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

NCT03826329 | Completed

• 1 other identifier: 2018-09-006CC
• Study Type: observational
• Target: 5,565
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Fusion

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  from patient's index surgery to the end of follow-up (2013/12/31), 4.66 years in average

Study Arms (1)

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.

Other: observational study

Interventions

observational study OTHER

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

Study Cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Yu-Chun Chen

Taipei, Taiwan

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Yu-Chun Chen

  Taipei Veterans General Hospital, Taiwan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 27, 2019
• First Posted: February 1, 2019
• Study Start: September 11, 2018
• Primary Completion: November 30, 2018
• Study Completion: November 30, 2018
• Last Updated: February 1, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)