Dataset Information

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.

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 (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.

SUBMITTER: Kersten RFMR

PROVIDER: S-EPMC9609539 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

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Publications

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.

Kersten R F M R RFMR Öner F C FC Arts M P MP Mitroiu M M Roes K C B KCB de Gast A A van Gaalen S M SM

Global spine journal 20210107 8

<h4>Study design</h4>Randomized controlled trial.<h4>Objectives</h4>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 (Si<sub>3</sub>N<sub>4</sub>) is an alternative material with good osteointegrative properties. This study was designed to assess if Si<sub>3</sub>N<sub>4</sub> cages perform similar to PEEK.<h4>Methods</h4>A non-inferiority double ...[more]

PMID: 33406905

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Project description:BackgroundPolyetheretherketone (PEEK) cages have been widely used in the treatment of lumbar degenerative disc disorders, and show good clinical results. Still, complications such as subsidence and migration of the cage are frequently seen. A lack of osteointegration and fibrous tissues surrounding PEEK cages are held responsible. Ceramic implants made of silicon nitride show better biocompatible and osteoconductive qualities, and therefore are expected to lower complication rates and allow for better fusion.Purpose of this study is to show that fusion with the silicon nitride cage produces non-inferior results in outcome of the Roland Morris Disability Questionnaire at all follow-up time points as compared to the same procedure with PEEK cages.Methods/designThis study is designed as a double blind multi-center randomized controlled trial with repeated measures analysis. 100 patients (18-75 years) presenting with symptomatic lumbar degenerative disorders unresponsive to at least 6 months of conservative treatment are included. Patients will be randomly assigned to a PEEK cage or a silicon nitride cage, and will undergo a transforaminal lumbar interbody fusion with pedicle screw fixation. Primary outcome measure is the functional improvement measured by the Roland Morris Disability Questionnaire. Secondary outcome parameters are the VAS leg, VAS back, SF-36, Likert scale, neurological outcome and radiographic assessment of fusion. After 1 year the fusion rate will be measured by radiograms and CT. Follow-up will be continued for 2 years. Patients and clinical observers who will perform the follow-up visits will be blinded for type of cage used during follow-up. Analyses of radiograms and CT will be performed independently by two experienced radiologists.DiscussionIn this study a PEEK cage will be compared with a silicon nitride cage in the treatment of symptomatic degenerative lumbar disc disorders. To our knowledge, this is the first randomized controlled trial in which the silicon nitride cage is compared with the PEEK cage in patients with symptomatic degenerative lumbar disc disorders.Trial registrationNCT01557829.

Project description:BackgroundDuring lumbar spinal fusion, spacer cages are implanted to provide vertebral stability, restore sagittal alignment, and maintain disc and foraminal height. Polyetheretherketone (PEEK) is commonly used by most spine surgeons. Silicon nitride (Si3N4) is a less well-known alternative although it was first used as a spacer in lumbar fusion over 30 years ago. The present study was designed to see if Si3N4 cages would perform similarly to PEEK in a randomized controlled trial.MethodsA non-inferiority multicenter 100-patient study was designed where both the observer and patient were blinded. Single- or double-level transforaminal lumbar interbody fusion with pedicle screw fixation using an oblique PEEK or Si3N4 cage was performed. The primary non-inferiority outcome was the Roland-Morris Disability Questionnaire (RMDQ). Secondary measures included the Oswestry Disability Questionnaire, Visual Analogue Scales (VAS) for back and leg pain, SF-36 Physical and Mental Function indices, patient and surgeon Likert scores on perceived recovery, and X-ray and CT radiological evaluations for subsidence, segmental motion, and fusion. Follow-up evaluations occurred at 3, 6, 12, and 24 months.ResultsAfter exclusions for protocol violations and canceled surgeries, 92 patients were randomized (i.e., 48 for PEEK and 44 for Si3N4). There were no differences in baseline demographics, pre-operative disabilities, or pain scores between the groups. Both treatment arms showed significant improvements in disability, pain, and recovery scores. No significant differences were observed for subsidence, segmental motion, or fusion. For the primary outcome (i.e., RMDQ scores), the non-inferiority of Si3N4 compared to PEEK could not be established using the original protocol criteria. However, the comparison was undermined by larger than anticipated patient fallout coupled with higher than expected RMDQ score standard deviations. A post hoc analysis coupled with a more extensive review of the literature was conducted which resulted in the selection of a revised clinically justified non-inferiority margin; and using this method, the non-inferiority of Si3N4 was affirmed.ConclusionsThis study demonstrated that the use of either PEEK or Si3N4 cages is safe and effective for patients undergoing lumbar spine fusion for chronic degenerative disc disease.

Project description:ObjectivePrevious studies have confirmed that the nanohydroxyapatite/polyamide-66 (n-HA/PA66) cage is an ideal alternative material for degenerative lumbar disease (DLD) comparable to the polyether ether ketone (PEEK) cage due to its similar radiographic fusion, subsidence rate, and clinical results. However, these studies were restricted to one-level surgery. The aim of this study was to analyze the long-term clinical and radiologic outcomes between n-HA PA66 cage and PEEK cage for patients with multi-level degenerative lumbar diseases (DLDs).MethodsWe retrospectively reviewed all patients who underwent multi-level transforaminal lumbar interbody fusion (TLIF) from June 2010 to December 2016 with a minimum 6-year follow-up. Matched-pair analysis was performed using a 1-to-1 closest neighbor approach to match patients who received an n-HA PA66 cage with those who received a PEEK cage. Clinical outcomes and radiographic evaluations were compared between the two groups. The independent student's t-test and χ2 -test were applied to compare the differences between groups.ResultsAt the end of the propensity score matching (PSM) analysis, 48 patients from n-HA/PA66 group were matched to 48 patients in the PEEK group. No significant difference was observed in cage subsidence and bony fusion except for adjacent segment degeneration (ASD). The occurrence of ASD was 14.58% (7/48) in the n-HA/PA 66 group, which was significantly less than that in the PEEK group (33.33% [16/48]) (p = 0.031). Although the intervertebral space height (IH), segmental angle (SA) and lumbar lordosis (LL) significantly increased after surgery in both groups, there was no significant difference at any time point after surgery (p > 0.05). The visual analogue scale (VAS) and Oswestry disability index (ODI) scores significantly improved in both groups at 3m postoperative, 1y postoperative and at final follow-up. However, there were no significant differences in the VAS and ODI score at any time point (p > 0.05). The total complications and re-admission rate were not different between the two groups.ConclusionOverall, our data suggest that the outcomes of n-HA/PA66 cage group are comparable to those of the PEEK cage group, with a similar high fusion rate and low cage subsidence rate as PEEK cages, except its lower rate of ASD occurrence.

Project description:ObjectivesThe three-dimensional printing titanium (3DPT) cage with excellent biomechanical properties and osseointegration capabilities has been initially used in spinal fusion, while the polyetheretherketone (PEEK) cage, a bioinert material device, has been a widely used for decades with relatively excellent clinical outcomes. This study was performed to investigate the early radiographic and clinical outcomes of 3DPT cage versus PEEK cage in patients undergoing anterior cervical discectomy and fusion (ACDF) and transforaminal lumbar interbody fusion (TLIF).MethodsThis prospective controlled trial, from December 2019 to June 2022, included patients undergoing ACDF and TLIF with 3DPT cages and compared them to patients using PEEK cages for treating spinal degenerative disorders. The outcome measures included radiographic parameters (intervertebral height [IH], subsidence, fusion status, and bone-cage interface contact) and clinical outcomes (Japanese Orthopaedic Association [JOA], Neck Disability Index [NDI], Oswestry Disability Index [ODI], Short Form 12-Item Survey [SF-12], Visual Analog Scale [VAS], and Odom's criteria). Student's independent samples t test and Pearson's chi-square test were used to compare the outcome measures between the two groups before surgery and at 1 week, 3 and 6 months after surgery.ResultsFor the patients undergoing ACDF, the 3DPT (18 patients/[26 segments]) and PEEK groups (18 patients/[26 segments]) had similar fusion rates at 3 months and 6 months follow-up (3 months: 96.2% vs. 83.3%, p = 0.182; 6 months: 100% vs. 91.7%, p = 0.225). The subsidence in the 3DPT group was significantly lower than that in the PEEK group (3 months: 0.4 ± 0.2 mm vs. 0.9 ± 0.7 mm p = 0.004; 6 months: 0.7 ± 0.3 mm vs. 1.5 ± 0.8 mm, p < 0.001). 3DPT and PEEK cage all achieved sufficient contact with the cervical endplates. For the patients undergoing TLIF, the 3DPT (20 patients/[26 segments]) and PEEK groups (20 patients/[24 segments]) had no statistical difference in fusion rate (3 months: 84.6% vs. 58.3%, p = 0.059; 6 months: 92.3% vs. 75%, p = 0.132). The subsidence was lower than that in the PEEK group without significantly difference (3 months: 0.9 ± 0.7 mm vs.1.2 ± 0.9 mm p = 0.136; 6 months: 1.6 ± 1.0 mm vs. 2.0 ± 1.0 mm, p = 0.200). At the 3-month follow-up, the bone-cage interface contact of the 3DPT cage was significantly better than that of the PEEK cage (poor contact: 15.4% vs. 75%, p < 0.001). The values of UAR were higher in the 3DPT group than in the PEEK group during the follow-up in cervical and lumbar fusion, there were more statistical differences in lumbar fusion. There were no significant differences in the clinical assessment between 3DPT or PEEK cage in spinal fusion.ConclusionThe 3DPT cage and PEEK cage can achieve excellent clinical outcomes in cervical and lumbar fusion. The 3DPT cage has advantage in fusion quality, subsidence severity, and bone-cage interface contact than PEEK cage.

Dataset Information

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.

Study design

Objectives

Methods

Results

Conclusions

Publications

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.

Similar Datasets

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