Hospital
Who may be able to join
- Patients undergone total hip arthroplasty
- Patients undergone total hip arthroplasty with more than two postoperative anteroposterior radiographs of pelvis
- Patients undergone total hip arthroplasty with postoperative pelvic CT
Who cannot join
- Patients with congenital pelvis abnormality or pelvic fracture history
- Patients with postoperative periprosthetic fracture(s)
- Patients with postoperative infection or implants loosening
- Patients undergone total hip arthroplasty without more than two postoperative anteroposterior radiographs of pelvis
- Patients undergone total hip arthroplasty without postoperative pelvic CT
Trial locations and contacts
No sites are listed yet.
About this study
In this study, investigators will demonstrate and prove a ellipse method (Liaw's version) for measurement and detection of acetabulum cup retroversion.
Read the detailed description
Total hip arthroplasty (THA) is considered to be the best and most reliable treatment of end-stage hip disorders with satisfactory long-term clinical outcomes. However,the incidence of postoperative dislocation ranges from 0.3% to 3% in primary THA. The most important risk factor is malpositioning of implant components. Generally, excessive anteversion and retroversion increase risk of anterior and posterior hip dislocation respectively. Several radiological methods have been proposed to measure anteversion of the acetabular cup on plain radiographs, but most of these methods cannot accurately distinguish cup retroversion from anteversion. In this study, investigators will demonstrate and prove a ellipse method (Liaw's version) for measurement and detection of acetabulum cup retroversion.
- Conditions
- Orthopedics
What is being measured
The primary outcome is the main question the study is designed to answer.
A computerized ellipse method (Liaw's version) for measurement and detection of acetabulum cup retroversion.
Total hip arthroplasty (THA) is considered to be the best and most reliable treatment of end-stage hip disorders with satisfactory long-term clinical outcomes. However,the incidence of postoperative dislocation ranges from 0.3% to 3% in primary THA. The most important risk factor is malpositioning of implant components. Generally, excessive anteversion and retroversion increase risk of anterior and posterior hip dislocation respectively. Several radiological methods have been proposed to measure anteversion of the acetabular cup on plain radiographs, but most of these methods cannot accurately distinguish cup retroversion from anteversion. In this article, we will demonstrate and prove a computerized ellipse method (Liaw's version) for measurement and detection of acetabulum cup retroversion.
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study startMar 2021 (estimated)
- Primary completionMay 2021 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OrthopedicsStudies of the same condition, open and under way.
- More trials run by Taipei Medical UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chen-Kun Liaw, Study chair, Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780100
- Sponsor's protocol ID
- N202005040
- Status last verified
- Jul 2020
- First submitted
- 22 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distinguishing Acetabulum Cup Retroversion From Anteversion on Anteroposterior Radiographs After Total Hip Arthroplasty
- ClinicalTrials.gov ID
- NCT04780100
- Acronym / sponsor ID
- N202005040
- Conditions
- Orthopedics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- May 2021 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 3 Mar 2021 (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.
In this study, investigators will demonstrate and prove a ellipse method (Liaw's version) for measurement and detection of acetabulum cup retroversion.
Detailed description
Total hip arthroplasty (THA) is considered to be the best and most reliable treatment of end-stage hip disorders with satisfactory long-term clinical outcomes. However,the incidence of postoperative dislocation ranges from 0.3% to 3% in primary THA. The most important risk factor is malpositioning of implant components. Generally, excessive anteversion and retroversion increase risk of anterior and posterior hip dislocation respectively. Several radiological methods have been proposed to measure anteversion of the acetabular cup on plain radiographs, but most of these methods cannot accurately distinguish cup retroversion from anteversion. In this study, investigators will demonstrate and prove a ellipse method (Liaw's version) for measurement and detection of acetabulum cup retroversion.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 30 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients from Shuang Ho Hospital
Key inclusion criteria (3 listed)
- Patients undergone total hip arthroplasty
- Patients undergone total hip arthroplasty with more than two postoperative anteroposterior radiographs of pelvis
- Patients undergone total hip arthroplasty with postoperative pelvic CT
Key exclusion criteria (5 listed)
- Patients with congenital pelvis abnormality or pelvic fracture history
- Patients with postoperative periprosthetic fracture(s)
- Patients with postoperative infection or implants loosening
- Patients undergone total hip arthroplasty without more than two postoperative anteroposterior radiographs of pelvis
- Patients undergone total hip arthroplasty without postoperative pelvic CT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
A computerized ellipse method (Liaw's version) for measurement and detection of acetabulum cup retroversion.
Time frame: 10 days
Total hip arthroplasty (THA) is considered to be the best and most reliable treatment of end-stage hip disorders with satisfactory long-term clinical outcomes. However,the incidence of postoperative dislocation ranges from 0.3% to 3% in primary THA. The most important risk factor is malpositioning of implant components. Generally, excessive anteversion and retroversion increase risk of anterior and posterior hip dislocation respectively. Several radiological methods have been proposed to measure anteversion of the acetabular cup on plain radiographs, but most of these methods cannot accurately distinguish cup retroversion from anteversion. In this article, we will demonstrate and prove a computerized ellipse method (Liaw's version) for measurement and detection of acetabulum cup retroversion.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- 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.
Chen-Kun Liaw study chair
Taipei Medical University
Questions about this trial
What is this clinical trial studying?
An observational study of Orthopedics, run by Taipei Medical University.
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 3 inclusion and 5 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 3 Mar 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chen-Kun Liaw (+886963969162, chenkunliaw@tmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A computerized ellipse method (Liaw's version) for measurement and detection of acetabulum cup retroversion. (time frame: 10 days). 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 3 Mar 2021.