Laser Marking of Spine Rods Is Strongly Associated With Risk of Clinical Rod Failure.

INTRODUCTION: What is overlooked in clinical studies are the possibilities of manufacturing and design aspects of the instrumentation that could initiate rod fracture. Although revision because of hardware fracture is a small fraction of the overall revision rates (12.1% to 13.7%), there are sufficient numbers of revision cases where hardware removed can undergo a thorough metallurgic analysis. This study is unique in that rod characteristics, such as alloy, surface markings, and fracture type, seen at fracture surfaces are considered in the analysis. METHODS: This work was conducted under both a retrospective and prospective IRB. Patients considered for this study were between the ages of 18 and 85 years who underwent or were undergoing revision spine surgery with previous instrumentation in the cervical, thoracic, or lumbar region and evidence of at least one of the following: catastrophic hardware failure, pseudarthrosis, implant loosening, or nonfusion. Inclusion criteria were determined through radiographic and medical records review. RESULTS: Fifty-six patients who had revision procedures because of different indications were included; 101 rods were removed, tested for fracture, and included in the analysis. Laser marking is significantly (P < 0.0001) associated with rod fracture. Detailed analysis showed notable surface and subsurface changes as the result of the marking, such as surface melting, cracking, and notching, creating locations to initiate a fracture. The three most informative variables to clinical rod fracture using multiple regression modeling were body mass index, presence or absence of laser mark (yes/no), and length of posterior fusion (≤2 spinal levels/>2 spinal levels). It was found that the relative risk of rod fracture is 23 times higher during 20 postoperative years than in cases with this index <0.4. DISCUSSION: For a patient with a given body mass index, if they require a multilevel fixation greater than two levels and rods with laser marks are used, the risk of early rod fracture increases by 40%.

Corrosion of Titanium Spinal Explants Is Similar to That Observed in Oil Field Line Pipe Steel: Evidence of Microbial-Influenced Corrosion In Vivo.

Current explanations of biomedical alloy degradation are focused on the physicochemical mechanisms of galvanic, pitting, crevice, and fretting corrosion. Ultimately, these studies dismiss the corrosion mechanism as a function of the local microbiome. Sixty spine hardware constructs were examined immediately after explantation for biofilm formation. Marked rod sections were imaged using scanning electron microscopy with energy dispersive x-ray spectroscopy. Backscatter mode was employed to better image the topology of the surface. There is clear differentiation between discoloration due to corrosion vs mechanical damage. Under scanning electron microscopy backscatter electron shadow examination, the authors noted that not all biofilm was removed using the surgical wipes. Corrosion pits were noticeably larger and numerous in areas of biofilm. In areas not associated with biofilms, there were few pits even if mechanical wear was evident. There is no evidence that the surface corrosion is modified between clinically diagnosed infected and noninfected patients. The surface damage present on explanted Ti6Al4V spine rods is uniquely similar to damage found in other industries where microbial-influenced corrosion is prevalent. Given that similar anaerobic, sulfur-reducing bacteria reside in and on human tissues, it is most likely that corrosion observed on explanted hardware is the result of microbial-influenced corrosion and not from inflammatory or other processes. Using analysis methods from other industries to characterize the microbiome present on explanted hardware is necessary. In so doing, a new definition of hardware-induced infection will be forthcoming. [Orthopedics. 2020;43(1):62-67.].

Three cases of metallosis associated with spine instrumentation.

The characteristic trait of metallosis is the presence of tissue staining. Analyzing explanted revision hardware from spine surgeries and performing ICPMS/AES analysis on removed tissue samples, a clinically relevant definition for metallosis may be developed. Results of the analysis identified hardware fretting wear and corrosion, and ICP-MS/AES analysis identified elevated metal ion concentrations in all cases. This supports the hypothesis that corrosion may be linked to poor health outcomes and potential need for revision surgery. Using failure analysis methods, corrosion products from orthopedic spine implants can be identified to begin to characterize metallosis in a clinically relevant manner. Failure analysis for patients undergoing revision spine surgery for other causes. Using failure analysis methods we conducted a retrieval analysis of explanted hardware and tissue. Implant failure with surrounding tissue metal staining is a current issue in the field of orthopedics. Specifically in spine, this issue is under reported and over looked as a clinically significant finding. Metallosis is most commonly used to describe the presence of tissue staining however this is not a clinically relevant definition. There is a need for further research to provide a better understanding of metallosis leading to better patient outcomes. Patients were screened for this study during a radiological review prior to surgery. All explanted hardware was documented and inspected for signs of wear and corrosion using non-destructive testing. A tissue sample that is normally removed and discarded was collected for ICP-MS/AES analysis. The presence of fretting corrosion, galling and corrosion fatigue was found on all explanted hardware. Cr levels are significantly higher than what was previously published as normal in muscle 0.03 µg/g. One case was a 4 order of magnitude elevation with the other 2 approximately 2 orders of magnitude increase. Titanium and Co concentrations are also significantly increased. The Ca to P ratio for all samples is approximately 1.7:1 suggesting some form of apatitic crystal present due to drying of the tissues. In all cases, the Al, Mo, V, Co, content in surrounding tissue is significantly elevated >10× above "normal," 8.4 ± 4.8; 1.61 ± 1.41; 0.06 ± 0.03; 1.35 ± 1.97 µg/g respectively. A "normal" reference titanium level could only be found for whole blood, 0.00072 ± 0.1412 µ/g. Iron and Ni measurements are within typical values presented in previous studies. No single mechanism for the release of metal ion in a patient is clear. Evidence suggests a tribocorrosive process due to both wear and environmental factors. Specific biologic mechanisms, such as the possible presence of bacteria may affect the fretting and corrosion of spinal instrumentation must be explored in conjunction with thorough review of patient outcomes. Such an effort can potentially reduce patient readmission and increase successful patient outcomes.

Spine rod straightening as a possible cause for revision.

In a previous study, the authors examined the elastic and short-term anelastic springback of Ti6Al4V, CoCrMoC and A316L stainless steel spine rods to observe how the rods mechanically respond in OR contouring. In that study rods were 200 mm long and only the movement at the tip was recorded. The implication of that work was that rods will straighten in-vivo, however, in order for the mechanism of straightening to be determined, the movement of individual bends over time must first be elucidated. Spine rods used were, commercially pure titanium (CP Ti) a primarily α-phase; Ti-6Al-4V; α/ß-phase titanium alloy from two different suppliers (denoted by, Ti-6Al-4V (L) and Ti-6Al-4V); ß-phase titanium (TNTZ) and CoCrMoC. Following contouring the rods were aged unconstrained, in normal atmosphere or simulated body fluid (SBF) in a CO2 incubator for up to 288 h. Elastic springback is significantly different between alloys with different microstructures. Both types of Ti6Al4V rods, while meeting the ASTM F136 industry standard, have significantly different properties, most importantly yield strength, flexural modulus, and springback. Environment showed no significant impact on anelasticity. The anelastic response of Ti6Al4V L sample, which has relatively more beta phase than the Ti6Al4V sample, follows the pure beta phase TNTZ in its extended time response. CoCrMoC and CP Ti have a very reduced anelastic response compared to the other alloys. This potentially can have unanticipated effects on the outcome of spine procedures, as the surgeon is reliant on the rods having similar properties to achieve a desired outcome.

Personalized implant for high tibial opening wedge: combination of solid freeform fabrication with combustion synthesis process.

In this work a new generation of bioceramic personalized implants were developed. This technique combines the processes of solid freeform fabrication (SFF) and combustion synthesis (CS) to create personalized bioceramic implants with tricalcium phosphate (TCP) and hydroxyapatite (HA). These porous bioceramics will be used to fill the tibial bone gap created by the opening wedge high tibial osteotomy (OWHTO). A freeform fabrication with three-dimensional printing (3DP) technique was used to fabricate a metallic mold with the same shape required to fill the gap in the opening wedge osteotomy. The mold was subsequently used in a CS process to fabricate the personalized ceramic implants with TCP and HA compositions. The mold geometry was designed on commercial 3D CAD software. The final personalized bioceramic implant was produced using a CS process. This technique was chosen because it exploits the exothermic reaction between P2O5 and CaO. Also, chemical composition and distribution of pores in the implant could be controlled. To determine the chemical composition, the microstructure, and the mechanical properties of the implant, cylindrical shapes were also fabricated using different fabrication parameters. Chemical composition was performed by X-ray diffraction. Pore size and pore interconnectivity was measured and analyzed using an electronic microscope system. Mechanical properties were determined by a mechanical testing system. The porous TCP and HA obtained have an open porous structure with an average 400 µm channel size. The mechanical behavior shows great stiffness and higher load to failure for both ceramics. Finally, this personalized ceramic implant facilitated the regeneration of new bone in the gap created by OWHTO and provides additional strength to allow accelerated rehabilitation.

Evaluation of spinal instrumentation rod bending characteristics for in-situ contouring.

Bending characteristics were studied in rods used for spinal instrumentation at in-situ contouring conditions. Five groups of five 6 mm diameter rods made from: cobalt alloy (VITALLIUM), titanium-aluminum-vanadium alloy (SDI™), ß-titanium alloy (TNTZ), cold worked stainless steel (STIFF), and annealed stainless steel (MALLEABLE) were studied. The bending procedure was similar to that typically applied for in-situ contouring in the operating room and included two bending cycles: first--bending to 21-24° under load with further release of loading for 10 min, and second--bending to 34-37° at the previously bent site and release of load for 10 min. Applied load, bending stiffness, and springback effect were studied. Statistical evaluation included ANOVA, correlation and regression analysis. TNTZ and SDI™ rods showed the highest (p < 0.05) springback at both bending cycles. VITALLIUM and STIFF rods showed mild springback (p < 0.05). The least (p < 0.05) springback was observed in the MALLEABLE rods. Springback significantly correlated with the bend angle under load (p < 0.001). To reach the necessary bend angle after unloading, over bending should be 37-40% of the required angle in TNTZ and SDI™ rods, 27-30% in VITALLIUM and STIFF rods, and around 20% in MALLEABLE rods.

Cellular response of titanium and its alloys as implants.

The cellular response of osteocytes to commercially pure titanium (α) and its alloys (α + ß and ß) has been tested in a culture media, and the results have been supplemented by analyses from various techniques such as inductively coupled plasma atomic emission spectroscopic (ICP-AES) analysis, X-ray photoemission spectroscopy (XPS), scanning electron microscopy (SEM), metallography, and electrochemical measurements. These results have been correlated with respect to the presence of various alloying elements in these alloys to qualify them for human application. The newer ß alloys have been examined for their potential use as implants. These results serve as a preliminary baseline to characterize the best alloy system for a comprehensive long-term investigation.

Gadolinium is detectable within the tissue of patients with nephrogenic systemic fibrosis.

BACKGROUND: Nephrogenic systemic fibrosis (NSF) is a disease of unknown etiology that affects a subset of patients with renal insufficiency. Recent publications suggested an association between exposure to gadolinium-containing contrast agents and subsequent development of NSF. We sought to detect gadolinium within the skin and soft tissue of patients with NSF who were exposed to gadolinium-based contrast. METHODS: Paraffin-embedded skin and soft tissue from NSF patients exposed to gadolinium, and from negative controls, was provided by the NSF Registry (New Haven, Conn). The tissue was searched for metals using a field emission scanning electron microscope that was equipped with energy dispersive spectroscopy. The presence of gadolinium and other metals was verified through identification of unique and requisite X-ray emission spectra. RESULTS: Gadolinium was detected in 4 of 13 tissue specimens from 7 patients with documented NSF who were exposed to gadolinium-based radiographic contrast. No gadolinium was detected in a paraffin-embedded specimen from a negative control. Based upon the known exposure history of patients with detectable gadolinium, a tissue residence time of 4 to 11 months was observed. LIMITATIONS: As this was a pilot investigation, only a single control specimen and a single histological section from each block of tissue were utilized. CONCLUSION: In this pilot investigation, gadolinium was detected in the tissue of a number of patients with NSF. Although neither dispositive of a pathophysiologic mechanism, nor proof of causation, the detection of gadolinium within tissue of NSF patients is supportive of an epidemiologic association between exposure to gadolinium-containing contrast material and development of disease.

Combustion synthesis of porous biomaterials.

This article discusses the unique material manufacturing process of self-propagating high temperature synthesis (SHS) as applied to the making of porous biomaterials. Porous materials have long been considered as the first step toward in-vivo bone tissue engineering and the creation of patient life-time implants. The authors have approached this challenge by utilizing combustion synthesis, to create novel materials such as NiTi + TiC as well as porous forms of materials that are commonly accepted for biomedical applications such as tricalcium phosphate and hydroxyapatite. In the SHS product, physico-chemical properties are controlled by, but not limited to, reactant stoichiometry; green density; particle size of the reactant mix; use or presence of a gasifying agent; heating rate of the reactants and gravity. By balancing these parameters, the energy of the reaction is controlled to create the desired product stoichiometry, porosity, and mechanical properties. SHS provides a means to rapidly manufacture materials, saving time and production costs as well as enabling the synthesis of custom devices through the use of individual molds. Mold materials can range from graphite to paper or paper machete. Combustion synthesis offers a method for the rapid manufacture of affordable, individual biomedical devices that will reduce patient recovery time.

Granulomatous reaction to titanium alloy: an unusual reaction to ear piercing.

A 68-year-old man presented with 4 firm, flesh-colored, and slightly erythematous nodules located on the superior pole and lobule of each ear. Although reluctant to provide details, it was discovered he had pierced his ears approximately 10 years earlier, and the nodules developed at the sites of the piercings. Keloids were suggested clinically and the lesions were excised. Microscopic examination demonstrated epithelialized tracts surrounded by a granulomatous infiltrate of macrophages, lymphocytes, and plasma cells. Closer examination revealed minute brown-black particles within macrophages. Dark-field microscopy confirmed the metallic nature of the particles. Environmental scanning electron microscopy with energy dispersive spectroscopy revealed the particles to be composed of titanium, aluminum, and vanadium. It would appear that in rare circumstances titanium alloy used in body piercing may engender a granulomatous dermatitis. The rarity of such a response to titanium alloy is discussed and the literature appraised.

Bone development and age-related bone loss in male C57BL/6J mice.

The objective of this study was to examine changes in the long bones of male C57BL/6J mice with growth and aging, and to consider the applicability of this animal for use in studying Type II osteoporosis. Male C57BL/6J mice were aged in our colony between 4 and 104 weeks (n=9-15/group). The right femur and humeri were measured for length and subjected to mechanical testing (3-point flexure) and compositional analysis. The left femurs were embedded and thick slices at the mid-diaphysis were assessed for morphology, formation indices, and bone structure. In young mice, rapid growth was marked by substantial increases in bone size, mineral mass, and mechanical properties. Maturity occurred between 12 and 42 weeks of age with the maintenance of bone mass and mechanical properties. From peak levels, mice aged for 104 weeks experienced decreased whole femur mass (12.1 and 18.6% for dry and ash mass, respectively), percentage mineralization (7.4%), diminished whole bone stiffness (29.2%), energy to fracture (51.8%), and decreased cortical thickness (20.1%). Indices of surface-based formation decreased rapidly from the onset of the study. However, the periosteal perimeter and, consequently, the cross-sectional moments of inertia continued to increase through 104 weeks, thus maintaining structural properties. This compensated for cortical thinning and increased brittleness due to decreased mineralization and stiffness. The shape of the mid-diaphysis became increasingly less elliptical in aged mice, and endocortical resorption and evidence of subsequent formation were present in 20-50% of femurs aged > or =78 weeks. This, combined with the appearance of excessive endocortical resorption after 52 weeks, indicated a shift in normal mechanisms regulating bone shape and location, and was suggestive of remodeling. The pattern of bone loss at the femoral mid-diaphysis in this study is markedly similar to that seen in cortical bone in the human femoral neck in Type II osteoporosis. This study has thus demonstrated that the male C57BL/6J mouse is a novel and appropriate model for use in studying endogenous, aging-related osteopenia and may be a useful model for the study of Type II osteoporosis.