Hip FracturesNCT03182608
Ultrasound Assessment of the Anatomic Landmarks for Spinal Anesthesia in Patients With Hip Fracture
A study testing Noninvasive ultrasound assessment in people with Hip Fractures, run by SMG-SNU Boramae Medical Center at 1 site in South Korea.
Trial summary
Investigators assess the anatomic landmarks for spinal anesthesia in patients with hip fracture using ultrasonography. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fractures
- What is being tested?
- Noninvasive ultrasound assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Jun 2017to 31 Mar 2018
- Phase
- Interventional
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients scheduled for hip fracture surgery under spinal anesthesia
Who cannot join
- Anatomic abnormalities or masses in the spine
- History of spinal surgery of compression fracture
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 156-707
About this study
Investigators assess the anatomic landmarks for spinal anesthesia in patients with hip fracture using ultrasonography.
Read the detailed description
Investigators evaluate the anatomic landmarks using Tuffier's line and the tenth rib line for spinal anesthesia in patients with hip fracture, and then assess the consistency of the landmarks-guided interspinous levels with the actual interspinous level using ultrasonography.
- Conditions
- Hip Fractures
- Being tested
- Noninvasive ultrasound assessment
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Noninvasive ultrasound assessmentDiagnostic test
An investigator evaluate the L4-5 interspinous level using anatomic landmarks in turn, then another independent investigator assess the consistency of the landmarks-guided interspinous level with the actual one by noninvasive ultrasound assessment.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | In the lateral decubitus position, an investigator evaluate the L4-5 interspinous level using an anatomic landmark (Tuffier's line), and then evaluate the L4-5 interspinous level using another anatomic landmark (Tenth rib line). Another investigator evaluate the actual L4-5 interspinous level by noninvasive ultrasonography. Receives: Diagnostic Test: Noninvasive ultrasound assessment |
| Group 2 | Experimental | In the lateral decubitus position, an investigator evaluate the L4-5 interspinous level using an anatomic landmark (Tenth rib line), and then evaluate the L4-5 interspinous level using another anatomic landmark (Tuffier's line). Another investigator evaluate the actual L4-5 interspinous level by noninvasive ultrasonography. Receives: Diagnostic Test: Noninvasive ultrasound assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of each anatomic landmark (Tuffier's line and tenth rib line).
Actual interspinous levels of the landmark-guided approches (Tuffier's line and tenth rib line) are assessed using ultrasonography.
Measured: Baseline
Secondary outcomes (1)
The estimation ratio related to the intervertebral levels
Actual interspinous levels of the landmark-guided approches (Tuffier's line and tenth rib line) are assessed using ultrasonography.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2017
- Study start9 Jun 2017
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- SMG-SNU Boramae Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Young Hwang, SMG-SNU Boramae Medical Center
- Investigators
- Jin-Young Hwang, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03182608
- Sponsor's protocol ID
- 16-2017-46
- Status last verified
- Apr 2018
- First submitted
- 26 May 2017
- Last updated
- 3 Apr 2018
- Results posted
- No
- 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 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Assessment of the Anatomic Landmarks for Spinal Anesthesia in Patients With Hip Fracture
- ClinicalTrials.gov ID
- NCT03182608
- Acronym / sponsor ID
- 16-2017-46
- Conditions
- Hip Fractures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- SMG-SNU Boramae Medical CenterUniversity, hospital or other
- Study start
- 9 Jun 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 9 Jun 2017 (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.
Investigators assess the anatomic landmarks for spinal anesthesia in patients with hip fracture using ultrasonography.
Detailed description
Investigators evaluate the anatomic landmarks using Tuffier's line and the tenth rib line for spinal anesthesia in patients with hip fracture, and then assess the consistency of the landmarks-guided interspinous levels with the actual interspinous level using ultrasonography.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Crossover
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Diagnostic Test: Noninvasive ultrasound assessmentIn the lateral decubitus position, an investigator evaluate the L4-5 interspinous level using an anatomic landmark (Tuffier's line), and then evaluate the L4-5 interspinous level using another anatomic landmark (Tenth rib line). Another investigator evaluate the actual L4-5 interspinous level by noninvasive ultrasonography. |
| Group 2 | Experimental | Diagnostic Test: Noninvasive ultrasound assessmentIn the lateral decubitus position, an investigator evaluate the L4-5 interspinous level using an anatomic landmark (Tenth rib line), and then evaluate the L4-5 interspinous level using another anatomic landmark (Tuffier's line). Another investigator evaluate the actual L4-5 interspinous level by noninvasive ultrasonography. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for hip fracture surgery under spinal anesthesia
Key exclusion criteria (2 listed)
- Anatomic abnormalities or masses in the spine
- History of spinal surgery of compression fracture
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 |
|---|---|---|
| Noninvasive ultrasound assessmentAn investigator evaluate the L4-5 interspinous level using anatomic landmarks in turn, then another independent investigator assess the consistency of the landmarks-guided interspinous level with the actual one by noninvasive ultrasound assessment. | Diagnostic test | Group 1, Group 2 |
Primary outcome
Accuracy of each anatomic landmark (Tuffier's line and tenth rib line).
Time frame: Baseline
Actual interspinous levels of the landmark-guided approches (Tuffier's line and tenth rib line) are assessed using ultrasonography.
1 secondary outcome
The estimation ratio related to the intervertebral levels
Time frame: Baseline
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 3 Apr 2018.
- Individual participant dataSharing planned: No
Related trials for Hip Fractures
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Not yet recruiting
A Decision Support Tool for Common Surgical Fixations of Hip Fractures
Hip Fracture Surgeries, High Risk Population of Hip Fractures
Enrolling by invitationObservational study
GRACE II (General Retrospective Analysis of Commercial Experience With AGN1 LOEP)
Osteoporosis
Recruiting
Monitored Anesthesia Care and Soft Tissue Infiltration With Local Anesthesia Feasibility Trial
Hip Fracture Surgeries, Intertrochanteric Fracture
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.
Jin-Young Hwang principal investigator
SMG-SNU Boramae Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Noninvasive ultrasound assessment in people with Hip Fractures, run by SMG-SNU Boramae Medical Center 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 3 Apr 2018. 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?
Accuracy of each anatomic landmark (Tuffier's line and tenth rib line). (time frame: Baseline). 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 Apr 2018; AzTrials last refreshed its copy on 7 Nov 2026.