Quantification of mechanical properties in long-term in vivo used silicone catheter lines according to DIN 10555-3.

BACKGROUND: Totally implantable central venous access port devices are crucial for intravenous application of chemotherapeutics and long-term therapy for chronic disease. Common complications include thrombosis and device fracture related to altered material properties through exposure in situ. This study exhibits whether uniaxial tensile properties (DIN 10555-3) of in vivo used catheters prove inferior to unused catheters. MATERIAL AND METHODS: 5 unused, originally packed silicone catheters were cut into 6 segments of 50 mm: 3 segments each were cleaned via cleaning solution (n = 15) while 3 segments were left unattended (n = 15). Distal segments (50 mm) of long-term in vivo used silicone catheters were cleaned before testing (n = 33). Overall mechanical behavior was tested in a custom-made self-centering, torsion free carrier. Maximum force stress at failure, strain at failure and Young's modulus were determined and statistically analyzed. FINDINGS: Unused catheters showed no significant difference in testing. in vivo used catheters exhibited 20% lower maximal force than unused catheters (p < 0.001), strain at break (p ã€ˆ0,001), and 7% higher elastic modulus (p = 0.004; power: 0.845). Due to a constant cross section area, stress at failure was proportional to maximum force (p < 0.001). Relation between determined parameters and dwell times was non-significant. INTERPRETATION: In vivo long-term used silicone catheters showed significantly lower ultimate strength than unused ones. It is likely that in situ altering changes the mechanical properties of catheters and may potentially lead to failure.

Acromioclavicular joint suture button repair leads to coracoclavicular tunnel widening.

PURPOSE: Biomechanical evaluation of three different suture button devices used in acromioclavicular joint repair and analysis of their effect on post-testing tunnel widening. METHODS: Eighteen human shoulder girdles were assigned into three groups with a similar mean bone mineral density. Three different single-tunnel acromioclavicular repair devices were tested: (1) AC TightRope® with FiberWire; (2) AC Dog Bone™ Button with FiberTape; (3) Low Profile AC Repair System. Biomechanical testing was performed simulating the complex movement of the distal clavicle as follows. A vertical load of 80 N was applied continuously. The rotation of the clavicle about its long axis was set at 10° anterior and 30° posterior for 2500 cycles at 0.25 Hz. The horizontal translation of the clavicle was set at 6 mm medial and 6 mm lateral for 10,000 cycles at 1 Hz. The coracoclavicular distance was measured before and after testing. After testing, each sample underwent micro-CT analysis. Following 3D reconstruction, the area of the bone tunnels was measured at five defined cross sections. RESULTS: In TightRope® and Dog Bone™ groups, all samples completed testing, whereas in the Low Profile group, three out of six samples showed system failure. The mean absolute difference of coracoclavicular distance after testing was significantly greater in the Low Profile group compared to TightRope® and Dog Bone™ groups (4.3 ± 1.3 mm vs 1.9 ± 0.7 mm vs 1.9 ± 0.8 mm; p = 0.001). Micro-CT analysis of the specimens demonstrated significant tunnel widening in the inferior clavicular and superior coracoid regions in all three groups (p < 0.05). CONCLUSION: Significant tunnel widening can be observed for all devices and is primarily found in the inferior parts of the clavicle and superior parts of the coracoid. The Low Profile AC Repair System showed inferior biomechanical properties compared to the AC TightRope® and AC Dog Bone™ devices. Therefore, clinicians should carefully select the type of acromioclavicular repair device used and need to consider tunnel widening as a complication.

All-suture anchor pullout results in decreased bone damage and depends on cortical thickness.

PURPOSE: To evaluate the influence of cortical and cancellous bone structure on the biomechanical properties of all-suture and conventional anchors and compare the morphological bone damage after their failure. The hypothesis of the study is that all-suture anchor pullout is less invasive and that the pullout force is influenced by the cortical thickness. METHODS: Thirty human humeri were biomechanically tested as follows: starting with a load cycle from 20 to 50 N, a stepwise increase of the upper peak force by 0.05 N for each cycle at a rate of 1 Hz was performed. Analysis included maximum pullout strength for three different anchor implantation angles (45°, 90°, 110°) of the two anchor types. After anchor pullout, every sample underwent micro-CT analysis. Bone mineral density (BMD) and cortical thickness were determined at the anchor implantation site. Furthermore, the diameter of the cortical defect and the volume of the bone cavity were identified. RESULTS: The maximum pullout strength of all-suture anchors demonstrates a strong correlation to the adjacent cortical thickness (r = 0.82, p ≤ 0.05) with at least 0.4 mm needed to withstand 200 N. No correlation could be seen in conventional anchors. Moreover, no correlation could be detected for local BMD in both anchors. All-suture anchors show a significantly narrower cortical defect as well as a smaller bone cavity following pullout (4.3 ± 1.3 mm vs. 5.3 ± 0.9 mm, p = 0.037; 141 mm3 vs. 212 mm3; p = 0.009). The cortical defect is largest if the anchors are placed at a 45° angle. CONCLUSION: In contrast to conventional anchors, the pullout force of all-suture anchors depends on the thickness of the humeral cortex. Furthermore, all-suture anchors show a significantly smaller cortical defect as well as decreased bone damage in the case of pullout. Therefore, the clinical implication of this study is that all-suture anchors are advantageous due to their bone preserving ability. Also, intraoperative decortication should not be performed and cortical thickness should be preoperatively evaluated to decrease the risk of anchor failure.

Biomechanical comparison of polylactide-based versus titanium miniplates in mandible reconstruction in vitro.

OBJECTIVES: Evaluation of the mechanical integrity and reliability of polylactide-based miniplates for osseous free flap fixation at the mandible in an experimental study setup of a mandible reconstruction model. MATERIAL AND METHODS: 1.0mm titanium miniplates (group TI) (MatrixMandible, DePuy Synthes, Umkirch, Germany) and 1.5mm polylactide miniplates (group PL) (Inion CPS, Inion Oy, Tampere, Finland) were used to fix a polyurethane (PU) fibula segment to a PU mandible reconstruction model using monocortical non-locking screws. Mastication was simulated via unilateral cyclic dynamic loading at 1Hz with increasing loads (+ 0.15N/cycle, Bionix, MTS, USA). A 3D optical tracking system (Aramis, GOM, Braunschweig, Germany) was used to determine interosteotomy movements (IOM). RESULTS: IOM were higher in the polylactide group (distal: P=0.001, mesial: P=0.001). Differences in mean stiffness (titanium: 478±68N/mm; polylactide: 425±38N/mm, P=0.240) and mean force at a vertical displacement of 1.0mm (titanium: 201.6±87.1N; polylactide: 141.3±29.9N, P=0.159) were not significant. CONCLUSIONS: The results of this study suggest that polylactide-based miniplates provide reduced mechanical integrity and higher interosteotomy movements in comparison to titanium miniplates in vitro. Indications for clinical use of polylactide-based miniplates in mandible reconstruction have to be placed critically. Future studies will focus on clinical complications of polylactide-based plates in risk patients.

Test method for mechanical properties of implantable catheters according to DIN 10555-3.

To enable causal analysis of port catheter failure, this study aimed to develop an experimental setup for uniaxial tensile tests that addresses the specific requirements of highly elastic medical catheters; and to quantify parameters of the catheters' mechanical competence with respect to effects of artificial aging. Segments of 6F-polyurethane catheters were tested in their native status, after chemical and after mechanical aging. Tension experiments were performed with a rate of 220 mm/min until catheter failure. Material behavior was analyzed based on load cell measurements of the universal test system and an additional optical distance registration. The Young's modulus, the ultimate stress and the ultimate strain were determined. Chemical aging significantly decreased Young's modulus (84%; p = 0.001) and ultimate stress (83%; p < 0.001), whereas mechanical aged samples demonstrated similar results for the Young's modulus (p = 0.772) and a non-significant rise of ultimate stress (13%; p = 0.128). Ultimate strain did not differ significantly regardless of the pretreatment. The results proof reliability, reproducibility and sensitivity to quantify artificial aging induced variations and also promise to detect deviations in material features caused by long-term clinical usage of catheters.

Cement augmentation versus extended dorsal instrumentation in the treatment of osteoporotic vertebral fractures: a biomechanical comparison.

AIMS: Loosening of pedicle screws is a major complication of posterior spinal stabilisation, especially in the osteoporotic spine. Our aim was to evaluate the effect of cement augmentation compared with extended dorsal instrumentation on the stability of posterior spinal fixation. MATERIALS AND METHODS: A total of 12 osteoporotic human cadaveric spines (T11-L3) were randomised by bone mineral density into two groups and instrumented with pedicle screws: group I (SHORT) separated T12 or L2 and group II (EXTENDED) specimen consisting of T11/12 to L2/3. Screws were augmented with cement unilaterally in each vertebra. Fatigue testing was performed using a cranial-caudal sinusoidal, cyclic (1.0 Hz) load with stepwise increasing peak force. RESULTS: Augmentation showed no significant increase in the mean cycles to failure and fatigue force (SHORT p = 0.067; EXTENDED p = 0.239). Extending the instrumentation resulted in a significantly increased number of cycles to failure and a significantly higher fatigue force compared with the SHORT instrumentation (EXTENDED non-augmented + 76%, p < 0.001; EXTENDED augmented + 87%, p < 0.001). CONCLUSION: The stabilising effect of cement augmentation of pedicle screws might not be as beneficial as expected from biomechanical pull-out tests. Lengthening the dorsal instrumentation results in a much higher increase of stability during fatigue testing in the osteoporotic spine compared with cement augmentation. Cite this article: Bone Joint J 2016;98-B:1099-1105.

Biomechanical modelling of impact-related fracture characteristics and injury patterns of the cervical spine associated with riding accidents.

BACKGROUND: Horse-related injuries are manifold and can involve the upper and lower limbs, the trunk, spine or head. Cervical spine injuries are not among the most common injuries. However, they can be fatal and often result in neurological symptoms. This study investigated the influence of the posture of the cervical spine on the ultimate strength and the pattern of vertebrae failure with the aim to provide some guidance for protective clothing design. METHODS: Eighteen human cervical spines, each divided into two specimens (three vertebrae each), were subjected to a simulator test designed to mimic a spinal trauma in different postures of the specimen (neutral, flexion, extension). The stress-to-failure, the deformation at the time of fracture and the fracture patterns assessed based on CT scans were analysed. FINDINGS: Stress-to-failure of the superior specimens was lower for the flexion group compared to the others (P=0.027). The superior specimens demonstrated higher stress-to-failure in comparison to the inferior specimens (P<0.001). Compression in a neutral or flexed position generated mild or moderate fracture patterns. On the contrary, the placement of the spine in extension resulted in severe fractures mostly associated with narrowing of the spinal canal. INTERPRETATION: The results imply that a neutral cervical spine position during an impaction can be beneficial. In this position, the failure loads are high, and even if a vertebral fracture occurs, the generated injury patterns are expected to be mild or moderate.

The role of patient-mode high-resolution peripheral quantitative computed tomography indices in the prediction of failure strength of the elderly women's thoracic vertebral body.

UNLABELLED: The correlations between the failure load of 20 T12 vertebral bodies, their patient-mode high-resolution peripheral quantitative computed tomography (HR-pQCT) indices, and the L1 areal bone mineral density (aBMD) were investigated. For the prediction of the T12 vertebral failure load, the T12 HR-pQCT microarchitectural parameters added significant information to that of L1 aBMD and to that of cortical BMD, but not to that of T12 vertebral BMD and not to that of T12 trabecular BMD. INTRODUCTION: HR-pQCT is a new in vivo imaging technique for assessing the three-dimensional microarchitecture of cortical and trabecular bone at the distal radius and tibia. But little is known about this technique in the direct measurement of vertebral body. METHODS: Twenty female donors with the mean age of 80.1 (7.6) years were included in the study. Dual X-ray absorptiometry of the lumbar spine and femur was performed. The spinal specimens (T11/T12/L1) were dissected, scanned using HR-pQCT scanner, and mechanically tested under 4° wedge compression. The L1 aBMD, T12 patient-mode HR-pQCT indices, and T12 vertebral failure loads were analyzed. RESULTS: For the prediction of vertebral failure load, the inclusion of BV/TV into L1 aBMD was the best model (R (2) = 0.52), Tb.N and Tb.Sp added significant information to the L1 aBMD and to the cortical BMD, but none of the vertebral microarchitectural parameters yielded additional significant information to the trabecular BMD (or BV/TV) and to the vertebral BMD. CONCLUSION: Vertebral microarchitectural parameters obtained from the patient-mode HR-pQCT analysis provide significant information on bone strength complementary to that of aBMD and to that of cortical BMD, but not to that of vertebral BMD and not to that of trabecular BMD.

The role of inter-prosthetic distance, cortical thickness and bone mineral density in the development of inter-prosthetic fractures of the femur: a biomechanical cadaver study.

It is becoming increasingly common for a patient to have ipsilateral hip and knee replacements. The inter-prosthetic (IP) distance, the distance between the tips of hip and knee prostheses, has been thought to be associated with an increased risk of IP fracture. Small gap distances are generally assumed to act as stress risers, although there is no real biomechanical evidence to support this. The purpose of this study was to evaluate the influence of IP distance, cortical thickness and bone mineral density on the likelihood of an IP femoral fracture. A total of 18 human femur specimens were randomised into three groups by bone density and cortical thickness. For each group, a defined IP distance of 35 mm, 80 mm or 160 mm was created by choosing the appropriate lengths of component. The maximum fracture strength was determined using a four-point bending test. The fracture force of all three groups was similar (p = 0.498). There was a highly significant correlation between the cortical area and the fracture strength (r = 0.804, p < 0.001), whereas bone density showed no influence. This study suggests that the IP distance has little influence on fracture strength in IP femoral fractures: the thickness of the cortex seems to be the decisive factor.

Design parameters and the material coupling are decisive for the micromotion magnitude at the stem-neck interface of bi-modular hip implants.

Several bi-modular hip prostheses exhibit an elevated number of fretting-related postoperative complications most probably caused by excessive micromotions at taper connections. This study investigated micromotions at the stem-neck interface of two different designs: one design (Metha, Aesculap AG) has demonstrated a substantial number of in vivo neck fractures for Ti-Ti couplings, but there are no documented fractures for Ti-CoCr couplings. Conversely, for a comparable design (H-Max M, Limacorporate) with a Ti-Ti coupling only one clinical failure has been reported. Prostheses were mechanically tested and the micromotions were recorded using a contactless measurement system. For Ti-Ti couplings, the Metha prosthesis showed a trend towards higher micromotions compared to the H-Max M (6.5 ± 1.6 µm vs. 3.6 ± 1.5 µm, p=0.08). Independent of the design, prostheses with Ti neck adapter caused significantly higher interface micromotions than those with CoCr ones (5.1 ± 2.1 µm vs. 0.8 ± 1.6 µm, p=0.001). No differences in micromotions between the Metha prosthesis with CoCr neck and the H-Max M with Ti neck were observed (2.6 ± 2.0 µm, p=0.25). The material coupling and the design are both crucial for the micromotions magnitude. The extent of micromotions seems to correspond to the number of clinically observed fractures and confirm the relationship between those and the occurrence of fretting corrosion.

Cement augmentation of the proximal femoral nail antirotation for the treatment of osteoporotic pertrochanteric fractures--a biomechanical cadaver study.

INTRODUCTION: Proximal femoral fractures will gain increasing importance in the future due to the epidemiological development. Osteoporosis is often a limiting factor in the achievement of implant stability. New nailing systems offer the possibility of augmentation of the femoral neck component with cement. The aim of this study was to perform a biomechanical comparison of implant stability in osteoporotic pertrochanteric fractures using the proximal femoral nail antirotation (PFNA, Synthes GmbH, Umkirch, Germany) with cement augmented and non-augmented blades. MATERIALS AND METHODS: Bone mineral density (BMD) was measured by dual-energy X-ray absorptiometry (DEXA) in six pairs of fresh-frozen human femurs. Standardised pertrochanteric fractures (AO31-A2.3) were treated with a PFNA. Cement augmentation was performed in six constructs. Axial loading was applied according to a single-leg-stance model using a hydraulic testing machine increasing to 1400N over 10,000 cycles. Biomechanical comparisons between the two groups that were comparable concerning BMD, tip-apex-distance and native stiffness were made with regard to postoperative stiffness, survived cycles, load to failure, failure mechanism and axial displacement. RESULTS: The stiffness of all stabilised femurs was significantly lower than for native specimens (native 702.5±159.6N/mm vs. postoperative 275.4±53.8N/mm, p<0.001). Stiffness after instrumentation was significantly greater for the cement augmented group than for the non-augmented group (300.6±46.7N/mm vs. 250.3±51.6N/mm, respectively, p=0.001). Five of the twelve constructs survived cyclic testing. Statistically significant differences of the BMD were detected between survived and failed constructs (0.79±0.17g/cm(2) vs. 0.45±0.12g/cm(2), respectively, p=0.028). The failure loads for specimens surviving 10,000 cycles were 4611.9±2078.9N in the cement augmented group (n=3) and 4516.3N and 3253.5N in the non-augmented group (n=2). Postoperative stiffness was found to be a positive predictor of maximum force to failure (R(2)=0.83, p=0.02). CONCLUSIONS: The results of this biomechanical study show that cement augmentation of the PFNA increases the implant stability in osteoporotic pertrochanteric fractures. Further studies are necessary to evaluate this procedure in providing long term clinical results.

Migration of two different cementless hip arthroplasty stems in combination with two different heads: a biomechanical in vitro study.

The aim of the present in vitro study was to evaluate migrational characteristics of cementless primary hip arthroplasty stems in combination with a diameter 50 mm head (hemiarthroplasty) and a diameter 28 mm head in and with a polyethylene cup (total hip arthroplasty) in fresh-frozen human specimens. Two different types (Endo SL, FMT) were implanted into seven pairs of fresh-frozen human femoral specimens. The implanted stems were combined with a diameter 50 mm head (hemiarthroplasty) on one side and with a polyethylene cup and a 28 mm head (total hip arthroplasty) on the other side. Dynamic mechanical loading was applied for 50,000 cycles while recording relative motions between stem and bone stock using a 3-D motion analysis system. The Endo SL stem showed a significantly higher amplitude of relative motion in all translational and rotational components regardless of the head used. In both stem types a strong tendency for higher axial migration with the diameter 50 mm head in comparison to the THA head was found. The lowest axial migration was found in the FMTstem in combination with the small head and a PE cup. The highest axial migration was found in the Endo SL stem combined with the diameter 50 mm head. Our results indicate that the head might play an important role for axial migration of cementless stems.

[Comparison of different vertebral body prosthesis with reference to migration and primary stability in dorsoventral spondylodesis after corporectomy with and without laminectomy]. / Vergleich unterschiedlicher Wirbelkörperersatzsysteme hinsichtlich Migration und Primärstabilität bei dorsoventraler Spondylodese nach Korporektomie mit und ohne Laminektomie.

In order to allow speedy mobilization after vertebral body replacement, high primary stability as well as prevention of implant dislocation are required. It is unclear whether differences between common vertebral body replacement systems exist and whether spreadable implants improve primary stability. Migration characteristics of 3 different vertebral body replacement systems were determined using human lumbar spine specimens. Primary stability was assessed by loading specimens successively in 5 conditions: native, after dorsal spondylodesis, after laminectomy and after vertebral body replacement. Migration was shown to depend on cage design and spike shape. Dorsal spondylodesis in combination with vertebral body replacement reduced flexion/extension movement effectively independent of cage design. Stabilization potential in lateral bending was limited. None of the cages limited movement under torsional loading effectively. The possibility to spread the cage had a positive effect on stabilization.

[Placement of pedicle screws using different navigation systems. A laboratory trial with 12 spinal preparations]. / Einbringung von Pedikelschrauben unter Einsatz unterschiedlicher Unterstützungsverfahren. Ein Laborversuch an 12 Wirbelsäulenpräparaten.

A well-known problem occurring with thoracolumbar spondylodesis is the perforation of pedicle screws through the pedicle wall. It occurs in up to 40% of the implanted screws. To reduce this problem, computed tomography (CT)-based navigation systems have been introduced, which allow the surgeon multidimensional control of the screw position in virtual reality and real time during insertion. In the recent past, fluoroscopy-based navigation systems have also been built. We inserted 77 pedicle screws in human lumbar cadaveric spine specimens either without navigation, with CT-based navigation, or with fluoroscopy-based navigation. In the critical sizes of pedicles between 6.5 and 9 mm, we found the best results with CT-based navigation, but there was no significant difference between the three methods. The minimal pedicle and the screw diameters should be reported in every study on pedicle screw misplacement and spine navigation since they represent the most important factor in pedicle wall perforations.

[Definition of pedicle malposition. Primary stability and loosening characteristics of pedicle screws in relation to position: spongious anchoring, cortical anchoring, perforation and malposition]. / Zur Definition der Pedikelfehllage. Primärstabilität und Lockerungsverhalten von Pedikelschrauben in Abhängigkeit von ihrer Lage: spongiöse Verankerung, kortikale Verankerung, Perforation und Fehllage.

Totally misplaced pedicle screws will lead to major stability problems. There are no publications about the stability behavior of screws, which have no pure trabecular position and perforate the pedicle slightly. Since neurological problems are only described with screws perforating the pedicle medially by at least 4 mm, this question has great relevance concerning the definition of pedicular malposition. Sixty-eight pedicle screws were tested in human cadaveric lumbar spines. Their vertical path was measured at the beginning and end of 1000 sinusoidal cycles with a force amplitude of 160 N. They were divided into four groups according to their screw position as mentioned in the title. We found no significant differences in primary stability or loosening between the groups. The cortical contact and perforation groups had slightly better results, which were not significant in comparison to the other two groups.