ArthroplastyNCT02554149
Radiological Measurement of Femoral Stem Version Using Lateral Decubitus Method: A Prospective Study
An observational study of Arthroplasty and Total Hip Replacement, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The purpose of this study was to develop a radiological method to measure stem anteversion and to determine its validity and reliability. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Arthroplasty, Total Hip Replacement
- What is being tested?
- Radiological measurement of femoral stem version
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2015to Mar 2016
- How long will I take part?
- 1 Year
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients who underwent THR between October 2015 and December 2015
Who may be able to join
- Investigators recruited 40 consecutive patients who underwent THR between October 2015 and December 2015
Who cannot join
- patients who could not extend the hip because of a residual flexion contracture.
- who had a flexion contracture of the knee or who could not flex the hip to 90° even after THR were excluded because participants could not adopt the posture required for the particular radiographs and CT scans.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul national University Bundang Hospital
Seongnam-si, Gyeounggi-do, 463-707
About this study
The purpose of this study was to develop a radiological method to measure stem anteversion and to determine its validity and reliability.
Read the detailed description
Version of the femoral stem is an important factor influencing the risk of dislocation after total hip replacement (THR) as well as the position of the acetabular component. However, there is no radiological method of measuring stem anteversion described in the literature. Investigators propose a radiological method to measure stem version and have assessed its reliability and validity. In 40 patients who underwent THR, a hip radiograph and CT scan were taken to measure stem anteversion.
- Conditions
- Arthroplasty, Total Hip Replacement
- Being tested
- Radiological measurement of femoral stem version
- Keywords
- total hip, stem version, replacement, hip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiological measurement of femoral stem versionRadiation
particular radiographs( lateral decubitus view) and CT scans
| Study group | Role | What they receive |
|---|---|---|
| stem anteversion | a hip lateral radiograph and CT scan were taken to measure stem anteversion Receives: Radiation: Radiological measurement of femoral stem version |
What is being measured
The primary outcome is the main question the study is designed to answer.
stem anteversion of the hip radiograph(decubitus lateral view)
Measured: postoperative 4days
stem anteversion of the CT scan
Measured: postoperative 4days
Secondary outcomes (1)
The correlation between stem anteversion of the decubitus lateral view and stem version of the CT scan
to determine ICC(intraclass coefficient, correlation coefficient)
Measured: postoperative 4days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthroplastyStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kyung-Hoi Koo, Seoul National University Bundang Hospital
- Investigators
- Kyung-Hoi Koo, professor, Principal investigator, Director, Head of Orthopaedics, Seoul National university Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554149
- Sponsor's protocol ID
- Ante-001
- Status last verified
- Mar 2016
- First submitted
- 15 Sep 2015
- Last updated
- 29 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiological Measurement of Femoral Stem Version Using Lateral Decubitus Method: A Prospective Study
- ClinicalTrials.gov ID
- NCT02554149
- Acronym / sponsor ID
- Ante-001
- Conditions
- Arthroplasty, Total Hip Replacement
- Keywords
- total hip, stem version, replacement, hip
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 18 Sep 2015 (estimated)
- 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.
The purpose of this study was to develop a radiological method to measure stem anteversion and to determine its validity and reliability.
Detailed description
Version of the femoral stem is an important factor influencing the risk of dislocation after total hip replacement (THR) as well as the position of the acetabular component. However, there is no radiological method of measuring stem anteversion described in the literature. Investigators propose a radiological method to measure stem version and have assessed its reliability and validity. In 40 patients who underwent THR, a hip radiograph and CT scan were taken to measure stem anteversion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| stem anteversion | – | Radiation: Radiological measurement of femoral stem versiona hip lateral radiograph and CT scan were taken to measure stem anteversion |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients who underwent THR between October 2015 and December 2015
Key inclusion criteria (1 listed)
- Investigators recruited 40 consecutive patients who underwent THR between October 2015 and December 2015
Key exclusion criteria (2 listed)
- patients who could not extend the hip because of a residual flexion contracture.
- who had a flexion contracture of the knee or who could not flex the hip to 90° even after THR were excluded because participants could not adopt the posture required for the particular radiographs and CT scans.
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 |
|---|---|---|
| Radiological measurement of femoral stem versionparticular radiographs( lateral decubitus view) and CT scans | Radiation | stem anteversion |
Primary outcome
stem anteversion of the hip radiograph(decubitus lateral view)
Time frame: postoperative 4days
stem anteversion of the CT scan
Time frame: postoperative 4days
1 secondary outcome
The correlation between stem anteversion of the decubitus lateral view and stem version of the CT scan
Time frame: postoperative 4days
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 29 Mar 2016.
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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.
Kyung-Hoi Koo, professor principal investigator
Director, Head of Orthopaedics, Seoul National university Bundang Hospital
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 Arthroplasty and Total Hip Replacement, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 1 inclusion and 2 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 29 Mar 2016. 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 South Korea. 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?
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?
stem anteversion of the hip radiograph(decubitus lateral view) (time frame: postoperative 4days). The study lists 2 primary outcomes in all. 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 29 Mar 2016.