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Risk Factors of Second Surgery for Adjacent Segment Disease Following Anterior Cervical Discectomy and Fusion (2nd ACDF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03826329
Recruitment Status : Completed
First Posted : February 1, 2019
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
vghtpe user, Taipei Veterans General Hospital, Taiwan

Tracking Information
First Submitted Date January 27, 2019
First Posted Date February 1, 2019
Last Update Posted Date February 1, 2019
Actual Study Start Date September 11, 2018
Actual Primary Completion Date November 30, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 30, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Risk Factors of Second Surgery for Adjacent Segment Disease Following Anterior Cervical Discectomy and Fusion
Official Title Risk Factors of Second Surgery for Adjacent Segment Disease Following Anterior Cervical Discectomy and Fusion: a 16-year 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
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.
Condition Spinal Fusion
Intervention Other: observational study
this is an observational study, there is no intervention in this study
Study Groups/Cohorts 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.
Intervention: Other: observational study
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 30, 2019)
5565
Original Actual Enrollment Same as current
Actual Study Completion Date November 30, 2018
Actual Primary Completion Date November 30, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03826329
Other Study ID Numbers 2018-09-006CC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: The PI have no right to share the data
Responsible Party vghtpe user, Taipei Veterans General Hospital, Taiwan
Study Sponsor Taipei Veterans General Hospital, Taiwan
Collaborators Not Provided
Investigators
Principal Investigator: Yu-Chun Chen Taipei Veterans General Hospital, Taiwan
PRS Account Taipei Veterans General Hospital, Taiwan
Verification Date January 2019