Registry for Degenerative Spinal Disease (RDSD) (RDSD)

Registry for Degenerative Spinal Disease

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.

Study Overview

• Status: Recruiting
• Conditions: Surgery; Degeneration Spine
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Chi Heon Kim, Pf.; Phone Number: +82-2-2072-2358; Email: chiheon1@snu.ac.kr

Study Locations

• Korea, Republic of
  • Korea
    • Seoul, Korea, Korea, Republic of, 03080
      • Recruiting
      • Seoul National University Hospital
      • Contact: Chi Heon Kim, Pf.; Phone Number: +82-2-2072-2358; Email: chiheon1@snu.ac.kr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• Degenerative lumbar spinal disease.
• Degenerative Cervical spinal disease

Exclusion Criteria:

• combined progressive cancer disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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)	Improve of EQ-5D more than 30% from the baseline	20 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 8, 2021
• Primary Completion (Estimated): December 30, 2050
• Study Completion (Estimated): December 30, 2050

Study Registration Dates

• First Submitted: March 1, 2022
• First Submitted That Met QC Criteria: April 10, 2022
• First Posted (Actual): April 18, 2022

Study Record Updates

• Last Update Posted (Actual): April 22, 2024
• Last Update Submitted That Met QC Criteria: April 18, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Surgery; Outcomes; Spine; Degeneration spine
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Spinal Diseases
• Other Study ID Numbers: Degenerative registry

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No