title: Adverse Event Recording and Reporting in Clinical Trials Comparing Lumbar Disk Replacement with Lumbar Fusion: A Systematic Review.
abstract: Study Design Systematic review. Objectives (1) To compare the quality of adverse event (AE) methodology and reporting among randomized trials comparing lumbar fusion with lumbar total disk replacement (TDR) using established AE reporting systems; (2) to compare the AEs and reoperations of lumbar spinal fusion with those from lumbar TDR; (3) to make recommendations on how to report AEs in randomized controlled trials (RCTs) so that surgeons and patients have more-detailed and comprehensive information when making treatment decisions. Methods A systematic search of PubMed, the Cochrane collaboration database, and the National Guideline Clearinghouse through May 2015 was conducted. Randomized controlled trials with at least 2 years of follow-up comparing lumbar artificial disk replacement with lumbar fusion were included. Patients were required to have axial or mechanical low back pain of ≥3 months' duration due to degenerative joint disease defined as degenerative disk disease, facet joint disease, or spondylosis. Outcomes included the quality of AE acquisition methodology and results reporting, and AEs were defined as those secondary to the procedure and reoperations. Individual and pooled relative risks and their 95% confidence intervals comparing lumbar TDR with fusion were calculated. Results RCTs demonstrated a generally poor description of methods for assessing AEs. There was a consistent lack of clear definition or grading for these events. Furthermore, there was a high degree of variation in reporting of surgery-related AEs. Most studies lacked adequate reporting of the timing of AEs, and there were no clear distinctions between acute or chronic AEs. Meta-analysis of the pooled data demonstrated a twofold increased risk of AEs in patients having lumbar fusion compared with patients having lumbar TDR at 2-year follow-up, and this relative risk was maintained at 5 years. Furthermore, the pooled data demonstrated a 1.7 times greater relative risk of reoperation in the fusion group compared with lumbar TDR, although this risk decreased to 1.1 at 5-year follow-up. However, given the lack of quality and consistency in the methods of recording and reporting of AEs, we are unable to make a clear recommendation of one treatment over the other. Conclusions Based on the currently available literature, lumbar TDR appears to be comparable in safety to lumbar fusion. However, due to lack of consistency in reporting of AEs, it is difficult to make conclusions regarding the true safety profile of lumbar TDR. Standardization in AE reporting will significantly improve the reliability of the current literature.
authors.affiliation: Department of Orthopaedics and Rehabilitation, Oregon Health and Science University, Portland, Oregon, United States.
authors.forename: Jayme
authors.initials: J
authors.lastname: Hiratzka
authors.affiliation: Department of Orthopaedics and Rehabilitation, Oregon Health and Science University, Portland, Oregon, United States.
authors.forename: Farbod
authors.initials: F
authors.lastname: Rastegar
authors.affiliation: Department of Orthopaedics and Rehabilitation, Oregon Health and Science University, Portland, Oregon, United States.
authors.forename: Alec G
authors.initials: AG
authors.lastname: Contag
authors.affiliation: Spectrum Research, Inc., Tacoma, Washington, United States.
authors.forename: Daniel C
authors.initials: DC
authors.lastname: Norvell
authors.affiliation: Department of Orthopedics and Rehabilitation, University of Wisconsin, Madison, Wisconsin, United States.
authors.forename: Paul A
authors.initials: PA
authors.lastname: Anderson
authors.affiliation: Department of Orthopaedics and Rehabilitation, Oregon Health and Science University, Portland, Oregon, United States.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Hart
keywords: adverse events; disk replacement; lumbar fusions; spine surgery; structured review