Registry for Degenerative Spinal Disease (RDSD)

Surgery Clinical Trial

— RDSD  

Official title:

Registry for Degenerative Spinal Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05332249
• Other study ID #: Degenerative registry
• Status: Recruiting
• Start date: March 8, 2021
• Est. completion date: December 30, 2050

Study information

• Verified date: April 2024
• Source: Seoul National University Hospital
• Contact: Chi Heon Kim, Pf.
• Phone: +82-2-2072-2358
• Email: chiheon1[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: December 30, 2050
• Est. primary completion date: December 30, 2050
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

Inclusion Criteria:

• Degenerative lumbar spinal disease.
• Degenerative Cervical spinal disease

Exclusion Criteria:

• combined progressive cancer disease

Related Conditions & MeSH terms

• Degeneration Spine
• Spinal Diseases
• Surgery

Intervention

Procedure:
• Surgery
Patients who undergo spinal surgery for degenerative spinal disease

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul	Korea

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disability index	Improve of disability index more than 30% from the baseline	20 years
Secondary	C7-sagittal vertical axis (C7-SVA)	Change of C7-SVA, quantative comparison between preoperation and postoperative year 20 years.	20 years
Secondary	European quality of life questionnare _ 5 dimension (EQ-5D)	Improve of EQ-5D more than 30% from the baseline	20 years