Degeneration SpineRDSDNCT05332249
Registry for Degenerative Spinal Disease (RDSD)
An observational study of Degeneration Spine and Surgery, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Degeneration Spine, Surgery
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Mar 2021to 30 Dec 2050
- How long will I take part?
- 20 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Adult, Older adult
Study population: Patients who are going to take surgery at Seoul National University Hospital.
Who may be able to join
- Degenerative lumbar spinal disease.
- Degenerative Cervical spinal disease
Who cannot join
- combined progressive cancer disease
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Korea, 03080
Chi Heon Kim, Pf., +82-2-2072-2358, chiheon1@snu.ac.kr
About this study
Official title: 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.
Read the 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.
- Conditions
- Degeneration Spine, Surgery
- Being tested
- Surgery
- Keywords
- Spine, Outcomes, Degeneration spine, Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Patients who undergo spinal surgery for degenerative spinal disease
| Study group | Role | What they receive |
|---|---|---|
| Lumbar | Patients undergo lumbar spinal surgery for degenerative lumbar spinal disease. Receives: Procedure: Surgery | |
| Cervical | Patients undergo cervical spinal surgery for degenerative cervical spinal disease. Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability index
Improve of disability index more than 30% from the baseline
Measured: 20 years
Secondary outcomes (2)
C7-sagittal vertical axis (C7-SVA)
Change of C7-SVA, quantative comparison between preoperation and postoperative year 20 years.
Measured: 20 years
European quality of life questionnare _ 5 dimension (EQ-5D)
Improve of EQ-5D more than 30% from the baseline
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2022
- Study start8 Mar 2021
- Primary completion30 Dec 2050 (estimated)
- Study completion30 Dec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Degeneration SpineStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 20 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chi Heon Kim, pf., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05332249
- Sponsor's protocol ID
- Degenerative registry
- Acronym
- RDSD
- Status last verified
- Apr 2024
- First submitted
- 1 Mar 2022
- Last updated
- 22 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No