Registry for Degenerative Spinal Disease (RDSD) | NCT05332249

Studies
Registry for Degenerative Spinal Disease (RDSD)

NCT05332249

Sponsor

Seoul National University Hospital

Status

Recruiting

Last Update Posted

Apr 22, 2024Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Degeneration Spine
Surgery

Interventions

Surgery

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 8, 2021Actual

Primary Completion Date

Dec 30, 2050Estimated

Completion Date

Dec 30, 2050Estimated

First Submitted Date

Mar 1, 2022

First Submission Date that Met QC Criteria

Apr 10, 2022

First Posted Date

Apr 18, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2024

Last Update Posted Date

Apr 22, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

20 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Surgery	Procedure	Patients who undergo spinal surgery for degenerative spinal disease	Cervical Lumbar

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Disability index	Improve of disability index more than 30% from the baseline	20 years

Secondary Outcomes

Measure	Description	Time Frame
C7-sagittal vertical axis (C7-SVA)	Change of C7-SVA, quantative comparison between preoperation and postoperative year 20 years.	20 years
European quality of life questionnare _ 5 dimension (EQ-5D)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Degenerative lumbar spinal disease.
Degenerative Cervical spinal disease

Exclusion Criteria:

combined progressive cancer disease

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chi Heon Kim, Pf.	Contact	+82-2-2072-2358		chiheon1@snu.ac.kr

Overall Officials

Name	Affiliation	Role
Chi Heon Kim, pf.	Seoul National University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital	Recruiting	Seoul	Korea	03080	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013514	Surgical Procedures, Operative

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided