RT Journal Article
SR Electronic
T1 Evaluation of intervertebral body implant performance using active surveillance of electronic health records
JF BMJ Surgery, Interventions, & Health Technologies
FD BMJ Publishing Group Ltd
SP e000125
DO 10.1136/bmjsit-2021-000125
VO 4
IS 1
A1 Edward A Frankenberger
A1 Frederic S Resnic
A1 Henry Ssemaganda
A1 Susan Robbins
A1 Melissa R Dunbar
A1 Paul Coplan
A1 Shumin Zhang
A1 Cortney Bruno
A1 Mitchell Maltenfort
A1 Jillian B Benedetti
A1 Michael E Matheny
A1 Zoher Ghogawala
YR 2022
UL http://sit.bmj.com/content/4/1/e000125.abstract
AB Objectives To assess the feasibility of using electronic health record (EHR) derived clinical data within an active surveillance setting to evaluate the safety of a novel intervertebral body implant (IVBI) stabilization device.Design Retrospective, longitudinal observational cohort study comparing clinical outcomes for patients seen through 1 year following spinal fusion surgery.Setting Lahey Health network, which includes academic tertiary hospitals, outpatient clinics, and independent provider offices in the New England region of the USA.Participants All spine surgery patients aged 18 or older who underwent thoracic or lumbar spinal arthrodesis surgeries were included.Main outcome measures The clinical outcomes of patients treated with the CONCORDE Bullet (CB) interbody spine system (DePuy) between April 2015 and December 2018 were compared with those patients receiving alternative spine stabilization interbody device implants. The primary endpoint was reoperation rate at 1 year, with secondary endpoints including the requirement for blood transfusion during index hospitalization, 1 year rate of any cause hospitalization, 1 year rate of surgical site infection, and mortality at 1 year.Results Among the 606 patients undergoing thoracic or lumbar spinal fusion surgery during the study period, 136 received only the CB. In comparison with patients who did not receive the CB, no significant differences were found in the rate of reoperation at 1 year or the rates of secondary safety outcomes.Conclusions Data derived from the EHR can be successfully leveraged to assess the safety of IVBI devices, in this case demonstrating no significant differences in the rates of risk-adjusted safety endpoints between patients undergoing spinal surgery with the CB as compared with alternative spinal implants.Data are available upon reasonable request. De-identified data supporting the findings of this study may be available from the corresponding author (EAF) upon reasonable request.