scholarly journals Randomized Controlled Trial of Posterior Lumbar Interbody Fusion With Ti- and CaP-Nanocoated Polyetheretherketone Cages: Comparative Study of the 1-Year Radiological and Clinical Outcome

10.14444/6080 ◽  
2020 ◽  
Vol 13 (6) ◽  
pp. 575-587
Author(s):  
KAREL WILLEMS ◽  
PHILIPPE LAUWERYNS ◽  
GINO VERLEYE ◽  
JOHAN VAN GOETHEM
Keyword(s):  
Randomized Controlled Trial ◽  
Clinical Outcome ◽  
Comparative Study ◽  
Interbody Fusion ◽  
Controlled Trial ◽  
Posterior Lumbar Interbody Fusion ◽  
Lumbar Interbody Fusion ◽  
Randomized Controlled

scholarly journals Feasibility And Safety of A CaO-SiO2-P2O5-B2O3 Bioactive Glass Ceramic Spacer In Posterior Lumbar Interbody Fusion: A Prospective Randomized Controlled Trial

2021 ◽  
Author(s):  
Byung-Taek Kwon ◽  
Ho-Joong Kim ◽  
Sang-Min Park ◽  
Dae-Woong Ham ◽  
Ohsang Kwon ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Glass Ceramic ◽  
Interbody Fusion ◽  
Controlled Trial ◽  
Posterior Lumbar Interbody Fusion ◽  
Lumbar Interbody Fusion ◽  
Peek Cage ◽  
Randomized Controlled ◽  
Spacer Group ◽  
Prospective Randomized Controlled Trial

Abstract Study design: Prospective randomized controlled trial.Background: The CaO-SiO2-P2O5-B2O3 glass-ceramic (BGS-7) spacer is a recently developed spacer that shows chemical bonding to bone with high mechanical stability. Further, this spacer achieves similar results to those of titanium cages. However, evidence regarding the advantages of the BGS-7 spacer is weak compared to polyetheretherketone (PEEK) cage. A randomized controlled trial is therefore warranted. The purpose of this study was to compare the radiographic and clinical efficacies and safety of the BGS-7 spacer compared to those of the PEEK cage in patients who underwent posterior lumbar interbody fusion (PLIF). Methods: The 54 participants who required one- or two-level PLIF due to lumbar degenerative disorders were randomly assigned to receive a BGS-7 spacer or PEEK cage. Visual analog scale (VAS), Oswestry Disability Index (ODI), European Quality of Life-5 Dimensions (EQ-5D), painDETECT score were evaluated before surgery and at 3, 6, and 12 months after surgery. The fusion rate, degree of osteolysis, cage migration and subsidence around the cage (spacer) were evaluated on computer tomography (CT) images at 12 months after surgery. Results: The 12-month fusion rates were 75% in the BGS-7 spacer group and 79.3% in the PEEK cage group, with no significant difference (p=0.676). The result regarding the non-inferiority of BGS-7 spacer was inconclusive. The linear mixed model showed no significant intervention effect in VAS, ODI, EQ-5D, and painDETECT score at the 3-, 6-, or 12-month follow-up. In addition, we found no significant between-group differences in the extent of osteolysis, spacer migration. However, the subsidence around the cage was significantly lower in the BGS-7 spacer group. Conclusions: This trial found similar fusion rates, clinicoradiographic outcomes, and adverse events between the BGS-7 spacer and PEEK cage for PLIF. However, the non-inferiority was inconclusive, and thus, the BGS-7 spacer can be a feasible and safe alternative to PEEK cage in PLIF surgery after further studies.

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

2021 ◽  
pp. 219256822098547
Author(s):  
R. F. M. R. Kersten ◽  
F. C. Öner ◽  
M. P. Arts ◽  
M. Mitroiu ◽  
K. C. B. Roes ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Silicon Nitride ◽  
Interbody Fusion ◽  
Controlled Trial ◽  
Segmental Motion ◽  
Lumbar Interbody Fusion ◽  
Double Blind ◽  
Randomized Controlled ◽  
Disability Questionnaire

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.

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