- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04780100
Distinguishing Acetabulum Cup Retroversion From Anteversion on Anteroposterior Radiographs After Total Hip Arthroplasty
March 1, 2021 updated by: Taipei Medical University
In this study, investigators will demonstrate and prove a ellipse method (Liaw's version) for measurement and detection of acetabulum cup retroversion.
Study Overview
Status
Unknown
Conditions
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 Type
Observational
Enrollment (Anticipated)
20
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
30 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients from Shuang Ho Hospital
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
10 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
March 1, 2021
Primary Completion (Anticipated)
May 1, 2021
Study Completion (Anticipated)
May 1, 2021
Study Registration Dates
First Submitted
February 22, 2021
First Submitted That Met QC Criteria
March 1, 2021
First Posted (Actual)
March 3, 2021
Study Record Updates
Last Update Posted (Actual)
March 3, 2021
Last Update Submitted That Met QC Criteria
March 1, 2021
Last Verified
July 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- N202005040
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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