Fusion of SpineNCT04891432
Comparison of Surgical Outcomes Between Pre Sympathetic Plexus and Post Sympathetic Plexus Approach
An observational study of Fusion of Spine and Sympathetic Nervous System, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
There would be no difference in the risk of sympathetic plexus damage between the pre sympathetic plexus approach and the post sympathetic plexus approach. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Fusion of Spine, Sympathetic Nervous System
- What is being tested?
- Lateral lumbar interbody fusion
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Apr 2021to 31 Dec 2025
- How long will I take part?
- 6 Months
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with lumbar degenerative disease
Who may be able to join
- Patients with lumbar degenerative disease needs a lateral lumbar interbody fusion of 1-2 segments between L2 to S1.
Who cannot join
- Patients who had previously had lumbar surgery
- Patients with muscle weakness of motor grade III or lower
- Patients with neuropsychiatric diseases such as depression
- Patients with musculoskeletal disease, inflammatory musculoskeletal disease, or infection
- Patients with cancerous disease
- Patients who do not want to participate in the study
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Korea, 03080
Seoul National U Hospital, 22072358, chiheon1@snu.ac.kr
About this study
There would be no difference in the risk of sympathetic plexus damage between the pre sympathetic plexus approach and the post sympathetic plexus approach.
Read the detailed description
Compare the incidence of sympathetic chain injury between front and back of sympathetic approach in oblique lumbar interbody fusion
- Conditions
- Fusion of Spine, Sympathetic Nervous System
- Being tested
- Lateral lumbar interbody fusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lateral lumbar interbody fusionProcedure or surgery
Also called front versus back sympathetic chain approach
oblique lumbar interbody fusion or direct lateral interbody fusion
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of sympathetic plexus injury
The number of patiensts with sympathetic symptom such as edema of the lower extremity, change of skin temperature, pain, or paresthesia without other medical conditions
Measured: Postoperative day one
Secondary outcomes (1)
Other complications
the number of patients with any other complication such as Injury of vascular structure, ureter, peritoneum, or bowel.
Measured: Postoperative 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start8 Apr 2021
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fusion of SpineStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi Heon Kim, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04891432
- Sponsor's protocol ID
- 2101-142-1191
- Status last verified
- Apr 2024
- First submitted
- 13 May 2021
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- 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 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Surgical Outcomes Between Pre Sympathetic Plexus and Post Sympathetic Plexus Approach
- ClinicalTrials.gov ID
- NCT04891432
- Acronym / sponsor ID
- 2101-142-1191
- Conditions
- Fusion of Spine, Sympathetic Nervous System
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 8 Apr 2021 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 May 2021 (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.
There would be no difference in the risk of sympathetic plexus damage between the pre sympathetic plexus approach and the post sympathetic plexus approach.
Detailed description
Compare the incidence of sympathetic chain injury between front and back of sympathetic approach in oblique lumbar interbody fusion
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with lumbar degenerative disease
Key inclusion criteria (1 listed)
- Patients with lumbar degenerative disease needs a lateral lumbar interbody fusion of 1-2 segments between L2 to S1.
Key exclusion criteria (6 listed)
- Patients who had previously had lumbar surgery
- Patients with muscle weakness of motor grade III or lower
- Patients with neuropsychiatric diseases such as depression
- Patients with musculoskeletal disease, inflammatory musculoskeletal disease, or infection
- Patients with cancerous disease
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 |
|---|---|---|
| Lateral lumbar interbody fusionAlso: front versus back sympathetic chain approachoblique lumbar interbody fusion or direct lateral interbody fusion | Procedure or surgery | – |
Primary outcome
The rate of sympathetic plexus injury
Time frame: Postoperative day one
The number of patiensts with sympathetic symptom such as edema of the lower extremity, change of skin temperature, pain, or paresthesia without other medical conditions
1 secondary outcome
Other complications
Time frame: Postoperative 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- 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.
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 Fusion of Spine and Sympathetic Nervous System, 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 1 inclusion and 6 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 19 Apr 2024. 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 Chi Heon Kim, MD (+82-2-2072-3398, chiheon1@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of sympathetic plexus injury (time frame: Postoperative day one). 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 19 Apr 2024.