The World's First Implantation of a Personalized Microporous Titanium Sternum with Motile Costal Clip Connections: A Case Report.

Extensive chest wall defects occur in 28% of all sternal resection cases and are a major challenge in thoracic surgery. These cases are generally considered "critical defects" requiring primary or secondary reconstruction using various types of flaps, mesh repairs, bone autografts, or endoprosthesis. The past decade witnessed rapid advances in the application of personalized endoprostheses in thoracic surgery. Surgeons began to use carbon or titanium grafts for personalized sternum replacement. The main advantages of these implants are superior cosmetic effect, biocompatibility, and low risk of infection. Herein, we present a case of a 55-year-old patient with an indication for extended sternum resection due to metastatic thyroid cancer. The patient underwent extended sternum resection, followed by the implantation of a personalized microporous titanium sternum equipped with graspers for atraumatic rib fixation.

Plasma Polishing as a New Polishing Option to Reduce the Surface Roughness of Porous Titanium Alloy for 3D Printing.

Porous titanium alloy implants with simulated trabecular bone fabricated by 3D printing technology have broad prospects. However, due to the fact that some powder adheres to the surface of the workpiece during the manufacturing process, the surface roughness in direct printing pieces is relatively high. At the same time, since the internal pores of the porous structure cannot be polished by conventional mechanical polishing, an alternative method needs to be found. As a surface technology, plasma polishing technology is especially suitable for parts with complex shapes that are difficult to polish mechanically. It can effectively remove particles and fine splash residues attached to the surface of 3D printed porous titanium alloy workpieces. Therefore, it can reduce surface roughness. Firstly, titanium alloy powder is used to print the porous structure of the simulated trabecular bone with a metal 3D printer. After printing, heat treatment, removal of the supporting structure, and ultrasonic cleaning is carried out. Then, plasma polishing is performed, consisting of adding a polishing electrolyte with the pH set to 5.7, preheating the machine to 101.6 °C, fixing the workpiece on the polishing fixture, and setting the voltage (313 V), current (59 A), and polishing time (3 min). After polishing, the surface of the porous titanium alloy workpiece is analyzed by a confocal microscope, and the surface roughness is measured. Scanning electron microscopy is used to characterize the surface condition of porous titanium. The results show that the surface roughness of the whole porous titanium alloy workpiece changed from Ra (average roughness) = 126.9 µm to Ra = 56.28 µm, and the surface roughness of the trabecular structure changed from Ra = 42.61 µm to Ra = 26.25 µm. Meanwhile, semi-molten powders and ablative oxide layers are removed, and surface quality is improved.

Point-of-care antimicrobial coating protects orthopaedic implants from bacterial challenge.

Implant related infections are the most common cause of joint arthroplasty failure, requiring revision surgeries and a new implant, resulting in a cost of $8.6 billion annually. To address this problem, we created a class of coating technology that is applied in the operating room, in a procedure that takes less than 10 min, and can incorporate any desired antibiotic. Our coating technology uses an in situ coupling reaction of branched poly(ethylene glycol) and poly(allyl mercaptan) (PEG-PAM) polymers to generate an amphiphilic polymeric coating. We show in vivo efficacy in preventing implant infection in both post-arthroplasty infection and post-spinal surgery infection mouse models. Our technology displays efficacy with or without systemic antibiotics, the standard of care. Our coating technology is applied in a clinically relevant time frame, does not require modification of implant manufacturing process, and does not change the implant shelf life.

An integrated benefit-risk assessment of cobalt-containing alloys used in medical devices: Implications for regulatory requirements in the European Union.

In 2017, the European Union (EU) Committee for Risk Assessment (RAC) recommended the classification of metallic cobalt (Co) as Category 1B with respect to its carcinogenic and reproductive hazard potential and Category 2 for mutagenicity but did not evaluate the relevance of these classifications for patients exposed to Co-containing alloys (CoCA) used in medical devices. CoCA are inherently different materials from Co metal from a toxicological perspective and thus require a separate assessment. CoCA are biocompatible materials with a unique combination of properties including strength, durability, and a long history of safe use that make them uniquely suited for use in a wide-range of medical devices. Assessments were performed on relevant preclinical and clinical carcinogenicity and reproductive toxicity data for Co and CoCA to meet the requirements under the EU Medical Device Regulation triggered by the ECHA re-classification (adopted in October 2019 under the 14th Adaptation to Technical Progress to CLP) and to address their relevance to patient safety. The objective of this review is to present an integrated overview of these assessments, a benefit-risk assessment and an examination of potential alternative materials. The data support the conclusion that the exposure to CoCA in medical devices via clinically relevant routes does not represent a hazard for carcinogenicity or reproductive toxicity. Additionally, the risk for the adverse effects that are known to occur with elevated Co concentrations (e.g., cardiomyopathy) are very low for CoCA implant devices (infrequent reports often reflecting a unique catastrophic failure event out of millions of patients) and negligible for CoCA non-implant devices (not measurable/no case reports). In conclusion, the favorable benefit-risk profile also in relation to possible alternatives presented herein strongly support continued use of CoCA in medical devices.

Earfold™: A combined approach with conchal bowl reduction.

BACKGROUND: Prominent ear deformity is common amongst the human population and is partly due to underdevelopment of the antihelical fold, a prominent conchal bowl, or both. Recently, the senior author described a minimally invasive technique for changing the shape of the antihelical fold using the Earfold™ implant (Allergan plc, Dublin, Ireland). However, there is still a paucity of data regarding outcomes from combing this approach with surgical techniques to correct conchal bowl hypertrophy. OBJECTIVES AND METHODS: Questionnaire-based study evaluating outcomes in consecutive patients undergoing treatment with Earfold™ and conchal bowl reduction. Patient reported outcome measures were assessed with a validated questionnaire. Data on complications were obtained from the patient's case notes and free-text sections of the questionnaire. RESULTS: Completed questionnaires were received from 8 patients out of a total of 18 who underwent the combination treatment (44% response rate). Statistically significant differences were noted in nearly all questions (18/19) relating to changes in ear appearance as a result of the surgery, with all patients being satisfied following the combined procedure. Improvements in subjective outcomes were compared to previous studies evaluating treatment with Earfold™. CONCLUSIONS: The Earfold™ implant can be combined safely with other otoplasty techniques to achieve a good outcome in a carefully selected patient population.

Analytical Problems with Preparation of Paraspinal Tissues from Patients with Spinal Fusion for Analysis of Titanium.

Preparation of paraspinal tissue of patients with implants for elemental analysis is a challenge because it contains titanium in the ionic form, as well as metallic debris. Most literature reports focus on dissolving the tissue, but the impact of digestion conditions on metallic debris of Ti has not been investigated. In our work, various digestion conditions, including systems, compositions of oxidising mixture, and time, were tested aiming (i) to digest the tissue without digestion of metallic titanium to quantify soluble Ti and (ii) to digest metallic titanium debris to asses total Ti content in tissue. The experiments were performed in a closed mode using a microwave-assisted system and a carbon heating block. Our study revealed that total digestion of titanium was impossible in the tested conditions and the maximal level of digested titanium was below 70%. The mineralisation with the use of concentrated nitric acid was optimal to prepare paraspinal samples to analyse the soluble titanium form because metallic titanium passivated and did not migrate to the solution. The elaborated conditions were applied to determine titanium ion in the periimplant tissue of patients with three different titanium-based surgical systems, including traditional growing rod (TGR), guided growth systems (GGS), and vertical expandable prosthesis titanium rib (VEPTR).

Security and reliability of CUSTOMBONE cranioplasties: A prospective multicentric study.

BACKGROUND: Repairing bone defects generated by craniectomy is a major therapeutic challenge in terms of bone consolidation as well as functional and cognitive recovery. Furthermore, these surgical procedures are often grafted with complications such as infections, breaches, displacements and rejections leading to failure and thus explantation of the prosthesis. OBJECTIVE: To evaluate cumulative explantation and infection rates following the implantation of a tailored cranioplasty CUSTOMBONE prosthesis made of porous hydroxyapatite. One hundred and ten consecutive patients requiring cranial reconstruction for a bone defect were prospectively included in a multicenter study constituted of 21 centres between December 2012 and July 2014. Follow-up lasted 2 years. RESULTS: Mean age of patients included in the study was 42±15 years old (y.o), composed mainly by men (57.27%). Explantations of the CUSTOMBONE prosthesis were performed in 13/110 (11.8%) patients, significantly due to infections: 9/13 (69.2%) (p<0.0001), with 2 (15.4%) implant fracture, 1 (7.7%) skin defect and 1 (7.7%) following the mobilization of the implant. Cumulative explantation rates were successively 4.6% (SD 2.0), 7.4% (SD 2.5), 9.4% (SD 2.8) and 11.8% (SD 2.9%) at 2, 6, 12 and 24 months. Infections were identified in 16/110 (14.5%): 8/16 (50%) superficial and 8/16 (50%) deep. None of the following elements, whether demographic characteristics, indications, size, location of the implant, redo surgery, co-morbidities or medical history, were statistically identified as risk factors for prosthesis explantation or infection. CONCLUSION: Our study provides relevant clinical evidence on the performance and safety of CUSTOMBONE prosthesis in cranial procedures. Complications that are difficulty incompressible mainly occur during the first 6 months, but can appear at a later stage (>1 year). Thus assiduous, regular and long-term surveillances are necessary.

A new valid Walking Aid Scale better predicts distance walked by prosthesis users than Prosthetic Mobility Questionnaire 2.0 and Activities-Specific Balance Confidence Scale.

The availability of psychometrically-sound and parsimonious outcome measures is key for optimizing decision-making about prosthetic fitting and rehabilitation in lower limb prosthesis users. Despite the increasing clinical use of observational and self-reported scales for assessing mobility and balance, there is currently no scale that accounts for the use of assistive devices while walking under conditions of increasing difficulty. Therefore, the purpose of this study was to develop and validate a Walking Aid Scale (WAS) in a cross-sectional sample of 144 prosthesis users. Specifically, we examined internal consistency and concurrent validity of WAS against two commonly used self-report measures of prosthetic mobility and balance confidence - the Prosthetic Mobility Questionnaire 2.0 (PMQ 2.0) and Activities-Specific Balance Confidence Scale (ABC-5). The predictive value of WAS, in comparison to PMQ 2.0 and ABC-5, was assessed using a 6-Minute Walk Test (6MWT) and participants' characteristics. The WAS showed significant moderate-to-good correlations with PMQ 2.0 and ABC-5, and all scales correlated well with age and 6MWT. Participants who relied less on walking aids reported higher mobility levels, greater balance confidence, and walked longer distances. Age was associated with greater use of walking aids and lower mobility and balance confidence. In the stepwise linear regression analysis, age, amputation level, time since amputation, and WAS predicted about two-thirds of the variability in 6MWT with no significant contribution of PMQ 2.0 and ABC-5. These findings indicate that WAS is a valid instrument and a better predictor of walking distance than PMQ 2.0 and ABC-5 in the lower limb prosthesis users.

Perfusion promotes endothelialized pore formation in high concentration fibrin gels otherwise unsuitable for tube development.

Vascularization of tissue engineered implants is crucial for their survival and integration in the recipient's body. Pre-vascularized, fibrin-based implants offer a solution since low concentration fibrin hydrogels (1 mg/mL) have been shown to promote tube formation of endothelial cells in co-culture with adipogenic stem cells. However, higher fibrinogen concentrations (> 20 mg/mL) enabling the fabrication of stable implants are necessary.We here characterized fibrin gels of 1-30 mg/mL for their rheological properties and whether they support tube formation of endothelial cell-adipogenic stem cell co-cultures for up to 7 days. Moreover, 20 mg/mL gels containing preformed channels and endothelial cell-adipogenic stem cell co-culture were perfused continuously in a customized flow chamber with 3.9 dyn/cm2 for 12 days and analyzed for capillary formation.Rheology of fibrin gels showed increasing stability proportional to fibrinogen concentration with 20 mg/mL gels having a storage module of 465 Pa. Complex tube networks stable for 7 days were observed at 1-5 mg/mL gels whereas higher concentrations showed initial sprouting only. However, perfusion of 20 mg/mL fibrin gels resulted in endothelialized pore formation in several layers of the gel with endothelial cell-adipogenic stem cell co-culture.Thus, perfusion supports the formation of capillary-like structures in fibrin gels that are too dense for spontaneous tube formation under static conditions. Future studies are necessary to further increase pore density and to investigate proper nutrition of tissue-specific target cells in the scaffold.

Availability of totally implantable venous access devices in cancer patients is high in the long term: a seven-year follow-up study.

PURPOSE: Totally implantable venous access devices (TIVADs) currently have an important place in medical oncology practice; however, their long-term availability deserves further investigation, since they are usually required by patients for prolonged periods. This study aimed to evaluate long-term availability of TIVADs in adult cancer patients, in conjunction with complication/removal rates over time and associated risk factors during 7-year follow-up. METHODS: A total of 204 adult cancer patients who underwent TIVAD placement via subclavian vein using the Seldinger technique were included in this study. Medical data and catheter follow-up records were investigated retrospectively. Complications and port removals due to complications were evaluated over time. RESULTS: During median 21.9 (range, 0.7-82.9) months of follow-up, great majority of the patients did not require catheter removal due to complications (91.7%). During a total follow-up of 183,328 catheter days, 20 (9.8%) patients had complications with an incidence of 0.109 cases per 1000 catheter days and 18 (8.8%) of them required TIVAD removal (0.098 cases per 1000 catheter days). Most device removals due to complications (15/18, 83.3%) occurred within the first 24 months. Multivariate analysis identified left-sided device location as the only significant independent predictor of short device availability (OR, 3.5 [95% CI, 1.1-11.1], p = 0.036). CONCLUSION: TIVADs in cancer patients appear to be safe and their availability appears to be high in the long term. A decision for early removal might be revisited. Opting for the accustomed side (right side in the present study) for implantations seems to be associated with better outcomes.

Load Sharing and Endplate Pressure Distribution in Anterior Interbody Fusion Influenced by Graft Choice.

BACKGROUND: Cage subsidence is a known complication of spinal fusion. Various aspects of cage design have been investigated for their influence on cage subsidence, whereas the potential contribution of graft material to load sharing is often overlooked. We aimed to determine whether graft in the aperture affects endplate pressure distribution. METHODS: The pressure distributions of a polyetheretherketone interbody cage with 3 different aperture graft conditions were evaluated: empty, demineralized bone matrix, and supercritical CO2-treated allograft bone crunch (SCCO2). RESULTS: Graft materials contributed as much as half the load transmission for SCCO2, whereas demineralized bone matrix contributed one third. Endplate areas in contact with the cage demonstrated decreased areas within the highest-pressure spectrum with SCCO2 graft materials compared with empty cages. CONCLUSIONS: Graft choice plays a role in reducing peak endplate pressures. This finding is relevant to implant subsidence, as well as graft loading and remodeling.

Chronic Use of a Sensitized Bionic Hand Does Not Remap the Sense of Touch.

Electrical stimulation of tactile nerve fibers that innervated an amputated hand results in vivid sensations experienced at a specific location on the phantom hand, a phenomenon that can be leveraged to convey tactile feedback through bionic hands. Ideally, electrically evoked sensations would be experienced on the appropriate part of the hand: touch with the bionic index fingertip, for example, would elicit a sensation experienced on the index fingertip. However, the perceived locations of sensations are determined by the idiosyncratic position of the stimulating electrode in the nerve and thus are difficult to predict or control. This problem could be circumvented if perceived sensations shifted over time to become consistent with the position of the sensor that triggers them. We show that, after long-term use of a neuromusculoskeletal prosthesis that featured a mismatch between the sensor location and the resulting tactile experience, the perceived location of the touch did not change.

Recognizing and Correcting MEG Artifacts.

Noise sources in magnetoencephalography (MEG) include: (1) interference from outside the shielded room, (2) other people and devices inside the shielded room, (3) physiologic or nonphysiologic sources inside the patient, (4) activity from inside the head that is unrelated to the signal of interest, (5) intrinsic sensor and recording electronics noise, and (6) artifacts from other apparatus used during recording such as evoked response stimulators. There are other factors which corrupt MEG recording and interpretation and should also be considered "artifacts": (7) inadequate positioning of the patient, (8) changes in the head position during the recording, (9) incorrect co-registration, (10) spurious signals introduced during postprocessing, and (11) errors in fitting. The major means whereby magnetic interference can be reduced or eliminated are by recording inside a magnetically shielded room, using gradiometers that measure differential magnetic fields, real-time active compensation using reference sensors, and postprocessing with advanced spatio-temporal filters. Many of the artifacts that plague MEG are also seen in EEG, so an experienced electroencephalographer will have the advantage of being able to transfer his knowledge about artifacts to MEG. However, many of the procedures and software used during acquisition and analysis may themselves contribute artifact or distortion that must be recognized or prevented. In summary, MEG artifacts are not worse than EEG artifacts, but many are different, and-as with EEG-must be attended to.

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Influences of treadmill speed and incline angle on the kinematics of the normal, osteoarthritic and prosthetic human knee.

The objective of this paper is to measure and to study the influence of the treadmill speed and incline angle on the kinematics of flexion-extension angles of the human knee joints during 23 tests of walking overground and on plane and inclined treadmill performed by a sample of 14 healthy subjects and during of seven tests performed by a sample of five patients suffering of knee osteoarthritis (KOA), before and three months after the total knee replacement (TKR) surgery. The medium cycles computed and plotted for all experimental tests performed by the healthy subjects' sample and for the osteoarthritic (OA) patients' sample before and after TKR surgery are compared and conclusions are formulated.

In vitro performance of six combinations of adjustable differential pressure valves and fixed anti-siphon devices with and without vertical motion.

OBJECTIVE: Adjustable differential pressure (DP) valves in combination with fixed anti-siphon devices are currently a popular combination in counteracting the effects of cerebrospinal fluid overdrainage following implantation of a ventriculoperitoneal shunt system. The study examined the flow performance of three DP valves in successive combination with an anti-siphon device in an in vitro shunt laboratory with and without vertical motion. METHODS: We analyzed three DP valves (Codman Hakim Medos programmable valve [HM], Codman CertasPlus [CP], and Miethke proGAV [PG], in combination with either Codman SiphonGuard [SG] or Miethke ShuntAssistant [SA]), resulting in the evaluation of six different valve combinations. Defined DP conditions between 4 and 40 cm H2O within a simulated shunt system were generated and the specific flow characteristics were measured. In addition, combinations with SA, which is a gravity-dependent valve, were measured in defined spatial positions (90°, 60°). All device combinations were tested during vertical motion with movement frequencies of 2, 3, and 4 Hz. RESULTS: All valve combinations effectively counteracted the siphon effect in relation to the chosen DP. Angulation-related flow changes were similar in the three combinations of DP valve and SA in the 60° and 90° position. In CP-SA and PG-SA, repeated vertical movement at 2, 3, and 4 Hz led to significant increase in flow, whereas in HM-SA, constant increase was seen at 4 Hz only (flow change at 4Hz, DP 40 cm H2O: PG (opening pressure 4 cm H2O) 90°: 0.95 ml/min, 60°: 0.71 ml/min; HM (opening pressure 4 cm H2O) 90°: 0.66 ml/min, 60°: 0.41 ml/min; CP (PL 2) 90°: 0.94 ml/min, 60°: 0.79 ml/min; p < 0.01); however, HM-SA showed relevant motion-induced flow already at low DPs (0.85 ml/min, DP 4 cm H2O). In combinations of DP valve with SG, increase of flow was far less pronounced and even led to significant reduction of flow in certain constellations. Maximum overall flow increase was 0.46 ± 0.04 ml/min with a HM (opening pressure 12 cm H2O) at 2 Hz and a DP of 10 cm H2O, whereas maximum flow decrease was 1.12 ± 0.08 with a PG (opening pressure 4 cm H2O) at 3 Hz and a DP of 10 cmH2O. CONCLUSION: In an experimental setup, all valve combinations effectively counteracted the siphon effect in the vertical position according to their added resistance. Motion-induced increased flow was consistently demonstrated in combinations of DP valve and SA. The combination of HM and SA especially showed relevant motion-induced flow already at low DPs. In combinations of DP and SG, the pattern of the motion induced flow was more inconsistent and motion even led to significant flow reduction, predominantly at DPs of 10 and 20 cmH2O.