Real World Adverse Events of Interspinous Spacers Using Manufacturer and User Facility Device Experience Data

Overview

Journal Anesth Pain Med (Seoul)

Specialty Anesthesiology

Date 2021 Apr 19

PMID 33866770

Citations 2

Authors

Nitish Aggarwal

Robert Chow

Affiliations

Soon will be listed here.

Abstract

Background: Lumbar spinal stenosis is a condition of progressive neurogenic claudication that can be managed with lumbar decompression surgery or less invasive interspinous process devices after failed conservative therapy. Popular interspinous process spacers include X-Stop, Vertiflex and Coflex, with X-Stop being taken off market due to its adverse events profile.

Methods: A disproportionality analysis was conducted to determine whether a statistically significant signal exists in the three interspinous spacers and the reported adverse events using the Manufacturer and User Facility Device Experience (MAUDE) database maintained by the US Food and Drug Administration.

Results: Statistically significant signals were found with each of the three interspinous spacer devices (Coflex, Vertiflex, and X-Stop) and each of the following adverse events: fracture, migration, and pain/worsening symptoms.

Conclusions: Further studies such as randomized controlled trials are needed to validate the findings.

Citing Articles

Complications and radiographic changes after implantation of interspinous process devices: average eight-year follow-up.

Li K, Li H, Chen L, Xiang J, Li C, Weng J BMC Musculoskelet Disord. 2023; 24(1):667.

PMID: 37612739 PMC: 10463994. DOI: 10.1186/s12891-023-06798-9.

Biomechanical comparison of different interspinous process devices in the treatment of lumbar spinal stenosis: a finite element analysis.

Liu Z, Zhang S, Li J, Tang H BMC Musculoskelet Disord. 2022; 23(1):585.

PMID: 35715775 PMC: 9204899. DOI: 10.1186/s12891-022-05543-y.

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