The SNAP Trial: 2-Year Results of a Double-Blind Multicenter Randomized Controlled Trial of a Silicon Nitride Versus a PEEK Cage in Patients After Lumbar Fusion Surgery

Overview

Journal Global Spine J

Publisher Sage Publications

Date 2021 Jan 7

PMID 33406905

Citations 7

Authors

R F M R Kersten

F C Oner

M P Arts

M Mitroiu

K C B Roes

A De Gast

S M van Gaalen

Affiliations

Soon will be listed here.

Abstract

Study Design: Randomized controlled trial.

Objectives: Lumbar interbody fusion with cages is performed to provide vertebral stability, restore alignment, and maintain disc and foraminal height. Polyetheretherketone (PEEK) is commonly used. Silicon nitride (SiN) is an alternative material with good osteointegrative properties. This study was designed to assess if SiN cages perform similar to PEEK.

Methods: A non-inferiority double-blind multicenter RCT was designed. Patients presenting with chronic low-back pain with or without leg pain were included. Single- or double-level instrumented transforaminal lumbar interbody fusion (TLIF) using an oblique PEEK or SiN cage was performed. The primary outcome was the Roland-Morris Disability Questionnaire (RMDQ). The non-inferiority margin for the RMDQ was 2.6 points on a scale of 24. Secondary outcomes included the Oswestry Disability Questionnaire (ODI), Visual Analogue Scales (VAS), SF-36 Physical Function, patient and surgeon Likert scores, radiographic evaluations for subsidence, segmental motion, and fusion. Follow-up was planned at 3, 6, 12, and 24-months.

Results: Ninety-two patients were randomized ( 48 to PEEK and 44 to SiN). Both groups showed good clinical improvements on the RMDQ scores of up to 5-8 points during follow-up. No statistically significant differences were observed in clinical and radiographic outcomes. Mean operative time and blood loss were statistically significantly higher for the SiN cohort. Although not statistically significant, there was a higher incidence of complications and revisions associated with the SiN cage.

Conclusions: There was insufficient evidence to conclude that SiN was non-inferior to PEEK.

Citing Articles

Bone Grafting Options for Single-Level TLIF: So Many Options, What Is the Evidence?.

Kim E, Brennan M, Margabandu P, Oska N, Robles M, Rademacher A Int J Spine Surg. 2023; 17(S3):S53-S60.

PMID: 38124018 PMC: 10753332. DOI: 10.14444/8561.

Three-Dimensional-Printed Titanium Versus Polyetheretherketone Cages for Lumbar Interbody Fusion: A Systematic Review of Comparative In Vitro, Animal, and Human Studies.

Patel N, OBryant S, Rogers C, Boyett C, Chakravarti S, Gendreau J Neurospine. 2023; 20(2):451-463.

PMID: 37401063 PMC: 10323354. DOI: 10.14245/ns.2346244.122.

A Systematic Review and Meta-Analysis of Silicon Nitride and Biomaterial Modulus as it Relates to Subsidence Risk in Spinal Fusion Surgery.

Ament J, Vokshoor A, Yee R, Johnson J N Am Spine Soc J. 2022; 12:100168.

PMID: 36147584 PMC: 9486012. DOI: 10.1016/j.xnsj.2022.100168.

Bioactive Silicon Nitride Implant Surfaces with Maintained Antibacterial Properties.

Katsaros I, Zhou Y, Welch K, Xia W, Persson C, Engqvist H J Funct Biomater. 2022; 13(3).

PMID: 36135564 PMC: 9500919. DOI: 10.3390/jfb13030129.

Transforaminal lumbar interbody fusion with a silicon nitride cage demonstrates early radiographic fusion.

Gray M, Davis K, McEntire B, Bal B, Smith M J Spine Surg. 2022; 8(1):29-43.

PMID: 35441113 PMC: 8990392. DOI: 10.21037/jss-21-115.

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