Spinal Fusion2nd ACDFNCT03826329
Risk Factors of Second Surgery for Adjacent Segment Disease Following Anterior Cervical Discectomy and Fusion
An observational study of Spinal Fusion, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Although the incidence of second surgery for adjacent segment disease (ASD) after anterior cervical discectomy and fusion (ACDF) has been reported, its risk factors remain elusive. Few studies have had a sufficiently large number of patients, long follow-up time, and high follow-up rate for investigation. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Spinal Fusion
- What is being tested?
- observational study
- How many people
- 5,565 participants
- Where
- 1 siteTaiwan
- Study dates
- 11 Sep 2018to 30 Nov 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study included all patients who had been admitted for their first ACDF surgery during the 16-year span, began on January 1st, 1998 till the end of 2013, recorded in the NHIRD. The admission for cervical disc herniation and spondylosis were identified using the ICD9-CM diagnostic codes of 722.0, 722.4 and 722.71, while the surgery of ACDF was confirmed with the procedure codes of 80.51, 81.00 and 81.02 during the same hospitalization.
Who may be able to join
- patients who had been admitted for their first ACDF surgery during the 16-year span, began on January 1st, 1998 till the end of 2013, recorded in the NHIRD
Who cannot join
- any re-operation (i.e. ACDF) within 365 days from the indexed date of the first ACDF were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors of Second Surgery for Adjacent Segment Disease Following Anterior Cervical Discectomy and Fusion: a 16-year Cohort Study
Although the incidence of second surgery for adjacent segment disease (ASD) after anterior cervical discectomy and fusion (ACDF) has been reported, its risk factors remain elusive. Few studies have had a sufficiently large number of patients, long follow-up time, and high follow-up rate for investigation. To identify non-surgical risk factors of second surgery for ASD following ACDF, the study used a national cohort with comprehensive follow-up.
Read the detailed description
All second ACDF surgery after one year from the first ACDF were identified as a consequence of ASD that required another surgery. A multivariate competing risk survival model, Kaplan-Meier survivorship, and average time to events were calculated.
2.1. Data source and ethical concerns The study used the National Health Insurance Research Database (NHIRD), a national database containing 26 million administered insurants accumulated from January 1997 to December 2013, provided by the National Health Research Institutes of Taiwan. Due to the unique social-welfare health insurance system operated by the government, it is mandatory for every resident in Taiwan to be enrolled. Thus, the NHIRD has covered 99% of the population since its launch in 1996. The monopolistic national health insurance also offers unrestricted access to any healthcare provider of the patients' choices. The statistics, therefore, gathered by the NHIRD represent a sound cohort for investigation of the natural course and subsequent management of diseases. It is particularly good for studies that need longitudinal observation for repeat treatment (i.e. surgery for ASD) because it allows for the capture of events, even though they may occur in multiple or different institutes and hospitals. The universal coverage and comprehensive follow-up provided a valuable chance to study ASD.
All the personal information had already undergone a de-identification and encryption process. Individual and hospital identifiers are unique to the research database and researchers therefore cannot trace individual patients or health service providers.
- Conditions
- Spinal Fusion
- Being tested
- observational study
- Keywords
- Adjacent segment disease (ASD), Second surgery, Anterior cervical discectomy and fusion (ACDF), Risk factors, Cohort study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
this is an observational study, there is no intervention in this study
| Study group | Role | What they receive |
|---|---|---|
| Study Cohort | The observational study included all patients who had been admitted for their first ACDF surgery during the 16-year span, began on January 1st, 1998 till the end of 2013, recorded in the NHIRD. The admission for cervical disc herniation and spondylosis were identified using the ICD9-CM diagnostic codes of 722.0, 722.4 and 722.71, while the surgery of ACDF was confirmed with the procedure codes of 80.51, 81.00 and 81.02 during the same hospitalization. Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
The date of re-operation (Second ACDF)
Patients were followed-up for the subsequent surgery (second ACDF) after their index operation (first ACDF). We used the hospitalization date of each admission record as the date of outcome (second ACDF). Each patient was followed-up from his index surgery (first ACDF) to re-operation (second ACDF), death, or end of follow-up (2013/12/31) which comes first.
Measured: from patient's index surgery to the end of follow-up (2013/12/31), 4.66 years in average
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start11 Sep 2018
- Primary completion30 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal FusionStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe 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
- Retrospective
- Enrolment
- 5,565 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
- Investigators
- Yu-Chun Chen, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03826329
- Sponsor's protocol ID
- 2018-09-006CC
- Acronym
- 2nd ACDF
- Status last verified
- Jan 2019
- First submitted
- 27 Jan 2019
- Last updated
- 1 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The PI have no right to share the data
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors of Second Surgery for Adjacent Segment Disease Following Anterior Cervical Discectomy and Fusion: a 16-year Cohort Study
- ClinicalTrials.gov ID
- NCT03826329
- Acronym / sponsor ID
- 2nd ACDF / 2018-09-006CC
- Conditions
- Spinal Fusion
- Keywords
- Adjacent segment disease (ASD), Second surgery, Anterior cervical discectomy and fusion (ACDF), Risk factors, Cohort study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,565 participants (actual)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 11 Sep 2018 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 1 Feb 2019 (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.
Although the incidence of second surgery for adjacent segment disease (ASD) after anterior cervical discectomy and fusion (ACDF) has been reported, its risk factors remain elusive. Few studies have had a sufficiently large number of patients, long follow-up time, and high follow-up rate for investigation. To identify non-surgical risk factors of second surgery for ASD following ACDF, the study used a national cohort with comprehensive follow-up.
Detailed description
All second ACDF surgery after one year from the first ACDF were identified as a consequence of ASD that required another surgery. A multivariate competing risk survival model, Kaplan-Meier survivorship, and average time to events were calculated.
2.1. Data source and ethical concerns The study used the National Health Insurance Research Database (NHIRD), a national database containing 26 million administered insurants accumulated from January 1997 to December 2013, provided by the National Health Research Institutes of Taiwan. Due to the unique social-welfare health insurance system operated by the government, it is mandatory for every resident in Taiwan to be enrolled. Thus, the NHIRD has covered 99% of the population since its launch in 1996. The monopolistic national health insurance also offers unrestricted access to any healthcare provider of the patients' choices. The statistics, therefore, gathered by the NHIRD represent a sound cohort for investigation of the natural course and subsequent management of diseases. It is particularly good for studies that need longitudinal observation for repeat treatment (i.e. surgery for ASD) because it allows for the capture of events, even though they may occur in multiple or different institutes and hospitals. The universal coverage and comprehensive follow-up provided a valuable chance to study ASD.
All the personal information had already undergone a de-identification and encryption process. Individual and hospital identifiers are unique to the research database and researchers therefore cannot trace individual patients or health service providers.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | Other: observational studyThe observational study included all patients who had been admitted for their first ACDF surgery during the 16-year span, began on January 1st, 1998 till the end of 2013, recorded in the NHIRD. The admission for cervical disc herniation and spondylosis were identified using the ICD9-CM diagnostic codes of 722.0, 722.4 and 722.71, while the surgery of ACDF was confirmed with the procedure codes of 80.51, 81.00 and 81.02 during the same hospitalization. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study included all patients who had been admitted for their first ACDF surgery during the 16-year span, began on January 1st, 1998 till the end of 2013, recorded in the NHIRD. The admission for cervical disc herniation and spondylosis were identified using the ICD9-CM diagnostic codes of 722.0, 722.4 and 722.71, while the surgery of ACDF was confirmed with the procedure codes of 80.51, 81.00 and 81.02 during the same hospitalization.
Key inclusion criteria (1 listed)
- patients who had been admitted for their first ACDF surgery during the 16-year span, began on January 1st, 1998 till the end of 2013, recorded in the NHIRD
Key exclusion criteria (1 listed)
- any re-operation (i.e. ACDF) within 365 days from the indexed date of the first ACDF were excluded.
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 |
|---|---|---|
| observational studythis is an observational study, there is no intervention in this study | Other | Study Cohort |
Primary outcome
The date of re-operation (Second ACDF)
Time frame: from patient's index surgery to the end of follow-up (2013/12/31), 4.66 years in average
Patients were followed-up for the subsequent surgery (second ACDF) after their index operation (first ACDF). We used the hospitalization date of each admission record as the date of outcome (second ACDF). Each patient was followed-up from his index surgery (first ACDF) to re-operation (second ACDF), death, or end of follow-up (2013/12/31) which comes first.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2019.
- Individual participant dataSharing planned: No. The PI have no right to share the data
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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. This study is not recruiting at the moment.
Yu-Chun Chen principal investigator
Taipei Veterans General Hospital, Taiwan
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 Spinal Fusion, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 1 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: finished, as of the sponsor's last update on 1 Feb 2019. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The date of re-operation (Second ACDF) (time frame: from patient's index surgery to the end of follow-up (2013/12/31), 4.66 years in average). 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 1 Feb 2019.