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Thermal Localization Improves the Interlayer Adhesion and Structural Integrity of 3D printed PEEK Lumbar Spinal Cages.

ABSTRACT: Additive manufacturing (AM) is a potential application for polyetheretherketone (PEEK) spinal interbody fusion cages, which were introduced as an alternative to titanium cages because of their biocompatibility, radiolucency and strength. However, AM of PEEK is challenging due to high melting temperature and thermal gradient. Although fused filament fabrication (FFF) techniques have been shown to 3D print PEEK, layer delamination was identified in PEEK cages printed with a first generation FFF PEEK printer [1]. A standard cage design [2] was 3D printed with a second generation FFF PEEK printer. The effect of changing layer cooling time on FFF cages' mechanical strength was investigated by varying nozzle sizes (0.2 mm and 0.4 mm), print speeds (1500 and 2500 mm/min), and the number of cages printed in a single build (1, 4 and 8). To calculate the porosity percentage, FFF cages were micro-CT scanned prior to destructive testing. Mechanical tests were then conducted on FFF cages according to ASTM F2077 [2]. Although altering the cooling time of a layer was not able to change the failure mechanism of FFF cages, it was able to improve cages' mechanical strength. Printing a single cage per build caused a higher ultimate load than printing multiple cages per build. Regardless of the cage number printed per build, cages printed with bigger nozzle diameter achieved higher ultimate load compared to cages printed with smaller nozzle diameter. Printing with a bigger nozzle diameter resulted in less porosity, which might have an additional affect on the interlayer delamination failure mechanism.

SUBMITTER: Basgul C

PROVIDER: S-EPMC7172383 | biostudies-literature |

REPOSITORIES: biostudies-literature

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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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Thermal Localization Improves the Interlayer Adhesion and Structural Integrity of 3D printed PEEK Lumbar Spinal Cages.

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