Eric H Ledet1, Glenn P Sanders2, Darryl J DiRisio3, Joseph C Glennon4. 1. ReVivo Medical, 33 Old Niskayuna Rd, Loudonville, NY 12211, USA; Department of Biomedical Engineering, Rensselaer Polytechnic Institute, 110 8th St, Troy, NY 12180, USA; R&D Service, Stratton VA Medical Center, 113 Holland Ave, Albany, NY, 12208, USA. Electronic address: eledet@revivomedical.com. 2. ReVivo Medical, 33 Old Niskayuna Rd, Loudonville, NY 12211, USA. 3. ReVivo Medical, 33 Old Niskayuna Rd, Loudonville, NY 12211, USA; Department of Neurosurgery, Albany Medical College, 47 New Scotland Ave, Albany, NY 12208, USA. 4. Veterinary Specialties Referral Center, 1641 Main St, Pattersonville, NY 12137, USA.
Abstract
BACKGROUND CONTEXT: Achieving a successful spinal fusion requires the proper biological and biomechanical environment. Optimizing load-sharing in the interbody space can enhance bone formation. For anterior cervical discectomy and fusion (ACDF), loading and motion are largely dictated by the stiffness of the plate, which can facilitate a balance between stability and load-sharing. The advantages of load-sharing may be substantial for patients with comorbidities and in multilevel procedures where pseudarthrosis rates are significant. PURPOSE: We aimed to evaluate the efficacy of a novel elastically deformable, continuously load-sharing anterior cervical spinal plate for promotion of bone formation and interbody fusion relative to a translationally dynamic plate. STUDY DESIGN/ SETTING: An in vivo animal model was used to evaluate the effects of an elastically deformable spinal plate on bone formation and spine fusion. METHODS: Fourteen goats underwent an ACDF and received either a translationally dynamic or elastically deformable plate. Animals were followed up until 18 weeks and were evaluated by plain x-ray, computed tomography scan, and undecalcified histology to evaluate the rate and quality of bone formation and interbody fusion. RESULTS: Animals treated with the elastically deformable plate demonstrated statistically significantly superior early bone formation relative to the translationally dynamic plate. Trends in the data from 8 to 18 weeks postoperatively suggest that the elastically deformable implant enhanced bony bridging and fusion, but these enhancements were not statistically significant. CONCLUSIONS: Load-sharing through elastic micro-motion accelerates bone formation in the challenging goat ACDF model. The elastically deformable implant used in this study may promote early bony bridging and increased rates of fusion, but future studies will be necessary to comprehensively characterize the advantages of load-sharing through micro-motion.
BACKGROUND CONTEXT: Achieving a successful spinal fusion requires the proper biological and biomechanical environment. Optimizing load-sharing in the interbody space can enhance bone formation. For anterior cervical discectomy and fusion (ACDF), loading and motion are largely dictated by the stiffness of the plate, which can facilitate a balance between stability and load-sharing. The advantages of load-sharing may be substantial for patients with comorbidities and in multilevel procedures where pseudarthrosis rates are significant. PURPOSE: We aimed to evaluate the efficacy of a novel elastically deformable, continuously load-sharing anterior cervical spinal plate for promotion of bone formation and interbody fusion relative to a translationally dynamic plate. STUDY DESIGN/ SETTING: An in vivo animal model was used to evaluate the effects of an elastically deformable spinal plate on bone formation and spine fusion. METHODS: Fourteen goats underwent an ACDF and received either a translationally dynamic or elastically deformable plate. Animals were followed up until 18 weeks and were evaluated by plain x-ray, computed tomography scan, and undecalcified histology to evaluate the rate and quality of bone formation and interbody fusion. RESULTS: Animals treated with the elastically deformable plate demonstrated statistically significantly superior early bone formation relative to the translationally dynamic plate. Trends in the data from 8 to 18 weeks postoperatively suggest that the elastically deformable implant enhanced bony bridging and fusion, but these enhancements were not statistically significant. CONCLUSIONS: Load-sharing through elastic micro-motion accelerates bone formation in the challenging goatACDF model. The elastically deformable implant used in this study may promote early bony bridging and increased rates of fusion, but future studies will be necessary to comprehensively characterize the advantages of load-sharing through micro-motion.
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