Knee OsteoarthritisNCT05327413
Femoral External Rotation Measured on CT and MRI
An observational study of Knee Osteoarthritis, run by The Affiliated Hospital of Qingdao University at 1 site in China.
Trial summary
This study aims to compare the femoral external rotation measured on CT and MRI to that measured intraoperatively to clarify the influence of residual cartilage on posterior condyle on the preoperative planning of total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- CT and MRI
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 31 Dec 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients underwent TKA due to knee arthroplasty (Kellgren-Lawrence Grade III or IV)
Who may be able to join
- 50-85 years old
- patients with osteoarthritis (Kellgren-Lawrence Grade III or IV) underwent total knee arthroplasty.
Who cannot join
- patients cannot endure TKA due to severe heart failure, arrhythmia, myocardial infarction, infection or other reason.
- patients who cannot undergo MRI.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The affiliated hospital of Qingdao University
Qingdao, Shandong
Jie Zhu, M.D., +86-0532-82911869, 15169093669@163.com
Shuai Xiang, M.D.
About this study
Official title: A Prospective Cohort Study to Compare the Accuracy of Femoral External Rotation Measured on CT and MRI
This study aims to compare the femoral external rotation measured on CT and MRI to that measured intraoperatively to clarify the influence of residual cartilage on posterior condyle on the preoperative planning of total knee arthroplasty.
- Conditions
- Knee Osteoarthritis
- Being tested
- CT and MRI
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT and MRIOther
CT and MRI were conducted to measure the femoral external rotation
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Not described Receives: Other: CT and MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Femoral external rotation on CT
the angel between the posterior condylar axis (PCA) and transepicondylar axis (TEA) on CT
Measured: Preoperative
Femoral external rotation on MRI
the angel between the posterior condylar axis (PCA) and transepicondylar axis (TEA) on MRI
Measured: Preoperative
Intraoperative femoral external rotation
the angel between the posterior condylar axis (PCA) and transepicondylar axis (TEA) measured intraoperatively
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2022
- Study start1 Apr 2022
- Primary completion30 Sep 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by The Affiliated Hospital of Qingdao 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Qingdao University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, xiangshuai, The Affiliated Hospital of Qingdao University
- Investigators
- Shuai Xiang, Principal investigator, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05327413
- Sponsor's protocol ID
- QYFYKYLL 915211920
- Status last verified
- Apr 2022
- First submitted
- 7 Apr 2022
- Last updated
- 21 Apr 2022
- 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 21 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study to Compare the Accuracy of Femoral External Rotation Measured on CT and MRI
- ClinicalTrials.gov ID
- NCT05327413
- Acronym / sponsor ID
- QYFYKYLL 915211920
- Conditions
- Knee Osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Qingdao UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 14 Apr 2022 (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 aims to compare the femoral external rotation measured on CT and MRI to that measured intraoperatively to clarify the influence of residual cartilage on posterior condyle on the preoperative planning of total knee arthroplasty.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: CT and MRI |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients underwent TKA due to knee arthroplasty (Kellgren-Lawrence Grade III or IV)
Key inclusion criteria (2 listed)
- 50-85 years old
- patients with osteoarthritis (Kellgren-Lawrence Grade III or IV) underwent total knee arthroplasty.
Key exclusion criteria (2 listed)
- patients cannot endure TKA due to severe heart failure, arrhythmia, myocardial infarction, infection or other reason.
- patients who cannot undergo MRI.
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 |
|---|---|---|
| CT and MRICT and MRI were conducted to measure the femoral external rotation | Other | Group 1 |
Primary outcome
Femoral external rotation on CT
Time frame: Preoperative
the angel between the posterior condylar axis (PCA) and transepicondylar axis (TEA) on CT
Femoral external rotation on MRI
Time frame: Preoperative
the angel between the posterior condylar axis (PCA) and transepicondylar axis (TEA) on MRI
Intraoperative femoral external rotation
Time frame: Intraoperative
the angel between the posterior condylar axis (PCA) and transepicondylar axis (TEA) measured intraoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2022.
- 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.
Shuai Xiang principal investigator
The Affiliated Hospital of Qingdao 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 Knee Osteoarthritis, run by The Affiliated Hospital of Qingdao University 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 2 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: status not confirmed, as of the sponsor's last update on 21 Apr 2022. 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?
Contact Jie Zhu (0532-82911869, 15169093669@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Femoral external rotation on CT (time frame: Preoperative). The study lists 3 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 21 Apr 2022.