TY - JOUR
T1 - The SNAP Trial
T2 - 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
AU - Kersten, R F M R
AU - Öner, F C
AU - Arts, M P
AU - Mitroiu, M
AU - Roes, K C B
AU - de Gast, A
AU - van Gaalen, S M
N1 - Funding Information:
The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was funded by Amedica Corporation, Salt Lake City, UT, USA.
Publisher Copyright:
© The Author(s) 2021.
PY - 2022/10
Y1 - 2022/10
N2 - 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 (Si3N4) is an alternative material with good osteointegrative properties. This study was designed to assess if Si3N4 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 Si3N4 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 (i.e. 48 to PEEK and 44 to Si3N4). 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 Si3N4 cohort. Although not statistically significant, there was a higher incidence of complications and revisions associated with the Si3N4 cage.CONCLUSIONS: There was insufficient evidence to conclude that Si3N4 was non-inferior to PEEK.
AB - 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 (Si3N4) is an alternative material with good osteointegrative properties. This study was designed to assess if Si3N4 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 Si3N4 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 (i.e. 48 to PEEK and 44 to Si3N4). 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 Si3N4 cohort. Although not statistically significant, there was a higher incidence of complications and revisions associated with the Si3N4 cage.CONCLUSIONS: There was insufficient evidence to conclude that Si3N4 was non-inferior to PEEK.
KW - degenerative disc disease
KW - lumbar spinal fusion
KW - polyetheretherketone (PEEK)
KW - randomized controlled trial
KW - silicon nitride (Si N )
UR - http://www.scopus.com/inward/record.url?scp=85099002631&partnerID=8YFLogxK
U2 - 10.1177/2192568220985472
DO - 10.1177/2192568220985472
M3 - Article
C2 - 33406905
SN - 2192-5682
VL - 12
SP - 1687
EP - 1695
JO - Global Spine Journal
JF - Global Spine Journal
IS - 8
ER -