Robust Nanofiber Mats Exfoliated From Tussah Silk for Potential Biomedical Applications

Nanofibers as elements for bioscaffolds are pushing the development of tissue engineering. In this study, tussah silk was mechanically disintegrated into nanofibers dispersed in aqueous solution which was cast to generate tussah silk fibroin (TSF) nanofiber mats. The effect of treatment time on the morphology, structure, and mechanical properties of nanofiber mats was examined. SEM indicated decreasing diameter of the nanofiber with shearing time, and the diameter of the nanofiber was 139.7 nm after 30 min treatment. These nanofiber mats exhibited excellent mechanical properties; the breaking strength increased from 26.31 to 72.68 MPa with the decrease of fiber diameter from 196.5 to 139.7 nm. The particulate debris was observed on protease XIV degraded nanofiber mats, and the weight loss was greater than 10% after 30 days in vitro degradation. The cell compatibility experiment confirmed adhesion and spreading of NIH-3T3 cells and enhanced cell proliferation on TSF nanofiber mats compared to that on Bombyx mori silk nanofiber mats. In conclusion, results indicate that TSF nanofiber mats prepared in this study are mechanically robust, slow biodegradable, and biocompatible materials, and have promising application in regenerative medicine.

Post-Processing and Surface Characterization of Additively Manufactured Stainless Steel 316L Lattice: Implications for BioMedical Use

Additive manufacturing of stainless steel is becoming increasingly accessible, allowing for the customisation of structure and surface characteristics; there is little guidance for the post-processing of these metals. We carried out this study to ascertain the effects of various combinations of post-processing methods on the surface of an additively manufactured stainless steel 316L lattice. We also characterized the nature of residual surface particles found after these processes via energy-dispersive X-ray spectroscopy. Finally, we measured the surface roughness of the post-processing lattices via digital microscopy. The native lattices had a predictably high surface roughness from partially molten particles. Sandblasting effectively removed this but damaged the surface, introducing a peel-off layer, as well as leaving surface residue from the glass beads used. The addition of either abrasive polishing or electropolishing removed the peel-off layer but introduced other surface deficiencies making it more susceptible to corrosion. Finally, when electropolishing was performed after the above processes, there was a significant reduction in residual surface particles. The constitution of the particulate debris as well as the lattice surface roughness following each post-processing method varied, with potential implications for clinical use. The work provides a good base for future development of post-processing methods for additively manufactured stainless steel.

Particulate Debris Released From Breast Implant Surfaces Are Highly Dependent on Implant Type

Background While Breast Implants (BIs) have never been safer, factors such as implant debris may influence complications such as chronic inflammation and illness such as ALCL. Do different types of BIs produce differential particulate debris? Objectives Our objective was to quantify, investigate and characterize the size, amount, and material-type of both loosely bound and adherent surface particles, using five different surface types of commercial BIs. Methods Surface particles from 5 surface types of BIs (n=5/group); Biocell, Microcell, Siltex, Smooth, SmoothSilk, and Traditional-Smooth were: 1) removed by a rinsing procedure and 2) removed using ultrapure-adhesive carbon-tabs. Particles were characterized (ASTM 1877-16) using Scanning-Electron-Microscopy and EDX-chemical analysis. Results Particles rinsed from Biocell, Microcell and Siltex were <1 micron in diameter while SmoothSilk and Traditional-Smooth surfaces had median sizes >1micron (range: 0.4-2.7microns). The total mass of particles rinsed from the surfaces indicated Biocell had >5 fold-more particulate compared to all other implants, and >30 fold-more than SmoothSilk or Traditional-Smooth implants (>100x more for post rinse adhesion analysis). EDX analysis indicated particulate material for Biocell, Microcell and Siltex was silicone (>50%), while particulate from SmoothSilk and Traditional-Smooth implants were predominantly carbon-based polymers, eg, polycarbonate-urethane, consistent with packaging (and were detected on all implant types). Generally, SmoothSilk and Traditional-Smooth implant groups had >10x fewer particles released than Biocell, Microcell and Siltex surfaces. Pilot ex-vivo tissue analysis supported these findings. Conclusions Particulate debris released from BIs are highly dependent on the type of implant surface and is a likely key determinant of in vivo performance.

Validation of revision data for total hip and knee replacements undertaken at a high volume orthopaedic centre against data held on the National Joint Registry

Background With over 2.35 million records, the National Joint Registry (NJR) is the largest arthroplasty registry in the world. It provides a powerful tool to monitor implant survivorship and influence different surgical strategies. To date, little work has been undertaken to investigate the validity of the ‘Reason for Revision’ recorded in Consultant Outcome Reports on the NJR. Methods The NJR was queried to identify all revisions on the THR performed at a single centre over an 11-year period. Review and validation of ‘Reason for Revision’ for each case was undertaken using radiological imaging studies, pathology, histology, microbiology and electronic medical records. Results Of the 22,046 primary total hip replacements (THR) and total knee replacements (TKR) undertaken by 23 surgeons at our hospital, over an 11-year period, 1.35% (297) were subsequently reported to the NJR as revised. Discrepancies in reporting to the NJR were identified for 41 cases (25.63%) for THR and 28 (20.40%) cases for TKR. Revision for infection was under-reported for both THR and TKR by 1.88% and 3.65% respectively. Reporting of adverse soft tissue reaction to particulate debris for THR was unreported by 11%. Progressive arthritis following a TKR was unreported by 6.56%. All the cases reported as ‘other’ (8.75% for THRs and 3.65% for TKRs) were reclassified to the most appropriate ‘reason for revision’ category. The ‘reason for revision’ data is recorded to the NJR with findings at the time of surgery. It is some days before microbiology and histology reports become available and source data is not always updated. Conclusion If an average of 23% wrong data entry at a highly organised institution is replicated throughout the UK, a formal process to validate primary and revision data submitted to the NJR should be considered. Local scrutiny, review and validation of revision data are all vital to optimise the value of the NJR. Accurate data recorded to the NJR is imperative to provide safe and effective improvements in orthopaedic surgery.

The effect of implant modification

Aims The aim of this study was to conduct the largest low contact stress (LCS) retrieval study to elucidate the failure mechanisms of the Porocoat and Duofix femoral component. The latter design was voluntarily recalled by the manufacturer. Materials and Methods Uncemented LCS explants were divided into three groups: Duofix, Porocoat, and mixed. Demographics, polyethylene wear, tissue ingrowth, and metallurgical analyses were performed. Results In 104 implants, a decrease in the odds of loosening and an increase in metallosis and tissue staining in the Duofix group relative to Porocoat group was detected (p = 0.028). There was an increased presence of embedded metallic debris in the Duofix group (p < 0.001). Decreased tissue ingrowth was associated with the Duofix surface (p < 0.001). The attached beads had reduced microhardness, indicative of adverse thermal processing, which resulted in bead shedding, particulate debris, and metallosis. Conclusion Hydroxyapatite coating of the LCS femoral component produced unexpected results and led to its recall. The root cause was likely a combination of retained alumina grit and a reduction in bead microhardness (mechanical strength) resulting in increased particle debris, metallosis, and early revision. The Duofix LCS femoral component was not equivalent to the Porocoat version despite its approval through the Food and Drug Administration (FDA) 510(k) equivalance approval process. Regulation of the introduction of modified existing devices needs to be improved and the Duofix LCS should have been considered to be a new device for which equivalence had not been demonstrated at the point of introduction. Cite this article: Bone Joint J 2019;101-B:1248–1255

Air bubbles are released by thoracic endograft deployment: An in vitro experimental study

Purpose: Embolic stroke is a dreaded complication of thoracic endovascular aortic repair. The prevailing theory about its cause is that particulate debris from atherosclerotic lesions in the aortic wall are dislodged by endovascular instruments and embolize to the brain. An alternative source of embolism might be air trapped in the endograft delivery system. The aim of this experimental study was to determine whether air is released during deployment of a thoracic endograft. Methods: In an experimental benchtop study, eight thoracic endografts (five Medtronic Valiant Thoracic and three Gore TAG) were deployed in a water-filled transparent container drained from air. Endografts were prepared and deployed according to their instructions for use. Deployment was filmed and the volume of air released was collected and measured in a calibrated syringe. Results: Air was released from all the endografts examined. Air volumes ranged from 0.1 to 0.3 mL for Medtronic Valiant Thoracic and from <0.025 to 0.04 mL for Gore TAG. The largest bubbles had a diameter of approximately 3 mm and came from the proximal end of the Medtronic Valiant device. Conclusion: Air bubbles are released from thoracic endografts during deployment. Air embolism may be an alternative cause of stroke during thoracic endovascular aortic repair.