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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Registry for Degenerative Spinal Disease
- ClinicalTrials.gov ID
- NCT05332249
- Acronym / sponsor ID
- RDSD / Degenerative registry
- Conditions
- Degeneration Spine, Surgery
- Keywords
- Spine, Outcomes, Degeneration spine, Surgery
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 30 Dec 2050 (estimated)
- Study completion
- 30 Dec 2050 (estimated)
- First posted
- 18 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 20 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lumbar | – | Procedure: SurgeryPatients undergo lumbar spinal surgery for degenerative lumbar spinal disease. |
| Cervical | – | Procedure: SurgeryPatients undergo cervical spinal surgery for degenerative cervical spinal disease. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who are going to take surgery at Seoul National University Hospital.
Key inclusion criteria (2 listed)
- Degenerative lumbar spinal disease.
- Degenerative Cervical spinal disease
Key exclusion criteria (1 listed)
- combined progressive cancer disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryPatients who undergo spinal surgery for degenerative spinal disease | Procedure or surgery | Cervical, Lumbar |
Primary outcome
Disability index
Time frame: 20 years
Improve of disability index more than 30% from the baseline
2 secondary outcomes
C7-sagittal vertical axis (C7-SVA)
Time frame: 20 years
European quality of life questionnare _ 5 dimension (EQ-5D)
Time frame: 20 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
- Individual participant dataSharing planned: No
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Prognostic Factors in Zygapophyseal Osteoarthritis Infiltration: a Prospective Cohort Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chi Heon Kim, pf. principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Degeneration Spine and Surgery, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chi Heon Kim, Pf. (+82-2-2072-2358, chiheon1@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability index (time frame: 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.