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Risk Factors of Second Surgery for Adjacent Segment Disease Following Anterior Cervical Discectomy and Fusion

Risk Factors of Second Surgery for Adjacent Segment Disease Following Anterior Cervical Discectomy and Fusion: a 16-year Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03826329
Acronym
2nd ACDF
Enrollment
5565
Registered
2019-02-01
Start date
2018-09-11
Completion date
2018-11-30
Last updated
2019-02-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Fusion

Keywords

Adjacent segment disease (ASD), Second surgery, Anterior cervical discectomy and fusion (ACDF), Risk factors, Cohort study

Brief 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. 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.

Interventions

OTHERobservational study

this is an observational study, there is no intervention in this study

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* any re-operation (i.e. ACDF) within 365 days from the indexed date of the first ACDF were excluded.

Design outcomes

Primary

MeasureTime frameDescription
The date of re-operation (Second ACDF)from patient's index surgery to the end of follow-up (2013/12/31), 4.66 years in averagePatients 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.

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026