Registry for Degenerative Spinal Disease (RDSD)

Sponsor

Seoul National University Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05332249

Collaborator

(none)

5,000

Enrollment

Location

357.7

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Degeneration Spine Surgery	Procedure: Surgery

Detailed Description

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.

Included patients Degenerative cervical spinal disease. Degenerative lumbar spinal disease.

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

5000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Registry for Degenerative Spinal Disease

Actual Study Start Date :

Mar 8, 2021

Anticipated Primary Completion Date :

Dec 30, 2050

Anticipated Study Completion Date :

Dec 30, 2050

Arms and Interventions

Arm	Intervention/Treatment
Lumbar Patients undergo lumbar spinal surgery for degenerative lumbar spinal disease.	Procedure: Surgery Patients who undergo spinal surgery for degenerative spinal disease
Cervical Patients undergo cervical spinal surgery for degenerative cervical spinal disease.	Procedure: Surgery Patients who undergo spinal surgery for degenerative spinal disease

Arm

Intervention/Treatment

Lumbar

Patients undergo lumbar spinal surgery for degenerative lumbar spinal disease.

Procedure: Surgery

Patients who undergo spinal surgery for degenerative spinal disease

Cervical

Patients undergo cervical spinal surgery for degenerative cervical spinal disease.

Procedure: Surgery

Patients who undergo spinal surgery for degenerative spinal disease

Outcome Measures

Primary Outcome Measures

Disability index [20 years]
Improve of disability index more than 30% from the baseline

Secondary Outcome Measures

C7-sagittal vertical axis (C7-SVA) [20 years]
Change of C7-SVA, quantative comparison between preoperation and postoperative year 20 years.
European quality of life questionnare _ 5 dimension (EQ-5D) [20 years]
Improve of EQ-5D more than 30% from the baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Inclusion Criteria:

Degenerative lumbar spinal disease.
Degenerative Cervical spinal disease

Exclusion Criteria:

combined progressive cancer disease

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul	Korea	Korea, Republic of	03080

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator: Chi Heon Kim, pf., Seoul National University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT05332249

Other Study ID Numbers:

Degenerative registry

First Posted:

Apr 18, 2022

Last Update Posted:

Apr 18, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Seoul National University Hospital

Additional relevant MeSH terms:

Spinal Diseases

Study Results

No Results Posted as of Apr 18, 2022