NCT04891432

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2021

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 8, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 13, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 18, 2021

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

April 19, 2024

Status Verified

April 1, 2024

Enrollment Period

4.7 years

First QC Date

May 13, 2021

Last Update Submit

April 18, 2024

Conditions

Fusion of SpineSympathetic Nervous System

Outcome Measures

Primary Outcomes (1)

  • 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

    Postoperative day one

Secondary Outcomes (1)

  • Other complications

    Postoperative 6 month

Interventions

Lateral lumbar interbody fusionPROCEDURE

oblique lumbar interbody fusion or direct lateral interbody fusion

Also known as: front versus back sympathetic chain approach

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with lumbar degenerative disease

You may qualify if:

  • Patients with lumbar degenerative disease needs a lateral lumbar interbody fusion of 1-2 segments between L2 to S1.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Korea, 03080, South Korea

RECRUITING

Central Study Contacts

Chi Heon Kim, MD

CONTACT

+82-2-2072-3398chiheon1@snu.ac.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 13, 2021

First Posted

May 18, 2021

Study Start

April 8, 2021

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

April 19, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)