Early bone ingrowth and segmental stability of a trussed titanium cage versus a polyether ether ketone cage in an ovine lumbar interbody fusion model.

BACKGROUND CONTEXT: Lumbar interbody fusion is an effective treatment for unstable spinal segments. However, the time needed to establish a solid bony interbody fusion between the two vertebrae may be longer than twelve months after surgery. During this time window, the instrumented spinal segment is assumed to be at increased risk for instability related complications such as cage migration or subsidence. It is hypothesized that the design of new interbody cages that enable direct osseointegration of the cage at the vertebral endplates, without requiring full bony fusion between the two vertebral endplates, might shorten the time window that the instrumented spinal segment is susceptible to failure. PURPOSE: To quantify the bone ingrowth and resulting segmental stability during consolidation of lumbar interbody fusion using two different cage types. STUDY DESIGN: Preclinical ovine model. METHODS: Seven skeletally mature sheep underwent bi-segmental lumbar interbody fusion surgery with one conventional polyether ether ketone (PEEK) cage, and one newly developed trussed titanium (TT) cage. After a postoperative time period of 13 weeks, non-destructive range of motion testing, and histologic analysis was performed. Additionally, sample specific finite element (FE) analysis was performed to predict the stability of the interbody fusion region alone. RESULTS: Physiological movement of complete spinal motion segments did not reveal significant differences between the segments operated with PEEK and TT cages. The onset of creeping substitution within the cage seemed to be sooner for PEEK cages, which led to significantly higher bone volume over total volume (BV/TV) compared with the TT cages. TT cages showed significantly more direct bone to implant contact (BIC). Although the mean stability of the interbody fusion region alone was not statistically different between the PEEK and TT cages, the variation within the cage types illustrated an all-or-nothing response for the PEEK cages while a more gradual increase in stability was found for the TT cages. CONCLUSIONS: Spinal segments operated with conventional PEEK cages were not different from those operated with newly developed TT cages in terms of segmental stability but did show a different mechanism of bone ingrowth and attachment. Based on the differences in development of bony fusion, we hypothesize that TT cages might facilitate increased early segmental stability by direct osseointegration of the cage at the vertebral endplates without requiring complete bony bridging through the cage. CLINICAL SIGNIFICANCE: Interbody cage type affects the consolidation process of spinal interbody fusion. Whether different consolidation processes of spinal interbody fusion result in clinically significant differences requires further investigation.

Local bone metabolism during the consolidation process of spinal interbody fusion.

INTRODUCTION: Although computed tomography (CT) can identify the presence of eventual bony bridges following lumbar interbody fusion (LIF) surgery, it does not provide information on the ongoing formation process of new bony structures. 18F sodium fluoride (18F-NaF) positron emission tomography (PET) could be used as complementary modality to add information on the bone metabolism at the fusion site. However, it remains unknown how bone metabolism in the operated segment changes early after surgery in uncompromised situations. This study aimed to quantify the changes in local bone metabolism during consolidation of LIF. MATERIALS AND METHODS: Six skeletally mature sheep underwent LIF surgery. 18F-NaF PET/CT scanning was performed 6 and 12 weeks postoperatively to quantify the bone volume and metabolism in the operated segment. Bone metabolism was expressed as a function of bone volume. RESULTS: Early in the fusion process, bone metabolism was increased at the endplates of the operated vertebrae. In a next phase, bone metabolism increased in the center of the interbody region, peaked, and declined to an equilibrium state. During the entire postoperative time period of 12 weeks, bone metabolism in the interbody region was higher than that of a reference site in the spinal column. CONCLUSION: Following LIF surgery, there is a rapid increase in bone metabolism at the vertebral endplates that develops towards the center of the interbody region. Knowing the local bone metabolism during uncompromised consolidation of spinal interbody fusion might enable identification of impaired bone formation early after LIF surgery using 18F-NaF PET/CT scanning.

Assessment of Growth Reduction of Five Clinical Pathogens by Injectable S53P4 Bioactive Glass Material Formulations.

The one-stage treatment of chronic osteomyelitis with S53P4 bioactive glass (BAG) granules has shown excellent results. However, these granules possess suboptimal handling properties. Therefore, new injectable S53P4 putty materials have been developed by the incorporation of a synthetic binder to contain glass granules. The goal of the current study was to assess their potential to eradicate five clinically relevant pathogens: methicillin sensitive Staphylococcus aureus (MSSA), methicillin resistant Staphylococcus aureus (MRSA), Enterococcus coli (E. coli), Enterococcus faecalis (E. faecalis), and Pseudomonas aeruginosa (P. aeruginosa). As a control, S53P4 granules (500-800 µm) and S66 glass (< 45 µm) were used. To evaluate the antimicrobial properties, the materials were cultured with the pathogens in a Müller-Hinton II broth for a week with daily colony forming unit (CFU) counting. One of the tested putty formulations was observed to reduce the number of CFU/mL compared to a negative control (no material, only pathogen in broth) for E. coli, E. faecalis and P. aeruginosa. However, none of the tested putty formulations was able to completely eradicate the pathogens in the broths, which would be needed for safe infection treatment. The results obtained for the control materials were unexpected. S66 glass showed full eradication of P. aeruginosa and reduced the number of CFUs of other pathogens, while the S53P4 granules did not show eradication. The observations on the loose S53P4 granules in this study contradict available literature, which needs further investigation. The results obtained in this study also stretch the importance for a better understanding of the underlying antimicrobial mechanism of S53P4 BAG and how this is related to the dosage. In addition, it should be elucidated how these antimicrobial properties are affected by changes in the material formulation, for example by addition of binders to improve the handling properties or by changing the surface area.

Heparin release from slippery-when-wet guide wires for intravascular use.

Thin metallic wires with an adherent hydrophilic/ lubricious polymeric coating were manufactured in a new extrusion-like procedure. This procedure is part of a novel and efficient way of assembling lubricious guide wires for intravascular interventions, such as percutaneous transluminal angioplasty. It is reported that heparin can readily be incorporated in the hydrophilic coating. A set of heparin-containing guidewire models was made and studied in detail. This showed that (i). immersion of the guide-wire models in an aqueous environment leads to release of heparin from their surface; (ii). the presence of heparin in the coating does not impede the lubricity of the coils; (iii). addition of stearic acid in the coating, next to heparin, does not influence the lubricity of the guide-wire models. Two different charges of heparin (designated heparin-low and heparin-high) were incorporated in the coating. It is discussed that release of heparin from the surface of medical devices (e.g. guide wires and catheters) is much more effective than systemic heparinization, basically because dissolved heparin molecules have a much larger probability of simply passing a medical device's surface (axial convection) rather than contacting it (radial diffusion).