Both groups were also comparable in terms of baseline diagnosis (herniated disc, spondylosis, or both) and number of levels operated (one, two, three, or four). The PEMF and control groups were comparable with regard to age, gender, race, past medical history, smoking status, and litigation status. Follow-up was carried out at 1, 2, 3, 6, and 12 months postoperatively. Postoperative care was otherwise identical. Patients were randomly assigned to one of two groups: those receiving PEMF stimulation after surgery (PEMF group, 163 patients) and those not receiving PEMF stimulation (control group, 160 patients). Adverse events were reported by all patients throughout the study to determine device safety. Two orthopedic surgeons not otherwise affiliated with the study and blinded to treatment group evaluated the radiographs, as did a blinded radiologist. Measurements were obtained preoperatively and at each postoperative interval and included neurologic assessment, visual analog scale (VAS) scores for shoulder/arm pain at rest and with activity, SF-12 scores, the neck disability index (NDI), and radiographs (anteroposterior, lateral, and flexion-extension views). Allograft bone and an anterior cervical plate were used in all cases. All patients underwent ACDF using the Smith-Robinson technique. The patients were either smokers (more than one pack per day) and/or were undergoing multilevel fusions. Three hundred and twenty-three patients with radiographic evidence (computed tomography-myelogram or magnetic resonance imaging ) of a compressed cervical nerve root and symptomatic radiculopathy appropriate to the compressed root that had failed to respond to nonoperative management were enrolled in the study. To determine the efficacy and safety of PEMF stimulation as an adjunct to arthrodesis after ACDF in patients with potential risk factors for nonunion.Ī randomized, controlled, prospective multicenter clinical trial. Pulsed electromagnetic field (PEMF) stimulation has been shown to increase arthrodesis rates after lumbar spine fusion surgery, but there are minimal data concerning the effect of PEMF stimulation on cervical spine fusion. Multilevel fusions, the use of allograft bone, and smoking have been associated with an increased risk of nonunion after anterior cervical discectomy and fusion (ACDF) procedures. Conclusion: The study shows that the Ti-PEEK surface demonstrated enhanced osseointegrative properties compared to PEEK both in vitro and in vivo. Similarly, a significant increase in new bone formation, bony apposition, and pullout strength was demonstrated on Ti-PEEK implants when compared to PEEK implants at 12 and 24 weeks in an ovine implant in vivo model. Results: Osteoblast-like cells attached to the Ti-PEEK surface upregulated early bone-forming activity as measured by an increase in transcription and translation of ALP and BMP-2 when compared to cells on PEEK. Materials and methods: The influence of the Ti-PEEK surface modification on the biochemical, biomechanical, and histological properties at the bone–implant interface is demonstrated both in vitro using simulated bone-forming cell culture experiments and in vivo using a 12-and 24-week ovine implant model. The purpose of this study was to evaluate the in vitro and in vivo osteoblast cell–implant surface interactions that result in osseointegration onto a surface composed of plasma-sprayed titanium on a polyetheretherketone (PEEK) substrate or titanium-coated PEEK (Ti-PEEK) (PlasmaporeXP®) as compared to uncoated PEEK implants. These cellular interactions are dependent on how the implant surface enables the coating and binding of blood and tissue fluid proteins that support cell adhesion. For such an implant, cells must be able to attach, move, grow, and differentiate on its surface. Spinal interbody fusion cages are designed to provide immediate stabilization for adjoining vertebrae and ideally enable bony ingrowth to achieve successful integration.
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