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Clinical outcomes for lumbar fusion using silicon nitride versus other biomaterials.

ABSTRACT: Background:In lumbar fusion surgery, intervertebral spacer cages made of silicon nitride (Si3N4) ceramic are an available option among other biomaterials. While the surface chemistry of Si3N4 is known to favor bone fusion, large-scale clinical studies attesting to its efficacy are lacking. This multicenter retrospective study compared lumbar fusion outcomes for Si3N4 cages to previously reported data for other cage materials. Methods:Pre-operative patient demographics, comorbidities, changes in visual analog scale (?VAS) pain scores, complications, adverse events, and secondary surgical interventions (SSI) were compiled from the records of 450 patients who underwent Si3N4 lumbar spinal fusion at four separate U.S. surgical centers. For comparison, MEDLINE/PubMed and Google Scholar searches identified studies reporting similar outcomes for other biomaterials. A total of 1,025 patients from 26 cohorts reported in 14 publications met inclusion criteria for this control group. Results:Overall, the mean last-follow-up for all patients was 341±293 days (11.4±9.8 months), with the longest follow-up being 6.4 years. Patients with Si3N4 implants were similar in gender and age distribution to the control group but had higher BMI values (30.9±6.1 vs. 25.8±4.1, P<0.01) and lower tobacco use (15.8% vs. 30.0%, P<0.01). Both the Si3N4 and control groups showed significant improvements in VAS pain scores from preoperative to last follow-up. For the Si3N4 group, ?VAS was 36.8±35.4 points compared to 37.6±22.5 points (P=0.63) for the metadata group. Complications and reoperations for the Si3N4 and the control groups were similar (i.e., 9.8% and 3.1% versus 12.4% and 2.9%, P=0.16 and P=0.84, respectively). Conclusions:Lumbar fusion with Si3N4 spacers compared favorably with the improvements reported with other commonly used biomaterial cages.

SUBMITTER: Calvert GC

PROVIDER: S-EPMC7154368 | biostudies-literature | 2020 Mar

REPOSITORIES: biostudies-literature

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Clinical outcomes for lumbar fusion using silicon nitride versus other biomaterials.

Calvert Graham C GC VanBuren Huffmon George G Rambo William M WM Smith Micah W MW McEntire Bryan J BJ Bal B Sonny BS

Journal of spine surgery (Hong Kong) 20200301 1

<h4>Background</h4>In lumbar fusion surgery, intervertebral spacer cages made of silicon nitride (Si3N4) ceramic are an available option among other biomaterials. While the surface chemistry of Si3N4 is known to favor bone fusion, large-scale clinical studies attesting to its efficacy are lacking. This multicenter retrospective study compared lumbar fusion outcomes for Si3N4 cages to previously reported data for other cage materia ...[more]

PMID: 32309644

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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.

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Clinical outcomes for lumbar fusion using silicon nitride versus other biomaterials.

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Clinical outcomes for lumbar fusion using silicon nitride versus other biomaterials.

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