Biomechanical performance of the Actifit® scaffold is significantly improved by selection of irrigation fluid.

PURPOSE: Clinical reports on meniscal scaffolds seem promising, albeit relatively paucity exists regarding their biomechanical behavior. The aim of the study is to delineate the impact of differing suture materials and the type as well as the temperature of the irrigation fluid on the pull-out strength of a polyurethane meniscal scaffold (Actifit®). MATERIALS AND METHODS: 128 specimens were utilized with horizontal sutures and uniaxial load-to-failure testing was performed. We compared two different suture materials-polydioxanone (PDS) and non-absorbable, braided polyester sutures (NABP)-as well as two common irrigation fluids-lactated Ringer's and electrolyte-free, hypotonic Mannitol-Sorbitol. All specimens were further evaluated according to two different temperatures [room temperature (20 °C) and near-core body temperature (37 °C)]. RESULTS: Mean load-to-failure was 53.3 ± 6.5 N. There was no significant difference between the NABP and the PDS group. Ringer group showed a significantly higher load-to-failure compared to Purisole (P = .0002). This was equivalent for both PDS (P = .0008) and NABP sutures (P = .0008). Significantly higher failure loads could be established for the 37° group (P = .041); yet, this difference was neither confirmed for the PDS or in in the NABP subgroup. Only the subgroup using Purisole at 37° showed significantly higher failure loads compared to 20° (P = .017). CONCLUSIONS: This study underlines the potential to improve pull-out strength during implantation of an Actifit® scaffold by alteration of the type of irrigation fluid. Lactated Ringer solution provided the highest construct stability in regard to load-to-failure testing and should be considered whenever implantation of a polyurethane meniscal scaffold is conducted.

Establishment of a preclinical ovine screening model for the investigation of bone tissue engineering strategies in cancellous and cortical bone defects.

BACKGROUND: New tissue engineering strategies for bone regeneration need to be investigated in a relevant preclinical large animal model before making the translation into human patients. Therefore, our interdisciplinary group established a simplified large animal screening model for intramembranous bone defect regeneration in cancellous and cortical bone. METHODS: Related to a well-established model of cancellous drill hole defect regeneration in sheep, both the proximal and distal epimetaphyseal regions of the femur and the humerus were used bilaterally for eight drill hole cancellous defects (Ø 6 mm, 15 mm depth). Several improvements of the surgical procedure and equipment for an easier harvest of samples were invented. For the inclusion of cortical defect regeneration, a total of eight unicortical diaphyseal drill holes (6 mm Ø) were placed in the proximal-lateral and distal-medial parts of the metacarpal (MC) and metatarsal (MT) diaphyseal bone bilaterally. Acting moments within a normal gait cycle in the musculoskeletal lower limb model were compared with the results of the biomechanical in vitro torsion test until failure to ensure a low accidental fracture risk of utilized bones (ANOVA, p < 0.05). The model was tested in vivo, using thirteen adult, female, black-face sheep (Ø 66 kg; ± 5 kg; age ≥ 2.5 years). In a two-step surgical procedure 16 drill holes were performed for the investigation of two different time points within one animal. Defects were left empty, augmented with autologous cancellous bone or soft bone graft substitutes. RESULTS: The in vitro tests confirmed this model a high comparability between drilled MC and MT bones and a high safety margin until fracture. The exclusion of one animal from the in vivo study, due to a spiral fracture of the left MC bone led to a tolerable failure rate of 8 %. CONCLUSIONS: As a screening tool, promising biomaterials can be tested in this cancellous and cortical bone defect model prior to the application in a more complex treatment site.

Clinical and Technical Validation of Novel Bite Force Measuring Device for Functional Analysis after Mandibular Reconstruction.

Bite force measuring devices that are generally suitable for edentulous patients or patients undergoing mandibular reconstruction are missing. This study assesses the validity of a new bite force measuring device (prototype of loadpad®, novel GmbH) and evaluates its feasibility in patients after segmental mandibular resection. Accuracy and reproducibility were analyzed with two different protocols using a universal testing machine (Z010 AllroundLine, Zwick/Roell, Ulm, Germany). Four groups were tested to evaluate the impact of silicone layers around the sensor: no silicone ("pure"), 2.0 mm soft silicone ("2-soft"), 7.0 mm soft silicone ("7-soft") and 2.0 mm hard silicone ("2-hard"). Thereafter, the device was tested in 10 patients prospectively who underwent mandibular reconstruction using a fibula free flap. Average relative deviations of the measured force in relation to the applied load reached 0.77% ("7-soft") to 5.28% ("2-hard"). Repeated measurements in "2-soft" revealed a mean relative deviation of 2.5% until an applied load of 600 N. Maximum bite force decreased postoperatively by 51.8% to a maximum mean bite force of 131.5 N. The novel device guarantees a high accuracy and degree of reproducibility. Furthermore, it offers new opportunities to quantify perioperative oral function after reconstructive surgery of the mandible also in edentulous patients.

Biomechanical Comparison of WE43-Based Magnesium vs. Titanium Miniplates in a Mandible Fracture Model in Sheep.

In fractures of the mandible, osteosynthesis with titanium plates is considered the gold standard. Titanium is an established and reliable material, its main disadvantages being metal artefacts and the need for removal in case of osteosynthesis complications. Magnesium, as a resorbable material with an elastic modulus close to cortical bone, offers a resorbable alternative osteosynthesis material, yet mechanical studies in mandible fracture fixation are still missing. The hypothesis of this study was that magnesium miniplates show no significant difference in the mechanical integrity provided for fracture fixation in mandible fractures under load-sharing indications. In a non-inferiority test, a continuous load was applied to a sheep mandible fracture model with osteosynthesis using either titanium miniplates of 1.0 mm thickness (Ti1.0), magnesium plates of 1.75 mm (Mg1.75), or magnesium plates of 1.5 mm thickness (Mg1.5). No significant difference (p > 0.05) was found in the peak force at failure, stiffness, or force at vertical displacement of 1.0 mm between Mg1.75, Mg1.5, and Ti1.0. This study shows the non-inferiority of WE43 magnesium miniplates compared to the clinical gold standard titanium miniplates.

Release of different amphotericin B formulations from PMMA bone cements and their activity against Candida biofilm.

Amphotericin B is used for local delivery from polymethylmethacrylate to treat fungal prosthetic joint infections. The optimal amphotericin B formulation and the influence of different poragens in the bone cements are unknown. To investigate the necessary amount of amphotericin B in the bone cement to prevent Candida biofilm several amphotericin B formulations were studied: non-liposomal and liposomal with or without poragen gentamicin. For the non-liposomal formulation, standard bile salt, the sodium deoxycholate, was used and additionally N-methyl-D-glucamine/palmitate was applied. The activity of the released amphotericin B was tested against C. albicans, C. glabrata, C. parapsilosis and C. krusei biofilms with application of the isothermal calorimeter and standard microbiological methods. Compressive strength was measured before and after antifungal elution from the cements. There is less aggregated N-methyl-D-glucamine/palmitate amphotericin B released but its antifungal activity is equivalent with the deoxycholate amphotericin B. The minimum quantity of antifungal preventing the Candida biofilm formation is 12.5 mg in gram of polymer powder for both non-liposomal formulations. The addition of gentamicin reduced the release of sodium deoxycholate amphotericin B. Gentamicin can be added to N-methyl-D-glucamine/palmitate amphotericin B in order to boost the antifungal release. When using liposomal amphotericin B more drug is released. All amphotericin B formulations were active against Candida biofilms. Although compressive strength slightly decreased, the obtained values were above the level of strength recommended for the implant fixation. The finding of this work might be beneficial for the treatment of the prosthetic joint infections caused by Candida spp.

Bioactive coating of zirconia toughened alumina ceramic implants improves cancellous osseointegration.

Bioactive coatings have the potential to improve the bony integration of mechanically loaded orthopedic ceramic implants. Using the concept of mimicking the natural bone surface, four different coatings of varying thickness on a zirconia toughened alumina (ZTA) ceramic implant were investigated regarding their osseointegration in a drill-hole model in sheep. The hypothesis that a bioactive coating of ZTA ceramics would facilitate cancellous bone integration was investigated. The bioactive coatings consisted of either a layer of covalently bound multi phosphonate molecules (chemical modification = CM), a nano hydoxyapatite coating (HA), or two different bioactive glass (BG) coatings in micrometer thickness, forming a hydroxyl-carbonate apatite layer on the implant surface in vivo (dip-coated 45S5 = DipBG; sol-gel 70S30C = SGBG). Coated surfaces were characterized by scanning electron microscopy and X-ray photoelectron spectroscopy. After 12 weeks, osseointegration was evaluated via mechanical push-out testing and histology. HA enhanced the maximum push-out force (HA: mean 3573.85 ± 1119.91 N; SGBG: mean 1691.57 ± 986.76 N; p = 0.046), adhesive shear strength (HA: mean 9.82 ± 2.89 MPA; SGBG: mean 4.57 ± 2.65 MPA; p = 0.025), and energy release rate (HA: mean 3821.95 ± 1474.13 J/mm2; SGBG: mean 1558.47 ± 923.47 J/mm2; p = 0.032) compared to SGBG. The implant-bone interfacial stiffness increased by CM compared to SGBG coating (CM: mean 6258.06 ± 603.80 N/mm; SGBG: mean 3565.57 ± 1705.31 n/mm; p = 0.038). Reduced mechanical osseointegration of SGBG coated implants could be explained histologically by a foreign body reaction surrounding the implants.

Is there a Difference in Interfragmentary Compression Strength Between Fully or Partially Threaded Screws? Results of an Experimental Biomechanical Pilot Study / Há diferença na força de compressão interfragmentar entre parafusos com rosca total ou parcial? Resultados de um estudo biomecânico experimental piloto

Abstract Objective This study assessed differences between fully- and partially-threaded screws in the initial interfragmentary compression strength. Our hypothesis was that there would be an increased loss in initial compression strength with the partially-threaded screw. Methods A 45-degree oblique fracture line was created in artificial bone samples. The first group (FULL, n = 6) was fixed using a 3.5-mm fully-threaded lag screw, while the second group (PARTIAL, n = 6) used a 3.5-mm partially-threaded lag screw. Torsional stiffness for both rotational directions were evaluated. The groups were compared based on biomechanical parameters: angle-moment-stiffness, time-moment-stiffness, maximal torsional moment (failure load), and calibrated compression force based on pressure sensor measurement. Results After loss of one PARTIAL sample, no statistically significant differences in calibrated compression force measurement were observed between both groups: [median (interquartile range)] FULL: 112.6 (10.5) N versus PARTIAL: 106.9 (7.1) N, Mann-Whitney U-test: p = 0.8). In addition, after exclusion of 3 samples for mechanical testing (FULL n = 5, PARTIAL n = 4), no statistically significant differences were observed between FULL and PARTIAL constructs in angle-moment-stiffness, time-moment-stiffness, nor maximum torsional moment (failure load). Conclusion There is no apparent difference in the initial compression strength (compression force or construct stiffness or failure load) achieved using either fully-or partially-threaded screws in this biomechanical model in high-density artificial bone. Fully-threaded screws could, therefore, be more useful in diaphyseal fracture treatment. Further research on the impact in softer osteoporotic, or metaphyseal bone models, and to evaluate the clinical significance is required.

Resumo Objetivo Este estudo avaliou diferenças entre parafusos com rosca total ou parcial na resistência à compressão interfragmentar inicial. Nossa hipótese era de que haveria maior perda de resistência à compressão inicial com o parafuso de rosca parcial. Métodos Uma linha de fratura oblíqua de 45 graus foi criada em amostras de osso artificial. O primeiro grupo (TOTAL, n = 6) foi fixado com um parafuso de 3,5 mm de rosca total, enquanto o segundo grupo (PARCIAL, n = 6) usou um parafuso de 3,5 mm de rosca parcial. Avaliamos a rigidez à torção em ambas as direções de rotação. Os grupos foram comparados com base nos seguintes parâmetros biomecânicos: momento de rigidez-ângulo, momento de rigidez-tempo, momento de torção máxima (carga de falha) e força de compressão calibrada com base na medida do sensor de pressão. Resultados Depois da perda de uma amostra PARCIAL, não foram observadas diferenças estatisticamente significativas na força de compressão calibrada entre os 2 grupos [mediana (intervalo interquartil)]: TOTAL: 112,6 (10,5) N e PARCIAL: 106,9 (7,1) N, com p = 0,8 segundo o teste U de Mann-Whitney). Além disso, após a exclusão de 3 amostras para testes mecânicos (TOTAL, n = 5, PARCIAL, n = 4), não foram observadas diferenças estatisticamente significativas entre os construtos TOTAL e PARCIAL quanto ao momento de rigidez-ângulo, momento de rigidez-tempo ou momento de torção máxima (carga de falha). Conclusão Não há diferença aparente na força de compressão inicial (força de compressão ou rigidez do construto ou carga de falha) com o uso de parafusos de rosca total ou parcial neste modelo biomecânico em osso artificial de alta densidade. Parafusos de rosca total podem, portanto, ser mais úteis no tratamento de fraturas diafisárias. Mais pesquisas são necessárias sobre o impacto em modelos ósseos osteoporóticos ou metafisários de menor densidade e avaliação do significado clínico.

Biomechanical performance of a collagen meniscus implant with regard to suture material and irrigation fluid.

BACKGROUND: The role of meniscus scaffolds remains controversial as failure rates remain high. The aim of this study was to evaluate the pullout strength of different suture materials used for fixation of the Collagen Meniscus Implant (CMI) regarding different suture materials, and type or temperature of irrigation fluid. METHODS: One-hundred and twelve specimens were utilized with horizontal sutures and mounted to a dedicated test device. Loads were applied perpendicular to the CMI, until failure. Two differing suture materials - polydioxanone (PDS) and non-absorbable, braided polyester sutures (NABP) - were evaluated. Additionally, two common irrigation fluids - lactated Ringer's and electrolyte-free, hypotonic Mannitol-Sorbitol solution - were evaluated. Specimens were further evaluated according to different temperatures of the irrigation fluid. Half of the constructs were tested at room temperature (20°C) and half were evaluated at near-core body temperature (37°C). RESULTS: PDS sutures showed a significantly higher load-to-failure compared to NABP sutures (P=0.0008). Regarding the type of irrigation fluid, the electrolyte-free Mannitol-Sorbitol solution showed a significantly higher load-to-failure compared to the overall Ringer group (P b 0.0001). This was equivalent for both the PDS (P=0.015) and for the NABP sutures (P b 0.0001). The temperature of the irrigation fluid did not significantly influence load-to-failure. CONCLUSIONS: PDS sutures and electrolyte-free Mannitol-Sorbitol irrigation fluid provided the best biomechanical properties regarding load-to-failure testing. This study underlines the potential to improve construct stability for the CMI by alteration of the suture material and the type of irrigation fluid, which should be considered whenever scaffold fixation is conducted.