OrthopedicsNCT04779112
Detecting Acetabulum Movement After Total Hip Arthroplasty From Serial Plain Radiographs
An observational study of Orthopedics, run by Taipei Medical University.
Trial summary
This study mainly measures the orientation of acetabulum cup post total hip arthroplasty. Using "Liaw's Version", a new and accurate standardization method, investigators are trying to analyze acetabulum cup anterversion change postoperatively. Read more about this study
- Who is it for?
- Ages 40 to 85 years
- Conditions the study is for
- Orthopedics
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Mar 2021to Jan 2022
- 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 40 to 85 years
- All sexes
- Adult, Older adult
Study population: Patients of hospital
Who may be able to join
- Patients undergone total hip arthroplasty
- Patients undergone total hip arthroplasty with more than two postoperative X-ray plain films
Who cannot join
- Patients with postoperative periprosthetic fracture(s)
- Patients with postoperative infection
- Patients undergone revision total hip arthroplasty
Trial locations and contacts
No sites are listed yet.
About this study
This study mainly measures the orientation of acetabulum cup post total hip arthroplasty. Using "Liaw's Version", a new and accurate standardization method, investigators are trying to analyze acetabulum cup anterversion change postoperatively.
Read the detailed description
Patients undergoing total hip arthroplasty have generally good prognosis. However, clinically there was still a minority of patients who suffered from persistent postoperative pain. Dislocations of hip leading to revision surgeries were as well observed in some patients.
This study mainly measures the orientation of acetabulum cup post total hip arthroplasty. Using "Liaw's Version", a new and accurate standardization method, investigators are trying to analyze acetabulum cup anterversion change postoperatively.
As previously known, the anteversion of acetabulum cup determines the range of motion, stability, and the function after total hip arthroplasty. Cup malalignment increase impingement, dislocation, cup migration, and polyethylene wear. Finding a pattern may help the early diagnosis of acetabular loosening.
- Conditions
- Orthopedics
What is being measured
The primary outcome is the main question the study is designed to answer.
Analyze acetabulum cup anterversion change postoperatively
Using "Liaw's Version", a new and accurate standardization method developed, investigators are trying to analyze acetabulum cup anterversion change postoperatively.
Measured: 1 week
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 completionJan 2022 (estimated)
- Study completionJan 2022 (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
- 50 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
- NCT04779112
- Sponsor's protocol ID
- N201912060
- Status last verified
- Mar 2021
- 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
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
- Detecting Acetabulum Movement After Total Hip Arthroplasty From Serial Plain Radiographs
- ClinicalTrials.gov ID
- NCT04779112
- Acronym / sponsor ID
- N201912060
- Conditions
- Orthopedics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- Mar 2021 (estimated)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (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.
This study mainly measures the orientation of acetabulum cup post total hip arthroplasty. Using "Liaw's Version", a new and accurate standardization method, investigators are trying to analyze acetabulum cup anterversion change postoperatively.
Detailed description
Patients undergoing total hip arthroplasty have generally good prognosis. However, clinically there was still a minority of patients who suffered from persistent postoperative pain. Dislocations of hip leading to revision surgeries were as well observed in some patients.
This study mainly measures the orientation of acetabulum cup post total hip arthroplasty. Using "Liaw's Version", a new and accurate standardization method, investigators are trying to analyze acetabulum cup anterversion change postoperatively.
As previously known, the anteversion of acetabulum cup determines the range of motion, stability, and the function after total hip arthroplasty. Cup malalignment increase impingement, dislocation, cup migration, and polyethylene wear. Finding a pattern may help the early diagnosis of acetabular loosening.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients of hospital
Key inclusion criteria (2 listed)
- Patients undergone total hip arthroplasty
- Patients undergone total hip arthroplasty with more than two postoperative X-ray plain films
Key exclusion criteria (3 listed)
- Patients with postoperative periprosthetic fracture(s)
- Patients with postoperative infection
- Patients undergone revision total hip arthroplasty
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
Analyze acetabulum cup anterversion change postoperatively
Time frame: 1 week
Using "Liaw's Version", a new and accurate standardization method developed, investigators are trying to analyze acetabulum cup anterversion change postoperatively.
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.
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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 2 inclusion and 3 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?
Analyze acetabulum cup anterversion change postoperatively (time frame: 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 3 Mar 2021.