NCT05332249

Brief Summary

The outcome after spinal surgery is important and the evidence is critical to develop treatment. The purpose of this study is to make a prospective registry of database for further research.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
300mo left

Started Mar 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 Progress17%
Mar 2021Dec 2050

Study Start

First participant enrolled

March 8, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 18, 2022

Completed
28.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2050

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2050

Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

29.8 years

First QC Date

March 1, 2022

Last Update Submit

April 18, 2024

Conditions

Degeneration SpineSurgery

Keywords

SpineOutcomesDegeneration spineSurgery

Outcome Measures

Primary Outcomes (1)

  • Disability index

    Improve of disability index more than 30% from the baseline

    20 years

Secondary Outcomes (2)

  • C7-sagittal vertical axis (C7-SVA)

    20 years

  • European quality of life questionnare _ 5 dimension (EQ-5D)

    20 years

Study Arms (2)

Lumbar

Patients undergo lumbar spinal surgery for degenerative lumbar spinal disease.

Procedure: Surgery

Cervical

Patients undergo cervical spinal surgery for degenerative cervical spinal disease.

Procedure: Surgery

Interventions

SurgeryPROCEDURE

Patients who undergo spinal surgery for degenerative spinal disease

CervicalLumbar

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are going to take surgery at Seoul National University Hospital.

You may qualify if:

  • Degenerative lumbar spinal disease.
  • Degenerative Cervical spinal disease

You may not qualify if:

  • combined progressive cancer disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Korea, 03080, South Korea

RECRUITING

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Officials

  • Chi Heon Kim, pf.

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi Heon Kim, Pf.

CONTACT

+82-2-2072-2358chiheon1@snu.ac.kr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
20 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2022

First Posted

April 18, 2022

Study Start

March 8, 2021

Primary Completion (Estimated)

December 30, 2050

Study Completion (Estimated)

December 30, 2050

Last Updated

April 22, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)