Vapor-Phase-Deposited Ag/Ir and Ag/Au Film Heterostructures for Implant Materials: Cytotoxic, Antibacterial and Histological Studies.

Using gas-phase deposition (Physical Vapor Deposition (PVD) and Metal Organic Chemical Vapor Deposition (MOCVD)) methods, modern implant samples (Ti alloy and CFR-PEEK polymer, 30% carbon fiber) were functionalized with film heterostructures consisting of an iridium or gold sublayer, on the surface of which an antibacterial component (silver) was deposited: Ag/Ir(Au)/Ti(CFR-PEEK). The biocidal effect of the heterostructures was investigated, the effect of the surface relief of the carrier and the metal sublayer on antibacterial activity was established, and the dynamics of silver dissolution was evaluated. It has been shown that the activity of Ag/Ir heterostructures was due to high Ag+ release rates, which led to rapid (2-4 h) inhibition of P. aeruginosa growth. In the case of Ag/Au type heterostructures, the inhibition of the growth of P. aeruginosa and S. aureus occurred more slowly (from 6 h), and the antibacterial activity appeared to be due to the contribution of two agents (Ag+ and Au+ ions). It was found, according to the in vitro cytotoxicity study, that heterostructures did not exhibit toxic effects (cell viability > 95-98%). An in vivo biocompatibility assessment based on the results of a morphohistological study showed that after implantation for a period of 30 days, the samples were characterized by the presence of a thin fibrous capsule without volume thickening and signs of inflammation.

Carbon-fibre plates for traumatic and (impending) pathological fracture fixation: Where do we stand? A systematic review.

BACKGROUND: Carbon-fibre (CF) plates are increasingly used for fracture fixation. This systematic review evaluated complications associated with CF plate fixation. It also compared outcomes of patients treated with CF plates versus metal plates, aiming to determine if CF plates offered comparable results. The study hypothesized that CF plates display similar complication rates and clinical outcomes as metal plates for fracture fixation. METHODS: The study adhered to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. The following databases were searched from database inception until June 2023: PubMed, MEDLINE, Embase, Web of Science, Cochrane Library, Emcare, Academic Search Premier and Google Scholar. Studies reporting on clinical and radiological outcomes of patients treated with CF plates for traumatic fractures and (impending) pathological fractures were included. Study quality was assessed, and complications were documented as number and percentage per anatomic region. RESULTS: A total of 27 studies of moderate to very low quality of evidence were included. Of these, 22 studies (800 patients, median follow-up 12 months) focused on traumatic fractures, and 5 studies (102 patients, median follow-up 12 months) on (impending) pathological fractures. A total of 11 studies (497 patients, median follow-up 16 months) compared CF plates with metal plates. Regarding traumatic fractures, the following complications were mostly reported: soft tissue complications (52 out of 391; 13%) for the humerus, structural complications (6 out of 291; 2%) for the distal radius, nonunion and structural complication (1 out of 34; 3%) for the femur, and infection (4 out of 104; 4%) for the ankle. For (impending) pathological fractures, the most frequently reported complications were infections (2 out of 14; 14%) for the humerus and structural complication (6 out of 86; 7%) for the femur/tibia. Comparative studies reported mixed results, although the majority (7 out of 11; 64%) reported no significant differences in clinical or radiological outcomes between patients treated with CF or metal plates. CONCLUSION: This systematic review did not reveal a concerning number of complications related to CF plate fixation. Comparative studies showed no significant differences between CF plates and metal plates for traumatic fracture fixation. Therefore, CF plates appear to be a viable alternative to metal plates. However, high-quality randomized controlled trials (RCTs) with long-term follow-up are strongly recommended to provide additional evidence supporting the use of CF plates. LEVEL OF EVIDENCE: III, systematic review.

Volar PEEK plate for distal radius fracture: analysis of adverse events.

BACKGROUND: The aim of the present retrospective study was to evaluate complications following carbon-fiber-reinforced polyetheretherketon (CFR-PEEK) volar plating in distal radius fracture in a large cohort of patients. As an alternative to conventional metallic devices, CFR-PEEK plates have been introduced over the last few years. METHODS: We performed a retrospective study including all patients who were treated for distal radius fracture using a volar fixed-angle plate DiPHOS-RM (Lima Corporate, Udine, Italy). All CFR-PEEK plates implanted were reviewed between May 2012 and December 2017. Plate removal, second surgery and adverse events were collected by reviewing medical records. A total of 110 patients were included with a mean follow-up of 4 years. RESULTS: Adverse side effects were observed in 9 cases (8%), developed during or after treatment. The most frequent complication was represented by intraoperative plate rupture (4%). Infection was reported in one case. DISCUSSION: The rate of complications of PEEK volar plates seems to be similar to those occurring with plates of different materials. Advantages of PEEK plates are the absence of the cold-welding phenomenon and the absence of exuberant bone callus on the plate, ensuring an easy hardware removal. Intraoperative rupture remains the main complication correlated with PEEK material. These complications can be reduced with an accurate surgical technique, especially at the beginning of the learning curve. LEVEL OF EVIDENCE: Therapeutic IV.

Carbon/PEEK nails: a case-control study of 22 cases.

BACKGROUND: Interest around carbon/PEEK plates and nails has been raising. The elastic modulus close to the bone, the high load-carrying capacity and radiolucency make CFR/PEEK materials a potential breakthrough. In the literature, there are abundant data about CFR/PEEK plates in the treatment of proximal humerus, distal radius and distal fibula fractures. In patients affected by bone metastasis, CFR/PEEK nails were proved effective and safe with 12 months of follow-up. Very little is known about performances of CFR/PEEK nails in patients affected by other pathologies. PURPOSES: The aim of the study was to evaluate safety and efficacy of CFR/PEEK nails in the treatment of various pathological conditions. It was also investigated whatever radiolucency of this nails could lead to a more objective evaluation of bone callus or disease site. PATIENTS AND METHODS: In the study group were included 20 patients (22 bone segments) who underwent CFR/PEEK nail implantation (eight humerus, one tibia, nine femur and four knee arthrodesis). They were affected by pathological fractures, and in four cases, they required an arthrodesis of the knee. They were retrospectively evaluated considering nail failures and bone callus or disease progression (RUSH scores). Mean follow-up time was 11 months (min 6.8-max 20.3). In the control group were included patients treated with titanium nails in the same institution for the same pathologies. An interclass correlation coefficient (ICC) analysis was performed in both groups considering RUSH scores by two expert surgeon from two institution to assess whether radiolucency could lead to a more objective evaluation of disease or bone callus site. RESULTS: The ICC of mean values between RUSH scores was 0.882 (IC 95%: 0.702-0.953) in the CFR/PEEK group, while it was 0.778 (IC 95%: 0.41-0.91) in the titanium group. Observers' evaluation showed a significantly higher obscuration by titanium nails than by CFR/PEEK nails. No osteosynthesis failures were reported in both groups. CONCLUSIONS: Our results confirm the safety of CFR/PEEK nails in the short-medium term. The radiolucency of these materials led our observers to perform more objective evaluations of bone callus formation or disease progression compared to the titanium group given the higher ICC. LEVEL OF EVIDENCE: III Case-control therapeutic study.

Distal radius plate of CFR-PEEK has minimal effect compared to titanium plates on bone parameters in high-resolution peripheral quantitative computed tomography: a pilot study.

BACKGROUND: Carbon-fiber-reinforced poly-ether-ether-ketone (CFR-PEEK) has superior radiolucency compared to other orthopedic implant materials, e.g. titanium or stainless steel, thus allowing metal-artifact-free postoperative monitoring by computed tomography (CT). Recently, high-resolution peripheral quantitative CT (HRpQCT) proved to be a promising technique to monitor the recovery of volumetric bone mineral density (vBMD), micro-architecture and biomechanical parameters in stable conservatively treated distal radius fractures. When using HRpQCT to monitor unstable distal radius fractures that require volar distal radius plating for fixation, radiolucent CFR-PEEK plates may be a better alternative to currently used titanium plates to allow for reliable assessment. In this pilot study, we assessed the effect of a volar distal radius plate made from CFR-PEEK on bone parameters obtained from HRpQCT in comparison to two titanium plates. METHODS: Plates were instrumented in separate cadaveric human fore-arms (n = 3). After instrumentation and after removal of the plates duplicate HRpQCT scans were made of the region covered by the plate. HRpQCT images were visually checked for artifacts. vBMD, micro-architectural and biomechanical parameters were calculated, and compared between the uninstrumented and instrumented radii. RESULTS: No visible image artifacts were observed in the CFR-PEEK plate instrumented radius, and errors in bone parameters ranged from -3.2 to 2.6%. In the radii instrumented with the titanium plates, severe image artifacts were observed and errors in bone parameters ranged between -30.2 and 67.0%. CONCLUSIONS: We recommend using CFR-PEEK plates in longitudinal in vivo studies that monitor the healing process of unstable distal radius fractures treated operatively by plating or bone graft ingrowth.

PEEK and CFR-PEEK as alternative bearing materials to UHMWPE in a fixed bearing total knee replacement: An experimental wear study.

New bearing materials for total joint replacement have been explored as the need to improve longevity and enhance performance is driven by the changing demands of the patient demographic. Carbon-reinforced PEEK has demonstrated good wear characteristics in experimental wear simulation in both simple geometry pin-on-plate studies and in total hip joint replacement. Carbon reinforced PEEK CFR-PEEK has the potential to reduce tibial insert thickness and preserve bone in the knee. This study investigated the wear performance of PEEK and CFR-PEEK in a low conformity total knee replacement configuration. Custom-made flat inserts were tested against cobalt-chromium femoral bearings in a knee wear simulation for a period of three million cycles. Wear was assessed gravimetrically at intervals throughout the study. The wear rates of both PEEK and CFR-PEEK were very high and almost two orders of magnitude higher than the wear rate of UHMWPE under comparable conditions. Evidence of mechanical failure of the materials, including surface cracking and delamination was observed in both materials. This study highlights that these materials may not be suitable alternatives for UHMWPE in low-conformity designs.

Finite Element Analysis of the Stress and Deformation in Bone Caused by CFR-PEEK, Titanium, and Zirconia Ceramic Implants.

Introduction: Glass or carbon fiber-reinforced polyetheretherketone (CFR-PEEK) composites and zirconia ceramic have been offered as more modern implant biomaterials. Objectives: This study examined the effects of zirconia ceramic implants, titanium, and CFR-PEEK on bone stress and deformation. Materials and Methods: A geometric model of a mandibular molar replaced with an implant-supported crown was created for this in vitro finite element analysis investigation. The dimensions of the implant employed in the study are 11.0 mm in length and 4.5 mm in diameter. Using finite element analysis, three implant assemblies composed of zirconium, titanium, and CFR-PEEK were produced. 150 N loads were applied both vertically and obliquely on the long axis of the implant. The von-Mises stresses and deformation were compared using ANSYS Workbench 18.0 and finite element software, with a significance threshold of P < 0.05. Results: All three implant assemblies-zirconia, titanium, and CFR-PEEK-showed comparable stresses and deformation in bone with no appreciable variations. Conclusion: Zirconia and PEEK reinforced with carbon fibers (CFR-PEEK) have been found to be viable replacements for titanium in implant biomaterials.

Investigation of an Optimal Material Addition Rate for Energy Consumption and Dimensional Accuracy in Fused Filament Fabrication of CFR-PEEK.

The material addition rate (MAR) of fused filament fabrication (FFF) is an indicator of process efficiency varied by process parameter settings, which affects energy consumption and part quality in FFF. This study aims to identify the optimal MAR of FFF using carbon-fiber-reinforced polyether-ether-ketone (CFR-PEEK) by considering a trade-off between energy consumption and the dimensional accuracy of FFF outputs. A design of experiments considering two main process parameters is planned to print three sample types through FFF for CFR-PEEK. Then, the MAR (i.e., deposited material volume per build time) of FFF is obtained to derive individual regression models of energy consumption and the dimensional accuracy measured for each sample type. Furthermore, a trade-off between energy consumption and dimensional accuracy on the MAR is formulated to derive an optimal MAR for each sample type. The results show that FFF for CFR-PEEK has a trade-off between energy consumption and dimensional accuracy; there exists a specific MAR that maximizes the overall performance of energy consumption and dimensional accuracy for each sample type. The optimal MAR is the highest for the small volume sample, whereas it becomes the lowest for the vertical build orientation sample. This study suggests that the optimal MAR should be flexibly adjusted based on a fabricated part. The findings from this study also address the fact that decision-making for optimal FFF operations needs a transition from the identification of specific process parameter settings to the management of a proper process efficiency level in FFF.

Inflammatory tissue response in human soft tissue is caused by a higher particle load near carbon fiber-reinforced PEEK compared to titanium plates.

Titanium as the leading implant material in locked plating is challenged by polymers such as carbon fiber-reinforced polyetheretherketone (CFR-PEEK), which became the focus of interest of researchers and manufacturers in recent years. However, data on human tissue response to these new implant materials are rare. Osteosynthesis plates and peri­implant soft tissue samples of 16 healed proximal humerus fractures were examined (n = 8 CFR-PEEK, n = 8 titanium). Soft tissue was analyzed by immunohistochemistry and µCT. The entrapped foreign bodies were further examined for their material composition by FTIR. To gain insight into their origin and formation mechanism, explanted and new plates were evaluated by SEM, EDX, profilometry and HR-CT. In the peri­implant soft tissue of the CFR-PEEK plates, an inflammatory tissue reaction was detected. Tissues contained foreign bodies, which could be identified as tantalum wires, carbon fiber fragments and PEEK particles. Titanium particles were also found in the peri­implant soft tissue of the titanium plates but showed a less intense surrounding tissue inflammation in immunohistochemistry. The surface of explanted CFR-PEEK plates was rougher and showed exposed and broken carbon fibers as well as protruding and deformed tantalum wires, especially in used screw holes, whereas scratches were identified on the titanium plate surfaces. Particles were present in the peri­implant soft tissue neighboring both implant materials and could be clearly assigned to the plate material. Particles from both plate materials caused detectable tissue inflammation, with more inflammatory cells found in soft tissue over CFR-PEEK plates than over titanium plates. STATEMENT OF SIGNIFICANCE: Osteosynthesis plates are ubiquitously used in various medical specialties for the reconstruction of bone fractures and defects and are therefore indispensable for trauma surgeons, ENT specialists and many others. The leading implant material are metals such as titanium, but recently implants made of polymers such as carbon fiber-reinforced polyetheretherketone (CFR-PEEK) have become increasingly popular. However, little is known about human tissue reaction and particle generation related to these new implant types. To clarify this question, 16 osteosynthesis plates (n = 8 titanium and n = 8 CFR-PEEK) and the overlying soft tissue were analyzed regarding particle occurrence and tissue inflammation. Tissue inflammation is clinically relevant for the development of scar tissue, which is discussed to cause movement restrictions and thus contributes significantly to patient outcome.

AB081. Experience using CFR-PEEK implants in metastatic and primary spine tumour surgery: a single centre retrospective study.

BACKGROUND: Titanium has been the conventional implant material of choice for fixation in both primary and metastatic spine tumour surgeries (MSTS). However, these implants result in artefact generation during post-operative computed tomography (CT) or magnetic resonance imaging (MRI), resulting in poor planning of radiotherapy (RT) and suboptimal tumour surveillance. Carbon fibre-reinforced polyetheretherketone (CFR-PEEK) implants have gained momentum for instrumentation in MSTS due to their radiolucent properties. This in turn does not sacrifice the biomechanical strength of the implants. In this study, we compared the peri-operative outcomes, post operative imaging artefacts and dosimetricdata of CFR-PEEK implants to titanium implants to asses for potential benefits in post-operative RT planning in patients who underwent MSTS. METHODS: This is a retrospective study involving 42 patients operated for MSTS. Patient-related data including demographics, tumour pathology, intra-operative data, functional outcome, and RT-related data were collected for both groups. All patients were followed-up post-operatively for a minimum of 2 years or until demise, whichever was earlier. RESULTS: In our study, 20 (47.6%) patients had CFR-PEEK implants, while 22 (52.4%) of patients had titanium implants used for MSTS. Both groups of patients had similar clinical outcomes for pain and overall survival predictability pre-operatively (P>0.05). Mean number of levels instrumented by titanium screws were 6.8±2.93, while for the CFR-PEEK screws were 4.07±1.05. Mean volume of artefact generated during post operative CT was 75.1±43.4 mm3 in titanium group and 13.3±14.2 mm3 in CFR-PEEK group (P=0.005). The mean time taken to contour the artefacts was 17.3±5.84 minutes in the titanium group, while the CFR-PEEK group took 9.60±7.17 minutes (P=0.049). CONCLUSIONS: Our study suggests that carbon fibre reinforced PEEK screws significantly reduce artefact generation and the time taken to contour them during post-operative RT planning, while delivering equivalent clinical and functional outcomes as compared to standard titanium implants.

Micro-CT analysis and mechanical properties of low dimensional CFR-PEEK specimens additively manufactured by material extrusion.

Material extrusion of thermoplastic polymers enables the realization of complex specific designs with high performance composites. The present study aims at evaluating the mechanical properties of carbon fiber-reinforced semi-crystalline thermoplastic polymer polyether ether ketone (CFR-PEEK) manufactured by material extrusion and correlating them with results obtained by micro-CT. Samples in the shape of small bars were provided by Kumovis (Munich, Germany). The determination of surface roughness and density was followed by three-point bending tests. To reveal the pore distribution as well as the fusion quality of CFR PEEK when applied with external forces, micro-CT scans were performed with an X-ray microscope before and after the mechanical test to localize the sites where the fracture is generated. The density of CFR-PEEK bars indicated that they had superior mechanical properties compared with our previous study on unfilled 3D printed PEEK (bending modulus: (5.4 ± 0.5) GPa vs. (1.05 ± 0.05) GPa to (1.48 ± 0.10) GPa; bending strength: (167 ± 11) MPa vs. (51 ± 15) to (193 ± 7) MPa). Micro-CT analyses revealed the local 3D-distribution of voids. Voids of 30 µm diameter are nearly spherical and make up the main part of the total porosity. The larger the voids, the more they deviate from a spherical shape. Significant lack-of-fusion voids are located between the deposited filaments. By growing and merging, they act as seeds for the forming fracture line in the region of the flexural specimens where the maximum local tensile stresses occurred under bending load. Our work provides a detailed analysis of printed PEEK with fiber additive and relates this with mechanical properties.

Evaluation of stress and deformation in bone with titanium, CFR-PEEK and zirconia ceramic implants by finite element analysis.

Background: As more recent implant biomaterials, Zirconia ceramic and glass or carbon fibre reinforced PEEK composites have been introduced. In this study, bone stress and deformation caused by titanium, carbon fiber-reinforced polyetheretherketone (CFRPEEK), and zirconia ceramic implants were compared. Materials and Methods: In this in vitro finite element analysis study, a geometric model of mandibular molar replaced with implant supported crown was generated. The study used an implant that was 5 mm diameter and 11.5 length. Three implant assemblies made of CFR- polyetheretherketone (PEEK), zirconium, and titanium were created using finite element analysis (FEM). On the implant's long axis, 150 N loads were applied both vertically and obliquely. ANSYS Workbench 18.0 and finite element software were used to compare the Von Mises stresses and deformation produced with a significance level of P < 0.05. Results: With no discernible differences, all three implant assemblies that is CFR-PEEK, titanium, and zirconia demonstrated similar stresses and deformation in bone. Conclusion: It was determined that zirconia and PEEK and reinforced with carban fibres (CFR-PEEK) can be used as titanium-free implant biomaterial substitutes.

Effect of sulfonation time on physicochemical, osteogenic, antibacterial properties and biocompatibility of carbon fiber reinforced polyether ether ketone.

The carbon fiber reinforced polyetheretherketone (CFR-PEEK) has been increasingly used in orthopedics dentistry due to its excellent biocompatibility and mechanical properties. However, the biological inertness and poor antibacterial activity limit its clinical applications. This paper focused on the performances of CFR-PEEK with porous morphology that were exposed to different sulfonation periods (1, 3, 5, and 10 min, corresponding to CP-S1, CP-S3, CP-S5, and CP-S10, respectively). Residual sulfuric acid was removed by acetone rinsing, NaOH immersion, and hydrothermal treatment before in vitro and in vivo studies. The results showed some significant difference in the physicochemical properties, including energy dispersive X-ray spectroscopy (EDS) map of sulfur atoms, X-ray photoelectron spectroscopy (XPS) of valences of sulfur ions, Fourier transformation infrared spectroscopy (FTIR), hydrophilicity, hardness, and elastic modulus among CP-S3, CP-S5, and CP-S10. However, CP-S5 and CP-S10 were more effective in promoting the proliferation, adhesion, and osteogenic differentiation of seeded bone mesenchymal stem cells (BMSCs) and growth inhibition of S. aureus and P. gingivalis compared with other groups. Furthermore, the CP-S5 and CP-S10 samples achieved better cranial bone repair than the non-sulfonation group in a rat model. Therefore, it can be inferred that both 5 and 10 min are viable sulfonation durations for 30% CFR-PEEK. These findings provide a theoretical basis for developing CFR-PEEK for clinical applications.

An overview of the tribological and mechanical properties of PEEK and CFR-PEEK for use in total joint replacements.

Poly-ether-ether-ketone (PEEK) and PEEK composites are outstanding candidates for biomedical applications, such as orthopedic devices, where biocompatibility and modulus match with surrounding tissue are requisite for long-term success. The mechanical properties can be optimized by incorporating fillers such as continuous and chopped carbon fibers. While much is known about the mechanical and tribological behavior of PEEK composites, there are few articles that summarize the viability of using PEEK reinforced with carbon fibers in orthopedic implants. This paper reviews biocompatibility, tribological, and mechanical studies on PEEK and their composites with carbon fibers, notably PEEK reinforced with polyacrylonitrile (PAN)-based carbon fibers and PEEK reinforced with pitch-based carbon fibers, for application in orthopedics and total joint replacements (TJRs). The main objectives of this review are two-fold. Firstly, this paper aims to assist designers in making informed decisions on the suitability of using PEEK and PEEK composites in orthopedic applications; as it is not well understood how these materials perform on the whole in orthopedics and TJRs. Secondly, this paper aims to serve as a centralized paper in which researchers can gain information on the tribological and mechanical advancements of PEEK and PEEK composites.

Cross-link augmentation enhances CFR-PEEK short fixation in lumbar metastasis stabilization.

Introduction: Spinal stability plays a crucial role in the success of the surgical treatment of lumbar vertebral metastasis and, in current practice, less invasive approaches such as short constructs have been considered. Concurrently, carbon fiber-reinforced (CFR) poly-ether-ether-ketone (PEEK) fixation devices are expanding in oncologic spinal surgery thanks to their radiotransparency and valid mechanical properties. This study attempts to provide an exhaustive biomechanical comparison of different CFR-PEEK surgical stabilizations through a highly reproducible experimental setup. Methods: A Sawbones biomimetic phantom (T12-S1) was tested in flexion, extension, lateral bending, and axial rotation. An hemisome lesion on L3 vertebral body was mimicked and different pedicle screw posterior fixations were realized with implants from CarboFix Orthopedics Ltd: a long construct involving two spinal levels above and below the lesion, and a short construct involving only the levels adjacent to L3, with and without the addition of a transverse rod-rod cross-link; to provide additional insights on its long-term applicability, the event of a pedicle screw loosening was also accounted. Results: Short construct reduced the overloading onset caused by long stabilization. Particularly, the segmental motion contribution less deviated from the physiologic pattern and also the long-chain stiffness was reduced with respect to the prevalent long construct. The use of the cross-link enhanced the short stabilization by making it significantly stiffer in lateral bending and axial rotation, and by limiting mobiliza-tion in case of pedicle screw loosening. Discussion: The present study proved in vitro the biomechanical benefits of cross-link augmentation in short CFR-PEEK fixation, demonstrating it to be a potential alternative to standard long fixation in the surgical management of lumbar metastasis.

Investigation of the biomechanical stability of Cfr-PEEK in the treatment of mandibular angulus fractures by finite element analysis.

The purpose of this study is to explore the effectiveness of Cfr-PEEK, in the fixation of unfavorable fractures of mandibular angulus by comparing it with the titanium and resorbable biomaterials. 8 different fixation models were created. In the first 4 groups, a single mini plate was applied to the upper edge of the fracture line by the Champy method. In the other 4 groups, an additional plate was placed on the lower edge of the fracture line. In these models, titanium, resorbable and Cfr-PEEK plate/screw systems were investigated by the finite element analysis method. The highest Von Mises stress was observed on the upper plate in the group 5 while the lowest was seen in the lower plate in the group 7. The highest stress values on the screws were observed on the screws placed closer to the fracture line. Considering the stresses on the bone around the screws, the highest Pmax and Pmin values were seen in group 5, and the lowest values were seen in the group 7. The highest displacement was observed in the group 3, while the lowest was observed in the group 5. According to the results it can be said that Cfr-PEEK plate/screw systems may provide advantages by decreasing the stresses on the fixation systems over the titanium plates and providing more stable fixation over the resorbable systems. Cfr-PEEK plates of 2 mm thickness seems to be a potential alternative to 1 mm thick titanium plates.

Comprehensive Evaluation of Carbon-Fiber-Reinforced Polyetheretherketone (CFR-PEEK) Spinal Hardware for Proton and Photon Planning.

Purpose: To evaluate a novel spine implant, carbon-fiber-reinforced polyetheretherketone (CFR-PEEK), for proton and photon treatment planning. Materials and Methods: We compared target coverage and sparing of organs-at-risk (OARs) for a spinal phantom with 4 different spine configurations: (a) normal (no implant); (b) Titanium; (c) CFR-PEEK; and (d) hybrid (CFR-PEEK with Titanium tulip head). The spinal phantom was imaged via computed tomography (CT) scan, and the iterative Metal Artifact Reduction (iMAR) CT set was used for planning. A representative spinal chordoma target and associated OARs were contoured. The prescription dose was 50 Gy to the initial target volume, followed by a 24 Gy boost, for which multi-field optimization (MFO) proton plans were developed with a 3 mm setup and 3.5% range uncertainties. For photon planning, volumetric modulated arc therapy (VMAT) plans were developed for the initial and boost plans. OAR dose constraints were set according to our institutional guidelines. Results: For the 4 spine configurations, the proton plans achieved similar nominal target coverage and OARs sparing. While evaluating coverage and OAR dose under uncertainty scenario analysis for initial clinical target volume (CTV) 50 Gy 95% and 90% coverage, higher means and the narrower band of doses variations were achieved for the normal and CFR-PEEK plans. Similarly, uncertainty analysis of spinal cord Dmax showed tighter distribution for normal and CFR-PEEK plans. Overall plan quality showed no significant difference for photon planning when compared to normal spine versus other inserts. However, for proton planning, there is a larger difference for the normal spine insert scenario versus the Titanium insert scenario. For each insert scenario comparison between photon and proton plans, there was a larger difference for OARs: heart and spinal cord. Conclusion: The CFR-PEEK implant has similar clinical properties to a normal spine for proton planning, allowing us to pass protons through the material and achieve superior target coverage and OAR sparing under nominal and uncertainty conditions.

Laser Direct-Write Sensors on Carbon-Fiber-Reinforced Poly-Ether-Ether-Ketone for Smart Orthopedic Implants.

Mechanically close-to-bone carbon-fiber-reinforced poly-ether-ether-ketone (CFR-PEEK)-based orthopedic implants are rising to compete with metal implants, due to their X-ray transparency, superior biocompatibility, and body-environment stability. While real-time strain assessment of implants is crucial for the postsurgery study of fracture union and failure of prostheses, integrating precise and durable sensors on orthopedic implants remains a great challenge. Herein, a laser direct-write technique is presented to pattern conductive features (minimum sheet resistance <1.7 Ω sq-1 ) on CRF-PEEK-based parts, which can act as strain sensors. The as-fabricated sensors exhibit excellent linearity (R2  = 0.997) over the working range (0-2.5% strain). While rigid silicon- or metal-based sensor chips have to be packaged onto flat surfaces, all-carbon-based sensors can be written on the complex curved surfaces of CFR-PEEK joints using a portable laser mounted on a six-axis robotic manipulator. A wireless transmission prototype is also demonstrated using a Bluetooth module. Such results will allow a wider space to design sensors (and arrays) for detailed loading progressing monitoring and personalized diagnostic applications.

CFR-PEEK Pedicle Screw Instrumentation for Spinal Neoplasms: A Single Center Experience on Safety and Efficacy.

(1) Background: Surgery for spinal metastases has gained a decisive role in modern oncological treatment. Recently, carbon-fiber-reinforced (CFR) polyethyl-ether-ether-ketone (PEEK) pedicle screw systems were introduced, reducing artifacts on imaging and showing less perturbation effects on photon radiation. Preliminary clinical experience with CFR-PEEK implants for spinal metastases exists. The aim of this monocentric study is to report on the safety and efficacy of CFR-PEEK pedicle screw systems for spinal neoplasms in a large cohort of consecutive patients. (2) Methods: We retrospectively analyzed prospectively the collected data of consecutive patients being operated on from 1 August 2015 to 31 October 2021 using a CFR-PEEK pedicle screw system for posterior stabilization because of spinal metastases or primary bone tumors of the spine. (3) Results: We included 321 patients of a mean age of 65 ± 13 years. On average, 5 ± 2 levels were instrumented. Anterior reconstruction was performed in 121 (37.7%) patients. Intraoperative complications were documented in 30 (9.3%) patients. Revision surgery for postoperative complications was necessary in 55 (17.1%) patients. Implant-related complications, such as intraoperative screw breakage (3.4%) and screw loosening (2.2%), were rare. (4) Conclusions: CFR-PEEK is a safe and efficient alternative to titanium for oncological spinal instrumentation, with low complication and revision rates in routine use and with the advantage of its radiolucency.

Long Term Results of a Rotating Hinge Total Knee Prosthesis With Carbon-Fiber Reinforced Poly-Ether-Ether-Ketone (CFR-PEEK) as Bearing Material.

Background: The use of rotating hinge (RH) prostheses for severe primary as well as revision arthroplasty is widely established. Due to the steadily increasing number of RH prostheses, we aimed to assess the complication frequencies, complication types and clinical outcomes of a modern RH hinge prosthesis using a new bearing material with a minimum follow-up of 7 years. Methods: Fifty-six consecutive patients who received the EnduRo® RH prosthesis using carbon-fiber reinforced poly-ether-ether-ketone (CFR-PEEK) as bearing material were included in this prospective study: 21 patients (37.5%) received the prosthesis as a primary total knee arthroplasty (TKA) and 35 patients (62.5%) underwent revision total knee arthroplasties (rTKA). Clinical and radiographic examinations were performed preoperatively, postoperatively after three and 12 months and annually thereafter. Clinical scores were documented for each patient. Competing risk analysis was assessed with respect to indication and failure mode. Results: Knee Society Score (KSS), Western Ontario and McMaster Osteoarthritis Index (WOMAC), Oxford Knee Score (OKS) and range of motion (ROM) improved significantly compared to preoperative values (p < 0.0001). The overall cumulative incidence for revision surgery was 23.6% at 7 years and the cumulative incidence for complications associated with failure of the prothesis was 5.6% at 7 years, respectively. Complications occurred more frequently in the revision group (p = 0.002). Conclusion: The evaluated RH prosthesis provided reliable and durable results for a minimum follow-up of 7 years. Prosthesis survival was successful considering the complexity of the cases. The use of this RH system in primary patients showed high survival rates and long-term functional outcomes and clinical outcomes proved to be satisfying in both revision and primary cases. No adverse events were associated with the new bearing material CFR-PEEK.