SpondylolisthesisNCT04426916
Spine Ultrasound Image Study of Spondylolisthesis Patient
An observational study of Spondylolisthesis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study is to evaluate the anatomical characteristics of spondylolisthesis patients using spine ultrasound imaging. The optimal angle of spinal needle insertion for spinal anesthesia in spondylolisthesis patients was compared to that of normal patients without abnormal spinal anatomy. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Spondylolisthesis
- What is being tested?
- Spondylolisthesis
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Jun 2020to 7 Aug 2020
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients scheduled for elective orthopedic surgery in SNUH(Seoul national university hospital) with ASA physical status classification system I, II, III.
Who may be able to join
- Adult patients scheduled for elective orthopedic surgery.
- with ASA physical status classification system I, II, III.
Who cannot join
- Patients with communication difficulties.
- Patient who can not take a lateral decubitus position for spinal anesthesia. (e.g) fracture)
- Patients with a medical history of spinal surgery.
- Patients with significant spinal anatomical deformity any other than spondylolisthesis. (for spondylolisthesis patients group)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Image Study to Evaluate the Optimal Angulation of Needle Insertion for Spinal Anesthesia in Patients With Spondylolisthesis
This study is to evaluate the anatomical characteristics of spondylolisthesis patients using spine ultrasound imaging. The optimal angle of spinal needle insertion for spinal anesthesia in spondylolisthesis patients was compared to that of normal patients without abnormal spinal anatomy.
- Conditions
- Spondylolisthesis
- Being tested
- Spondylolisthesis
- Keywords
- optimal angle
- Medical subject headings
- Spondylolisthesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpondylolisthesisOther
Spondylolisthesis at a single level
| Study group | Role | What they receive |
|---|---|---|
| normal lumbar spine | Patient without spondylolisthesis or significant spinal anatomic deformity. (ex> severe spondylosis, spinal stenosis, scoliosis, etc..) | |
| spondylolisthesis | Spondylolisthesis patients, with whom the deformity is at just one level. The patients should not have any other significant spinal deformity. (ex> severe spondylosis, spinal stenosis, scoliosis, etc..) Receives: Other: Spondylolisthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
The predicted optimal angle of spinal needle insertion for spinal anesthesia at the level of spondylolisthesis. (alpha 1)
The needle insertion angle where the height of ligamentum flavum/dura mater complex(LFD) is measured the longest in ultrasound image.
Measured: Preanesthesia
The predicted optimal angle of spinal needle insertion for spinal anesthesia at the one upper level of spondylolisthesis. (alpha 2)
The needle insertion angle where the height of LFD is measured the longest in ultrasound image.
Measured: Preanesthesia
Secondary outcomes (4)
The height of LFD measured by ultrasound image.
The height of LFD at the interlaminar space in midline and paramedian ultrasonography view at the angle of alpha 1 \& alpha 2.
Measured: Preanesthesia
The depth from skin (needle insertion point) to LFD.
The depth from skin to LFD at the interlaminar space in midline and paramedian ultrasonography view at the angle of alpha 1 \& alpha 2.
Measured: Preanesthesia
The depth from skin (needle insertion point) to posterior longitudinal ligament(PLL).
The depth from skin to PLL at the interlaminar space in midline and paramedian ultrasonography view at the angle of alpha 1 \& alpha 2.
Measured: Preanesthesia
Patients' gender, age, height, weight, BMI, etc.
gender, age, height, weight, BMI
Measured: Preanesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start23 Jun 2020
- Primary completion6 Aug 2020
- Study completion7 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SpondylolisthesisStudies of the same condition, open and under way.
- More trials run by Seoul National University 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426916
- Sponsor's protocol ID
- H-2005-149-1125
- Status last verified
- Jan 2021
- First submitted
- 8 Jun 2020
- Last updated
- 7 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kim Y, Yoo S, Park SK, Bae H, Lim YJ, Kim JT. Optimal angle of needle insertion for spinal anesthesia in patients with spondylolisthesis: an ultrasonographic study. BMC Anesthesiol. 2021 Sep 8;21(1):221. doi: 10.1186/s12871-021-01444-0.
PubMed 34496754
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Image Study to Evaluate the Optimal Angulation of Needle Insertion for Spinal Anesthesia in Patients With Spondylolisthesis
- ClinicalTrials.gov ID
- NCT04426916
- Acronym / sponsor ID
- H-2005-149-1125
- Conditions
- Spondylolisthesis
- Keywords
- optimal angle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 23 Jun 2020 (actual)
- Primary completion
- 6 Aug 2020 (actual)
- Study completion
- 7 Aug 2020 (actual)
- First posted
- 11 Jun 2020 (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 is to evaluate the anatomical characteristics of spondylolisthesis patients using spine ultrasound imaging. The optimal angle of spinal needle insertion for spinal anesthesia in spondylolisthesis patients was compared to that of normal patients without abnormal spinal anatomy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| normal lumbar spine | – | –Patient without spondylolisthesis or significant spinal anatomic deformity. (ex> severe spondylosis, spinal stenosis, scoliosis, etc..) |
| spondylolisthesis | – | Other: SpondylolisthesisSpondylolisthesis patients, with whom the deformity is at just one level. The patients should not have any other significant spinal deformity. (ex> severe spondylosis, spinal stenosis, scoliosis, etc..) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients scheduled for elective orthopedic surgery in SNUH(Seoul national university hospital) with ASA physical status classification system I, II, III.
Key inclusion criteria (2 listed)
- Adult patients scheduled for elective orthopedic surgery.
- with ASA physical status classification system I, II, III.
Key exclusion criteria (4 listed)
- Patients with communication difficulties.
- Patient who can not take a lateral decubitus position for spinal anesthesia. (e.g) fracture)
- Patients with a medical history of spinal surgery.
- Patients with significant spinal anatomical deformity any other than spondylolisthesis. (for spondylolisthesis patients group)
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 |
|---|---|---|
| SpondylolisthesisSpondylolisthesis at a single level | Other | spondylolisthesis |
Primary outcome
The predicted optimal angle of spinal needle insertion for spinal anesthesia at the level of spondylolisthesis. (alpha 1)
Time frame: Preanesthesia
The needle insertion angle where the height of ligamentum flavum/dura mater complex(LFD) is measured the longest in ultrasound image.
The predicted optimal angle of spinal needle insertion for spinal anesthesia at the one upper level of spondylolisthesis. (alpha 2)
Time frame: Preanesthesia
The needle insertion angle where the height of LFD is measured the longest in ultrasound image.
4 secondary outcomes
The height of LFD measured by ultrasound image.
Time frame: Preanesthesia
The depth from skin (needle insertion point) to LFD.
Time frame: Preanesthesia
The depth from skin (needle insertion point) to posterior longitudinal ligament(PLL).
Time frame: Preanesthesia
Patients' gender, age, height, weight, BMI, etc.
Time frame: Preanesthesia
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 7 Jan 2021.
- Derived from this study: PubMed 34496754Kim Y, Yoo S, Park SK, Bae H, Lim YJ, Kim JT. Optimal angle of needle insertion for spinal anesthesia in patients with spondylolisthesis: an ultrasonographic study. BMC Anesthesiol. 2021 Sep 8;21(1):221. doi: 10.1186/s12871-021-01444-0.
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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.
Jin-Tae Kim, MD, PhD principal investigator
Seoul National University 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 Spondylolisthesis, run by Seoul National University 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 2 inclusion and 4 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 7 Jan 2021. 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?
The predicted optimal angle of spinal needle insertion for spinal anesthesia at the level of spondylolisthesis. (alpha 1) (time frame: Preanesthesia). 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?
On the ClinicalTrials.gov record for NCT04426916, which also lists 1 linked publication.
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 7 Jan 2021.