Total Knee ArthroplastyNCT05382507
The Ultrasonographic Measurement of Quadriceps Muscle Thickness and the Shape of the Femoral Nerve in Patients Undergoing Total Knee Arthroplasty: an Observational Study
An observational study of Total Knee Arthroplasty, run by Yonsei University at 1 site in South Korea.
Trial summary
For each individual, the femoral nerve shows various shapes and locations. This is because the femoral nerve is located on top of the iliacus muscle, so the shape and location of the femoral nerve seems to be related to the patient's muscle mass. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Total Knee Arthroplasty
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2022to Mar 2024
- 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 19 years and older
- All sexes
- Adult, Older adult
Study population: patients undergoing total knee arthroplasty
Who may be able to join
- 1. Patients aged 19 years old or older and scheduled for elective total knee arthroplasty
Who cannot join
- 1. Pre-existing neurologic or anatomic deficits in the lower extremities
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei University Health System, Severance Hospital
Seoul, Seodaemun-gu
Bora Lee, 82-2-2224-3919, dreamkaist@yuhs.ac
About this study
For each individual, the femoral nerve shows various shapes and locations. This is because the femoral nerve is located on top of the iliacus muscle, so the shape and location of the femoral nerve seems to be related to the patient's muscle mass. Ultrasound of the quadriceps femoris could represent a widely available, non-invasive, affordable, and reliable tool to evaluate skeletal muscle. We aim to investigate the relationship between muscle mass and the shape of the femoral nerve through this observational study.
- Conditions
- Total Knee Arthroplasty
What is being measured
The primary outcome is the main question the study is designed to answer.
the thickness of rectus femoralis and vastus intermedius, the shape of the femoral nerve
Assessment of quadriceps femoris thickness using ultrasound. Thickness of each muscle is measured from the femur to the inner edge of the vastus intermedius (VI) muscle, or from subcutaneous tissue to the inner edge of the rectus femoris (RF) muscle. The shape of the femoral nerve was measured by ultrasound.
Measured: preoperative (about 10 minutes before entering the operating room)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study startMay 2022 (estimated)
- Primary completionMar 2024 (estimated)
- Study completionMar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bora Lee, Principal investigator, Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382507
- Sponsor's protocol ID
- 4-2022-0229
- Status last verified
- May 2022
- First submitted
- 15 May 2022
- Last updated
- 27 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ultrasonographic Measurement of Quadriceps Muscle Thickness and the Shape of the Femoral Nerve in Patients Undergoing Total Knee Arthroplasty: an Observational Study
- ClinicalTrials.gov ID
- NCT05382507
- Acronym / sponsor ID
- 4-2022-0229
- Conditions
- Total Knee Arthroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Mar 2024 (estimated)
- Study completion
- Mar 2024 (estimated)
- First posted
- 19 May 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.
For each individual, the femoral nerve shows various shapes and locations. This is because the femoral nerve is located on top of the iliacus muscle, so the shape and location of the femoral nerve seems to be related to the patient's muscle mass. Ultrasound of the quadriceps femoris could represent a widely available, non-invasive, affordable, and reliable tool to evaluate skeletal muscle. We aim to investigate the relationship between muscle mass and the shape of the femoral nerve through this observational study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients undergoing total knee arthroplasty
Key inclusion criteria (1 listed)
- 1. Patients aged 19 years old or older and scheduled for elective total knee arthroplasty
Key exclusion criteria (1 listed)
- 1. Pre-existing neurologic or anatomic deficits in the lower extremities
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
the thickness of rectus femoralis and vastus intermedius, the shape of the femoral nerve
Time frame: preoperative (about 10 minutes before entering the operating room)
Assessment of quadriceps femoris thickness using ultrasound. Thickness of each muscle is measured from the femur to the inner edge of the vastus intermedius (VI) muscle, or from subcutaneous tissue to the inner edge of the rectus femoris (RF) muscle. The shape of the femoral nerve was measured by ultrasound.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2022.
- Individual participant dataSharing planned: No
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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.
Bora Lee principal investigator
Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
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 Total Knee Arthroplasty, run by Yonsei University 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 1 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 27 May 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bora Lee (82-2-2224-3919, dreamkaist@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the thickness of rectus femoralis and vastus intermedius, the shape of the femoral nerve (time frame: preoperative (about 10 minutes before entering the operating room)). 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 27 May 2022.