Implant Strength Contributes to the Osseointegration Strength of Porous Metallic Materials.

Creating the optimal environment for effective and long term osseointegration is a heavily researched and sought-after design criteria for orthopedic implants. A validated multimaterial finite element (FE) model was developed to replicate and understand the results of an experimental in vivo push-out osseointegration model. The FE model results closely predicted global force (at 0.5 mm) and stiffness for the 50-90% porous implants with an r2 of 0.97 and 0.98, respectively. In addition, the FE global force at 0.5 mm showed a correlation to the maximum experimental forces with an r2 of 0.90. The highest porosity implants (80-90%) showed lower stiffnesses and more equitable load sharing but also failed at lower a global force level than the low porosity implants (50-70%). The lower strength of the high porosity implants caused premature plastic deformation of the implant itself during loading as well as significant deformations in the ingrown and surrounding bone, resulting in lower overall osseointegration strength, consistent with experimental measurements. The lower porosity implants showed a balance of sufficient bony ingrowth to support osseointegration strength coupled with implant mechanical properties to circumvent significant implant plasticity and collapse under the loading conditions. Together, the experimental and finite element modeling results support an optimal porosity in the range of 60-70% for maximizing osseointegration with current structure and loading.

Lateral fenestration of lumbar intervertebral discs in rabbits: development and characterisation of an in vivo preclinical model with multi-modal endpoint analysis.

PURPOSE: To evaluate the biological and biomechanical effects of fenestration/microdiscectomy in an in vivo rabbit model, and in doing so, create a preclinical animal model of IVDD. METHODS: Lateral lumbar IVD fenestration was performed in vivo as single- (L3/4; n = 12) and multi-level (L2/3, L3/4, L4/5; n = 12) fenestration in skeletally mature 6-month-old New Zealand White rabbits. Radiographic, micro-CT, micro-MRI, non-destructive robotic range of motion, and histological evaluations were performed 6- and 12-weeks postoperatively. Independent t tests, one-way and two-way ANOVA and Kruskal-Wallis tests were used for parametric and nonparametric data, respectively. Statistical significance was set at P < 0.05. RESULTS: All rabbits recovered uneventfully from surgery and ambulated normally. Radiographs and micro-CT demonstrated marked reactive proliferative osseous changes and endplate sclerosis at fenestrated IVDs. Range of motion at the fenestrated disc space was significantly reduced compared to intact controls at 6- and 12-weeks postoperatively (P < 0.05). Mean disc height index percentage for fenestrated IVDs was significantly lower than adjacent, non-operated IVDs for both single and multi-level groups, at 6 and 12 weeks (P < 0.001). Pfirrmann MRI IVDD and histological grading scores were significantly higher for fenestrated IVDs compared to non-operated adjacent and age-matched control IVDs for single and multi-level groups at 6 and 12 weeks (P < 0.001). CONCLUSIONS: Fenestration, akin to microdiscectomy, demonstrated significant biological, and biomechanical effects in this in vivo rabbit model and warrants consideration by veterinary and human spine surgeons. This described model may be suitable for preclinical in vivo evaluation of therapeutic strategies for IVDD in veterinary and human patients.

Anterior cruciate ligament zoobiquity: Can man's best friend tell us we are being too cautious with the implementation of osteotomy to correct posterior tibial slope.

Anterior cruciate ligament (ACL) reconstruction (ACLR) is used to treat clinical instability post ACL rupture, however, there is a high rate of incomplete return to sport and rerupture. There is increasing interest in posterior tibial slope as an intrinsic risk factor for ACLR failure and persistent instability. Zoobiquity describes the collaboration between the human and veterinary professions in order to advance the scientific understanding of both fields. Given the cranial cruciate ligament (CCL) in dogs is synonymous with the anterior cruciate ligament in humans, functioning to control internal rotation and anterior translation, but osteotomies, rather than ligament reconstruction, are the mainstay of treatment for CCL rupture, this editorial sort to gain insights into this form of treatment from the veterinary world. Level of Evidence: Level V, evidence.

Antimicrobial Peptidomimetics Prevent the Development of Resistance against Gentamicin and Ciprofloxacin in Staphylococcus and Pseudomonas Bacteria.

Bacteria readily acquire resistance to traditional antibiotics, resulting in pan-resistant strains with no available treatment. Antimicrobial resistance is a global challenge and without the development of effective antimicrobials, the foundation of modern medicine is at risk. Combination therapies such as antibiotic-antibiotic and antibiotic-adjuvant combinations are strategies used to combat antibiotic resistance. Current research focuses on antimicrobial peptidomimetics as adjuvant compounds, due to their promising activity against antibiotic-resistant bacteria. Here, for the first time we demonstrate that antibiotic-peptidomimetic combinations mitigate the development of antibiotic resistance in Staphylococcus aureus and Pseudomonas aeruginosa. When ciprofloxacin and gentamicin were passaged individually at sub-inhibitory concentrations for 10 days, the minimum inhibitory concentrations (MICs) increased up to 32-fold and 128-fold for S. aureus and P. aeruginosa, respectively. In contrast, when antibiotics were passaged in combination with peptidomimetics (Melimine, Mel4, RK758), the MICs of both antibiotics and peptidomimetics remained constant, indicating these combinations were able to mitigate the development of antibiotic-resistance. Furthermore, antibiotic-peptidomimetic combinations demonstrated synergistic activity against both Gram-positive and Gram-negative bacteria, reducing the concentration needed for bactericidal activity. This has significant potential clinical applications-including preventing the spread of antibiotic-resistant strains in hospitals and communities, reviving ineffective antibiotics, and lowering the toxicity of antimicrobial chemotherapy.

Bioinspired Polydopamine Coatings Facilitate Attachment of Antimicrobial Peptidomimetics with Broad-Spectrum Antibacterial Activity.

The prevention and treatment of biofilm-mediated infections remains an unmet clinical need for medical devices. With the increasing prevalence of antibiotic-resistant infections, it is important that novel approaches are developed to prevent biofilms forming on implantable medical devices. This study presents a versatile and simple polydopamine surface coating technique for medical devices, using a new class of antibiotics-antimicrobial peptidomimetics. Their unique mechanism of action primes them for activity against antibiotic-resistant bacteria and makes them suitable for covalent attachment to medical devices. This study assesses the anti-biofilm activity of peptidomimetics, characterises the surface chemistry of peptidomimetic coatings, quantifies the antibacterial activity of coated surfaces and assesses the biocompatibility of these coated materials. X-ray photoelectron spectroscopy and water contact angle measurements were used to confirm the chemical modification of coated surfaces. The antibacterial activity of surfaces was quantified for S. aureus, E. coli and P. aeruginosa, with all peptidomimetic coatings showing the complete eradication of S. aureus on surfaces and variable activity for Gram-negative bacteria. Scanning electron microscopy confirmed the membrane disruption mechanism of peptidomimetic coatings against E. coli. Furthermore, peptidomimetic surfaces did not lyse red blood cells, which suggests these surfaces may be biocompatible with biological fluids such as blood. Overall, this study provides a simple and effective antibacterial coating strategy that can be applied to biomaterials to reduce biofilm-mediated infections.

Sagittal patellar flexion angle measurement determines greater incidence of patella alta in patellar tendinopathy patients.

PURPOSE: The objective of this study was to compare patellar height and patella alta between a control cohort and patients with patellar tendinopathy by the sagittal patellar flexion angle (SPFA) measurement. METHODS: Magnetic resonance imaging (MRI) scans of the knee were obtained from a sports imaging facility and screened to select patients with anterior knee pain. This symptomatic group was divided into two patient cohorts: those with and without MRI features of patellar tendinopathy. Lateral knee radiographs were reviewed and SPFA, knee flexion angle and Insall-Salvati ratio (IS) were measured from the radiographs by two independent reviewers. RESULTS: A total of 99 patients consisting of 48 patellar tendinopathy patients and 51 control patients were included. There was a significantly higher mean patellar height (p = 0.002, d = 0.639) and a greater patella alta incidence in the patellar tendinopathy cohort (25.0%) compared to the controls (3.9%) (p = 0.022, d = 0.312). Insall-Salvati ratio measurements showed no difference in patella alta incidence between tendinopathy and control cohorts. There was excellent inter- and intra-observer reliability of SPFA measurements (ICC 0.99). CONCLUSION: This is the first study to demonstrate a greater incidence of patella alta in patellar tendinopathy patients compared to controls. A greater patella alta incidence amongst patellar tendinopathy patients as defined by SPFA was found to be clinically relevant, as it suggests these patients may comprise the recalcitrant patient subgroup who do not improve with current surgical intervention and may therefore benefit from a biomechanical surgical solution. LEVEL OF EVIDENCE: III.

The Reliability of the Microsoft Kinect and Ambulatory Sensor-Based Motion Tracking Devices to Measure Shoulder Range-of-Motion: A Systematic Review and Meta-Analysis.

Advancements in motion sensing technology can potentially allow clinicians to make more accurate range-of-motion (ROM) measurements and informed decisions regarding patient management. The aim of this study was to systematically review and appraise the literature on the reliability of the Kinect, inertial sensors, smartphone applications and digital inclinometers/goniometers to measure shoulder ROM. Eleven databases were screened (MEDLINE, EMBASE, EMCARE, CINAHL, SPORTSDiscus, Compendex, IEEE Xplore, Web of Science, Proquest Science and Technology, Scopus, and PubMed). The methodological quality of the studies was assessed using the consensus-based standards for the selection of health Measurement Instruments (COSMIN) checklist. Reliability assessment used intra-class correlation coefficients (ICCs) and the criteria from Swinkels et al. (2005). Thirty-two studies were included. A total of 24 studies scored "adequate" and 2 scored "very good" for the reliability standards. Only one study scored "very good" and just over half of the studies (18/32) scored "adequate" for the measurement error standards. Good intra-rater reliability (ICC > 0.85) and inter-rater reliability (ICC > 0.80) was demonstrated with the Kinect, smartphone applications and digital inclinometers. Overall, the Kinect and ambulatory sensor-based human motion tracking devices demonstrate moderate-good levels of intra- and inter-rater reliability to measure shoulder ROM. Future reliability studies should focus on improving study design with larger sample sizes and recommended time intervals between repeated measurements.

Correction to: 3D-printed spine surgery implants: a systematic review of the efficacy and clinical safety profile of patient-specific and off-the-shelf devices.

Unfortunately, 3rd author's first name was incorrectly published in the original publication. The complete correct name is given below.

3D-printed spine surgery implants: a systematic review of the efficacy and clinical safety profile of patient-specific and off-the-shelf devices.

PURPOSE: Three-dimensional printing (3DP), or additive manufacturing, is an emergent fabrication technology for surgical devices. As a production method, 3DP enables physical realisation of surgical implants from geometrically complex digital-models in computer-aided design. Spine surgery has been an innovative adopter of 3DP technology for both patient-specific (PS) and market-available 'Off-The-Shelf' (OTS) implants. The present study assessed clinical evidence for efficacy and safety of both PS and OTS 3DP spinal implants through review of the published literature. The aim was to evaluate the clinical utility of 3DP devices for spinal surgery. METHODS: A systematic literature review of peer-reviewed papers featured on online medical databases evidencing the application of 3DP (PS and OTS) surgical spine implants was conducted in accordance with PRISMA guidelines. RESULTS: Twenty-two peer-reviewed articles and one book-chapter were eligible for systematic review. The published literature was limited to case reports and case series, with a predominant focus on PS designs fabricated from titanium alloys for surgical reconstruction in cases where neoplasia, infection, trauma or degenerative processes of the spine have precipitated significant anatomical complexity. CONCLUSION: PS and 3DP OTS surgical implants have demonstrated considerable utility for the surgical management of complex spine pathology. The reviewed literature indicated that 3DP spinal implants have also been used safely, with positive surgeon- and patient-reported outcomes. However, these conclusions are tentative as the follow-up periods are still relatively short and the number of high-powered studies was limited. Single case and small case series reporting would benefit greatly from more standardised reporting of clinical, radiographic and biomechanical outcomes. These slides can be retrieved under Electronic Supplementary Material.

Comparative osteoconductivity of bone void fillers with antibiotics in a critical size bone defect model.

The study aimed to evaluate the comparative osteoconductivity of three commercially available bone void fillers containing gentamicin with respect to new bone, growth, host tissue response and resorption of the implant material. Defects were created in the cancellous bone of the distal femur and proximal tibia of 12-skeletally mature sheep and filled with three commercially available bone void fillers containing gentamicin (Stimulan-G, Cerament-G, Herafill-G). Peripheral blood was taken pre-operatively and at the time of implantation, as well as at intermittent timepoints following surgery to determine systemic gentamicin levels (5-,15- and 30- minutes, 1, 2, 3, 6, 12, 24, 48- and 72-hours, 3-, 6- and 12-weeks). Decalcified, embedded samples were stained with haematoxylin and eosin (H&E) and used to assess the host tissue response and the formation of new bone in the presence of test implant materials. No adverse reactions were noted at harvest at any time points for any cancellous implantation sites with the various implant materials. Comparative microCT analysis of the Stimulan-G, Cerament-G and Herafill-G test materials revealed a similar increase in bone surface area and volume between animals implanted with Stimulan-G or Cerament-G test materials. Animals implanted with Herafill-G test materials demonstrated the lowest increases in bone volume and surface area of the test materials tested, at levels similar to the negative control sites. By 12-weeks, Stimulan-G defects were completely closed with mature bone and bone marrow whilst the Cerament-G material was still present after 12 weeks by histological examination. In conclusion, this study demonstrated differences in the bone regenerative capacity of a range of bone void fillers in an in vivo setting.

Sagittal patellar flexion angle: a novel clinically validated patellar height measurement reflecting patellofemoral kinematics useful throughout knee flexion.

PURPOSE: Patellar height measurements on lateral radiographs are dependent on knee flexion which makes standardisation of measurements difficult. This study described a plain radiographic measurement of patellar sagittal height which reflects patellofemoral joint kinematics and can be used at all degrees of flexion. METHODS: The study had two parts. Part one involved 44 normal subjects to define equations for expected patellar position based on the knee flexion angles for three new patellar height measurements. A mixed model regression with random effect for individual was used to define linear and polynomial equations for expected patellar position relating to three novel measurements of patella height: (1) patellar progression angle (trochlea), (2) patellar progression angle (condyle) and (3) sagittal patellar flexion. Part two was retrospective and involved applying these measurements to a surgical cohort to identify differences between expected and measured patellar position pre- and post-operatively. RESULTS: All three measurements provided insight into patellofemoral kinematics. Sagittal patellar flexion was the most useful with the least residual error, was the most reliable, and demonstrated the greatest detection clinically. CONCLUSIONS: Clinically applied radiographic measurements have been described for patellar height which reflect the sagittal motion of the patella and can be used regardless of the degree of flexion in which the radiograph was taken. The expected sagittal patellar flexion linear equation should be used to calculate expected patellar height. LEVEL OF EVIDENCE: IV.

Effects of SCCO2, Gamma Irradiation, and Sodium Dodecyl Sulfate Treatments on the Initial Properties of Tendon Allografts.

Sterile and decellularized allograft tendons are viable biomaterials used in reconstructive surgeries for dense connective tissue injuries. Established allograft processing techniques including gamma irradiation and sodium dodecyl sulfate (SDS) can affect tissue integrity. Supercritical carbon dioxide (SCCO2) represents a novel alternative that has the potential to decellularize and sterilize tendons with minimized exposure to denaturants, shortened treatment time, lack of toxic residues, and superior tissue penetration, and thus efficacy. This study attempted to develop a single-step hybrid decellularization and sterilization protocol for tendons that involved SCCO2 treatment with various chemical additives. The processed tendons were evaluated with mechanical testing, histology, scanning electron microscopy (SEM), and Fourier-transform infrared (FTIR) spectroscopy. Uniaxial mechanical testing showed that tendons treated with SCCO2 and additive NovaKillTM Gen2 and 0.1% SDS had significantly higher (p < 0.05) ultimate tensile stress (UTS) and Young's modulus compared to gamma-irradiated and standard-SDS-treated tendons. This was corroborated by the ultrastructural intactness of SCCO2-treated tendons as examined by SEM and FTIR spectroscopy, which was not preserved in gamma-irradiated and standard SDS-treated tendons. However, complete decellularization was not achieved by the experimented SCCO2-SDS protocols used in this study. The present study therefore serves as a concrete starting point for development of an SCCO2-based combined sterilization and decellularization protocol for allograft tendons, where additive choice is to be optimized.

A New Era of Antibiotics: The Clinical Potential of Antimicrobial Peptides.

Antimicrobial resistance is a multifaceted crisis, imposing a serious threat to global health. The traditional antibiotic pipeline has been exhausted, prompting research into alternate antimicrobial strategies. Inspired by nature, antimicrobial peptides are rapidly gaining attention for their clinical potential as they present distinct advantages over traditional antibiotics. Antimicrobial peptides are found in all forms of life and demonstrate a pivotal role in the innate immune system. Many antimicrobial peptides are evolutionarily conserved, with limited propensity for resistance. Additionally, chemical modifications to the peptide backbone can be used to improve biological activity and stability and reduce toxicity. This review details the therapeutic potential of peptide-based antimicrobials, as well as the challenges needed to overcome in order for clinical translation. We explore the proposed mechanisms of activity, design of synthetic biomimics, and how this novel class of antimicrobial compound may address the need for effective antibiotics. Finally, we discuss commercially available peptide-based antimicrobials and antimicrobial peptides in clinical trials.

Effects of supercritical fluid CO2 and 25 kGy gamma irradiation on the initial mechanical properties and histological appearance of tendon allograft.

Tendon allografts, when autograft options are limited or when obtaining an autograft is not aligned with the patients' best interest, play an important role in tendon and ligament reconstruction. To minimize the risk of infectious disease transmission tissue banks perform screening tests and the allografts cleaned are sterilized. The current study examines and compares the initial mechanical properties and histological appearance of supercritical CO2 (SCCO2)-treated and gamma-irradiated porcine extensor tendons. Thirty intact porcine forelimb extensor tendons randomized equally into three groups: control group, gamma-irradiation group, and SCCO2-treated group. Once treated, histological assessment and histomorphologic measurements were made on the histological sections obtained from each tendon while stiffness and ultimate failure loads were evaluated from tensile testing. Histological evaluation of gamma-irradiated tendons showed significant disruption to the hierarchical morphology of the fascicle bundles, which was not evident in SCCO2-treated specimens. Histomorphologic measurements showed a significant increase for measured dead space (void) between tendon fibrils of the gamma-irradiated group comparing to both control and SCCO2 treated groups (p < 0.01). There was a significant reduction in the ultimate failure load for tendons treated by gamma-irradiation compared to the control group (p < 0.05). No statistically significant difference was detected between control and SCCO2-treated tendons in the ultimate failure load. Stiffness values were not significantly different between three-study groups. This study suggests that while gamma-irradiation has a deleterious effect on mechanical properties of tendon tissue, SCCO2 does not alter the biomechanical properties and the histological structure of porcine extensor tendons.

Three-dimensional kinematics of the canine carpal bones imaged with computed tomography after ex vivo axial limb loading and palmar ligament transection.

OBJECTIVE: To describe normal antebrachiocarpal joint kinematic motion during axial loading and to describe the effect of palmar radiocarpal ligament (PRL) and palmar ulnocarpal ligament (PUL) transection on this motion. SAMPLE POPULATION: Ten forelimbs from 5 adult greyhound cadavers. METHODS: Limbs were placed in a custom jig and computed tomography images of limbs were obtained in neutral and extended positions. The translation and rotation of the intermedioradiocarpal bone (RCB), ulnar carpal bone, and accessory carpal bone were described relative to the radius through rigid body motion analysis. Kinematic and load analysis was repeated after sequential transection of the PRL and the PUL. RESULTS: Sagittal plane extension with a lesser component of valgus motion was found in all evaluated carpal bones. RCB supination was also detected during extension. Compared with the normal intact limb, transection of either or both the PRL and the PUL did not influence mean translation or rotation data or limb load. However, the transection of the PRL and the PUL increased the variance in rotation data compared with intact limb. CONCLUSION: This study describes normal antebrachiocarpal kinematics as a foundation for determining carpal functional units. During axial loading, the PRL and the PUL may function to guide consistent motion in extension and flexion as well as pronation and supination. CLINICAL SIGNIFICANCE: Three-dimensional carpal kinematic analyses may improve our understanding of carpal injury and facilitate the development of novel treatments techniques.

Teaching Tip: Simulated Tumors as an Aid to Teaching Principles of Surgical Oncology.

Tumors of the skin and subcutaneous tissues are an important cause of morbidity and mortality in small animals. In many cases, surgical excision is an essential component of successful therapy and it should be performed in a specific way based on the type and grade of the tumor. Students require adequate training to develop both clinical decision-making skills and technical surgical skills, which we believe contribute to optimal clinical results. We have developed an inexpensive and simple technique that aims to replicate a naturally occurring subcutaneous tumor and allows trainees to plan and perform three common surgical procedures: incisional biopsy, marginal excision, and wide surgical excision. Artificial tumors were created by subcutaneous injection of a heated, oil-based solution that adhered to surrounding tissue as it solidified. Simulated masses were successfully created in all specimens. Many students performed the exercises with technical proficiency; however, some technical errors were identified and provided an opportunity to discuss the challenges of and solutions to several of these situations. This exercise may be a valuable addition to the veterinary curriculum, aiding student development of both technical skills and knowledge in the field of surgical oncology.

A biomechanical comparison of Kirschner-wire fixation on fracture stability in Salter-Harris type I fractures of the proximal humeral physis in a porcine cadaveric model.

BACKGROUND: The physis is the weakest component of immature long bones, and physeal fractures constitute about 30% of fractures in growing dogs. Fractures of the proximal humeral physis typically have a Salter Harris type I or II configuration. These fractures require accurate reduction and adequate stabilization to allow for any potential continued longitudinal bone growth, in conjunction with physeal fracture healing. Conventional internal fixation of these fractures involves insertion of two parallel Kirschner wires, although other methods described include tension band wiring, Rush pinning, and lag screws. However these recommendations are based on anecdotal evidence, and information about the biomechanical stability of physeal fracture repair is sparse. The unique anatomical structure of the epiphyseal-metaphyseal complex makes the gripping of the epiphysis for ex vivo biomechanical testing of physeal fracture repair very challenging. The objective of our study was to biomechanically assess the optimal number (three, two or one) of implanted Kirschner wires in a porcine Salter Harris I proximal humeral physeal fracture model, using motion analysis tracking of peri-fragmental retro-reflective markers while constructs were subjected to a constant axial compression and a sinusoidal torque of +/- 2 Nm at 0.5 Hz for 250 cycles. RESULTS: There were significant differences between the three constructs (three, two or one Kirschner wire repair) for gross angular displacement (p < 0.001). The difference between three pins and two pins on toggle was not significant (p = 0.053), but both three-pin and two-pin fixation significantly reduced rotational toggle compared to one-pin fixation. Construct stiffness was not significantly different between any of the pin groups (p > 0.33). CONCLUSIONS: Motion analysis tracking using peri-fragmental markers in this porcine model of physeal fracture repair found that the stability at the fracture site of one-pin fixation was significantly less than two-pin and three-pin fixation. Whether there was increased stabilization of these fractures with three-pin fixation compared to two-pin fixation was not conclusive in this porcine model.

Influence of Scan Resolution, Thresholding, and Reconstruction Algorithm on Computed Tomography-Based Kinematic Measurements.

Radiographic data, including computed tomography (CT) and planar X-ray, is increasingly used for human and animal kinematic studies. There is a tendency toward using as high-resolution imaging as possible. Higher resolution imaging is one factor (in conjunction with the reconstruction algorithm), which may increase the precision of reconstructed three-dimensional (3D) surface models in representing true bone shape. However, to date no study has tested the effects of scan resolution, threshold, and 3D model reconstruction algorithm on the accuracy of bone kinematic results. The present study uses a novel method to do this where canine tarsal bones were positioned on a radiolucent Lego™ board and scanned before and after undergoing known translations and/or rotations. The digital imaging and communications in medicine (DICOM) images were acquired using two different CT scanning resolutions and processed using three different segmentation threshold levels and three different reconstruction algorithms. Using one bone as the reference bone, an iterative closest point (ICP) algorithm was used to register bones to a global co-ordinate system and allow measurement of other bone kinematics in terms of translations and rotations in and around the x-, y-, and z-axes. The measured kinematics were compared to the "known" kinematics, which were obtained from the Lego™ board's manufacturing standards and tolerances, to give accuracy error metrics for all bones. The results showed error in accuracy of measured kinematics was at subvoxel levels (less than 0.5 mm). Despite altering the volume and surface area of the 3D bone models, variation in resolution, segmentation threshold and reconstruction algorithm had no significant influence upon the accuracy of the calculated tarsal bone kinematics.

Radiological and clinical outcomes of novel Ti/PEEK combined spinal fusion cages: a systematic review and preclinical evaluation.

PURPOSE: The primary objective of this paper was to provide a systematic review of the available clinical studies of Ti/PEEK combined cages in spinal interbody fusion surgeries, focusing on their radiological and clinical outcomes. A secondary aim was to provide a review and evaluation of the in vitro and preclinical studies reported on Ti/PEEK-coated implants. METHODS: A systematic search of the literature was performed in March 2015 via three databases: Medline, Embase and Cochrane library. The following key search terms were combined with synonyms to identify relevant articles: "spinal fusion," "PEEK," "titanium" and "cage." RESULTS: The novelty of this intervention translates into a paucity of clinical trials, albeit the results of the seven clinical studies that met the criteria for inclusion are promising. All studies reported rate of fusion as a primary outcome. Two studies reported slightly improved fusion in the experimental Ti/PEEK combination cohort, one study identical fusion (91.7 %) and three studies excellent fusion (96, 100 and 94 %) in the Ti/PEEK cohort, although no differences reached statistical significance. CONCLUSIONS: Clinical studies at this early stage demonstrate that Ti/PEEK implants are safe and efficacious, exhibiting similar fusion rates and clinical outcomes compared to the current standard PEEK. There is clinical evidence substantiating the improved radiographic fusion of Ti/PEEK, albeit the differences were not significant. This field is promising, gaining substantial popularity, and further clinical trials are needed in the future to establish Ti/PEEK cages as a mainstay of clinical practice.