Locking plate constructs in subtrochanteric fixation: a biomechanical comparison of LCP screws and AO-nuts.

OBJECTIVES: Various studies have reported the use of the 95-degree condylar blade plate in the treatment of a subtrochanteric fracture or non-union. However, the holding power of standard screws in the metaphyseal and diaphyseal area is often diminished due to osteopenia. The alternative in this area is the use of locking plates, Schühlis or AO-nuts. With the latter two, non-locking screws in the blade plate can be converted to a fixed angle fixation. The objective of this study was to compare the stiffness and strength of the AO-nut augmented 95-degree condylar blade plate construct with that of a locking plate construct. In addition, a clinical series of eight patients treated with the AO-nut augmented 95-degree condylar blade plate construct is presented. METHODS: Single screw-plate constructs of a 5.0 mm locking screw/locking compression plate (LCP) and a 4.5 mm non-locking screw/4.5 mm dynamic compression plate (DCP), converted to a fixed-angle screw construct using AO-nuts, were tested by cantilever bending. During loading, force and displacement were recorded, from which the bending stiffness (N/mm) and the yield strength (N) were determined. Secondarily, all patients that underwent surgical treatment for subtrochanteric fracture, malunion or non-union by the senior author using this technique, underwent chart review. RESULTS: The stiffness of the locking screws was about four times higher compared to the AO-nut augmented construct. The yield strength was 2.3 times higher for the locking screw construct. In none of the eight patients treated with the fixed-angle blade plate, failure of the AO-nut augmented construct occurred. CONCLUSIONS: Although the stiffness and strength of the AO-nut augmented construct is less than of the locking screw, excellent clinical outcomes can be achieved utilizing this construct.

Edge-Dependent Topology in Kekulé Lattices.

The boundary states of topological insulators are thought not to depend on the precise atomic structure of the boundary. A recent theoretical study showed that, for topological crystalline insulators with given bond strengths, topological states should only emerge for certain edge geometries. We experimentally probe this effect by creating artificial Kekulé lattices with different atomically well-defined edge geometries and hopping ratios in a scanning tunneling microscope. Topological edge modes are found to only appear for specific combinations of edge geometry and hopping ratio.

Effect of a titanium cage as a stand-alone device on biomechanical stability in the lumbosacral spine of canine cadavers.

Degenerative lumbosacral stenosis is a common disease in dogs characterised by intervertebral disc herniation, loss of disc height and stenosis. Decompressive dorsal laminectomy and partial discectomy can cause spinal instability and worsen foraminal stenosis. Pedicle screw and rod fixation (PSRF) with an intervertebral body cage allows for distraction and restoration of disc height and restores foraminal apertures. The aim of this study was to evaluate the ex vivo biomechanical properties of a titanium intervertebral cage alone and in combination with PSRF in the lumbosacral spine of dogs. The range of motion, neutral zone, neutral zone stiffness and elastic zone stiffness of the lumbosacral joint (L7-S1) of nine canine cadavers were determined in flexion/extension, lateral bending and axial rotation for four conditions: (1) native (unmodified) spine; (2) dorsal laminectomy and discectomy; (3) stand-alone cage; and (4) cage in combination with PSRF. The intervertebral disc height decreased after dorsal laminectomy, but increased after insertion of the cage. Insertion of the stand-alone cage decreased the range of motion and neutral zone compared to the laminectomy-discectomy and increased neutral zone stiffness in all directions. The range of motion further decreased after PSRF. From a biomechanical point of view, the use of a stand-alone intervertebral cage is a potential alternative to dorsal fixation of the lumbosacral junction, since it increases spinal stability and restores disc height.

Translational challenges for the development of a novel nucleus pulposus substitute: Experimental results from biomechanical and in vivo studies.

Nucleus pulposus replacement therapy could offer a less invasive alternative to restore the function of moderately degenerated intervertebral discs than current potentially destructive surgical procedures. Numerous nucleus pulposus substitutes have already been investigated, to assess their applicability for intradiscal use. Still, the current choice of testing methods often does not lead to efficient translation into clinical application. In this paper, we present the evaluation of a novel nucleus pulposus substitute, consisting of a hydromed core and an electrospun envelope. We performed three mechanical evaluations and an in vivo pilot experiment. Initially, the swelling pressure of the implant was assessed in confined compression. Next, we incorporated the implant into mechanically damaged caprine lumbar intervertebral discs to determine biomechanical segment behaviour in bending and torsion. Subsequently, segments were serially tested in native, damaged and repaired conditions under dynamic axial compressive loading regimes in a loaded disc culture system. Finally, nucleus pulposus substitutes were implanted in a live goat spine using a transpedicular approach. In confined compression, nucleus pulposus samples as well as implants showed some load-bearing capacity, but the implant exhibited a much lower absolute pressure. In bending and torsion, we found that the nucleus pulposus substitute could partly restore the mechanical response of the disc. During dynamic axial compression in the loaded disc culture system, on the other hand, the implant was not able to recover axial compressive behaviour towards the healthy situation. Moreover, the nucleus pulposus substitutes did not remain in place in the in vivo situation but migrated out of the disc area. From these results, we conclude that implants may mimic native disc behaviour in simple mechanical tests, yet fail in other, more realistic set-ups. Therefore, we recommend that biomaterials for nucleus pulposus replacement be tested in testing modalities of increasing complexity and in their relevant anatomical surroundings, for a more reliable prediction of clinical potential.

Comparison of two devices for the treatment of keloid scars with the use of intralesional cryotherapy: An experimental study.

BACKGROUND: Intralesional (IL) cryotherapy is a new technique for the treatment of keloid scars, in which the scar is frozen from inside. Two cryodevices are available, which were recently evaluated. Both devices showed promising results, but differed in clinical outcome. To explain these differences, more understanding of the working mechanism of both devices is required. OBJECTIVE: This experimental study was designed to investigate and compare the thermal behavior of an argon gas- and a liquid nitrogen-based device. Thermal behavior constitutes: (1) minimum tissue temperature (°C), (2) the freezing rate (°C/min). The thermal behavior was measured inside and on the outer surface of the scar. Both devices were tested ex vivo and in vivo. RESULTS: Ex vivo, when determining the maximum freezing capacity, the argon gas device showed a higher end temperature compared to the liquid nitrogen device (argon gas: -120°C, liquid nitrogen: -140°C) and a faster freezing rate (argon gas: -1300°C/min, liquid nitrogen: -145°C/min). In vivo, measured inside the keloid, the argon gas device showed a lower end temperature than the liquid nitrogen device (argon gas: -36.4°C, liquid nitrogen: -8.1°C) and a faster freezing rate (argon gas: -14.7°C/min, liquid nitrogen: -5°C/min). The outer surface of the scar reached temperatures below -20°C with both devices as measured with the thermal camera. CONCLUSION: In conclusion, the argon gas device displayed a lower end temperature and a faster freezing rate in vivo compared to the liquid nitrogen device. Although this resulted in lower recurrence rates for the argon gas device, more hypopigmentation was seen compared to the liquid nitrogen device following treatment. Finally, the low outer surface temperatures measured with both devices, suggest that some hypopigmentation following treatment is inevitable.

Relation between radiological assessment and biomechanical stability of lumbar interbody fusion in a large animal model.

PURPOSE: To relate the progress of vertebral segmental stability after interbody fusion surgery with radiological assessment of spinal fusion. METHODS: Twenty goats received double-level interbody fusion and were followed for a period of 3, 6 and 12 months. After killing, interbody fusion was assessed radiographically by two independent observers. Subsequently, the lumbar spines were subjected to four-point bending and rotational deformation, assessed with an optoelectronic 3D movement registration system. In addition, four caprine lumbar spines were analysed in both the native situation and after the insertion of a cage device, as to mimic the direct post-surgical situation. The range of motion (ROM) in flexion/extension, lateral bending and axial rotation was analysed ex vivo using a multi-segment testing system. RESULTS: Significant reduction in ROM in the operated segments was already achieved with moderate bone ingrowth in flexion/extension (71 % reduction in ROM) and with only limited bone ingrowth in lateral bending (71 % reduction in ROM) compared to the post-surgical situation. The presence of a sentinel sign always resulted in a stable vertebral segment in both flexion/extension and lateral bending. For axial rotation, the ROM was already limited in both native and cage inserted situations, resulting in non-significant differences for all radiographic scores. DISCUSSION: In vivo vertebral segment stability, defined as a significant reduction in ROM, is achieved in an early stage of spinal fusion, well before a radiological bony fusion between the vertebrae can be observed. Therefore, plain radiography underestimates vertebral segment stability.

The feasibility of modal testing for measurement of the dynamic characteristics of goat vertebral motion segments.

Structural vibration testing might be a promising method to study the mechanical properties of spinal motion segments as an alternative to imaging and spinal manipulation techniques. Structural vibration testing is a non-destructive measurement technique that measures the response of a system to an applied vibration as a function of frequency, and allows determination of modal parameters such as resonance frequencies (ratio between stiffness and mass), vibration modes (pattern of motion) and damping. The objective of this study was to determine if structural vibration testing can reveal the resonance frequencies that correspond to the mode shapes flexion-extension, lateroflexion and axial rotation of lumbar motion segments, and to establish whether resonance frequencies can discriminate specific structural alterations of the motion segment. Therefore, a shaker was used to vibrate the upper vertebra of 16 goat lumbar motion segments, while the response was obtained from accelerometers on the transverse and spinous processes and the anterior side of the upper vertebra. Measurements were performed in three conditions: intact, after dissection of the ligaments and after puncturing the annulus fibrosus. The results showed clear resonance peaks for flexion-extension, lateral bending and axial rotation for all segments. Dissection of the ligaments did not affect the resonance frequencies, but puncturing the annulus reduced the resonance frequency of axial rotation. These results indicate that vibration testing can be utilised to assess the modal parameters of lumbar motion segments, and might eventually be used to study the mechanical properties of spinal motion segments in vivo.

Intervertebral disc recovery after dynamic or static loading in vitro: is there a role for the endplate?

In vivo studies on disc mechanics show loss of fluid from the intervertebral disc (IVD) during loading and full recovery during rest. Previous work indicated that in vitro recovery is hampered after static loading. The aim of the present study was to investigate the role of the endplate after dynamic and static loading on mechanical recovery in vitro. Lumbar spines (caprine) were obtained from the local slaughterhouse and stored frozen. Twenty-four intervertebral discs were thawed and subjected to a compression test in a saline bath (37 degrees C). The discs were pre-loaded at 20 N for 15 min. Three 15-min loading cycles (static: 2.0 MPa or dynamic: average load 2.0 MPa at 0.5 Hz) were applied, each followed by a 30-min period of unloading (20 N). After this protocol, the endplates of half of the discs were blocked with silicone paste and the long-term recovery protocol was applied; the discs were subjected to a single loading cycle (15 min of static or dynamic loading) followed by 10h of unloading at 20 N. All specimens showed a net loss of height and a gain in stiffness during the first part of the test. Eventually, height and stiffness were restored during a long-term recovery test. The difference in recovery between blocked and free endplates was marginal. If fluid flow plays a role during recovery in vitro, the role of the endplate appears to be limited. Our findings show no influence of loading type on recovery in vitro.

Biomechanical comparison of hard and soft hip protectors, and the influence of soft tissue.

INTRODUCTION: Hip protectors appear to be promising in preventing hip fractures. Currently, many different hip protectors exist, and it is not clear which hip protector has the best biomechanical properties. Therefore, the objective of this study was to compare the force attenuation capacity of 10 different hip protectors. Both hard hip protectors, which primarily shunt away energy, and soft hip protectors, which primarily absorb energy, were included. METHODS: Using a drop weight impact testing system and a surrogate femur, a weight of 25 kg was dropped from a height of 8 cm causing a force of almost 7,806 N on the bare femur, which simulates a severe fall. After this calibration test, soft tissue and the different hip protectors in combination with the soft tissue were tested. Each test was repeated six times. To simulate normal-weight elderly people, a 1/2-inch-thick layer of foam was chosen, reducing the force by 18%. To examine the influence of soft tissue thickness, soft tissue was also simulated by a 1-inch-thick layer of foam, reducing the force by 49%. RESULTS: In the 1-inch soft tissue test, all hip protectors were capable in reducing the impact to below the average fracture threshold of elderly people (3,100 N), although the hard types performed significantly better than the soft ones (P < 0.001). In the 1/2-inch soft tissue test, only the hard hip protectors were capable of attenuating the peak force to below the average fracture threshold of 3,100 N (hard vs. soft hip protectors: P < 0.001). CONCLUSIONS: This study showed that the hard, energy-shunting hip protectors were superior to the soft, energy-absorbing ones, especially in a simulation of normal-weight elderly people. With increased soft tissue thickness, soft hip protectors were also capable in reducing the impact to below the average fracture threshold of 3,100 N.

A bioresorbable molding mesh for impaction grafting revision hip surgery.

Impacted morselized allografts are used to treat bone loss in revision surgery. This technique depends on adequate mechanical support of the graft. Metal support devices function well, but there are disadvantages associated with the use of steel meshes. In this cadaveric, surgical simulation model we investigated the surgical and mechanical suitability of a bioresorbable molding mesh for use in impaction grafting revision surgery. Surgical feasibility was assessed, and mechanical deformation of the mesh during the surgical procedure and postoperative cyclic loading of the specimens were measured with strain gauges. All meshes were surgically usable. The exterior surface deformation of the meshes during the surgical procedure and postoperative mechanical loading did not exceed 4500 microm/m, although the meshes were not damaged in a four-point bending test in which deformations higher than 19,000 microm/m were reached. Therefore, results of this study suggest that this type of bioresorbable mesh seems to have sufficient initial mechanical properties to warrant additional preclinical in vivo study.

Industrial manufacture of parenteral products in The Netherlands. A survey of eight years of media fills and sterility testing.

Sterility testing and media fills are essential requirements in the pharmaceutical industry. With the results obtained the manufacturer must ensure that the aseptic filling process is under control. In an eight year (1988-1995) retrospective survey of three major Dutch pharmaceutical companies the performance of the sterility test, of media fills and their relationship have been statistically evaluated. The products included human and veterinary pharmaceuticals and biologicals, and were divided into six different groups according to their production process and primary containers. A distinction was made between the results from the period 1985-1991 and the period 1992-1995, because this made the statistical analyses of a number of types of products possible, and because some significant changes in the production process were made in 1991 at some of the production sites. The results of the evaluation of the sterility test show that the frequency of false positives has not changed significantly. The overall rate of false positives of 0.17% is a factor ten better than considered acceptable by USP XXIII. For all product groups the frequency of positive sterility tests has decreased during the period of investigation. During the period 1992-1995 there was no significant difference between the results of product sterility tests and the negative controls for any of the product groups. This indicates that given the present state-of-the-art production the sterility test offers little or no additional security. The overall contamination of the media fills done in the more recent period is a factor twenty better than the limit given in the PDA Technical Monograph No. 2. In the more recent period there is a good agreement between the observed positive rate of the sterility tests and the positive rate that had been estimated from the results of the media fills. This indicates that despite some shortcomings, media fills are an adequate simulation of the production process and can be used to give an estimate of the rejection rate for the various product groups. The overall conclusion is that the production conditions of the participating Dutch pharmaceutical companies comply with the current international guidelines for aseptic production and sterility testing.

The influence of gamma-irradiation upon the chemical and biological properties of insulin.

Partially purified insulin preparations of bovine and porcine origin, were subjected to gamma-irradiation with doses ranging from 1.0 up to 25 kGy (0.1-2.5 Mrad) at 0 degrees C or ambient temperature. The susceptibility of insulin to the irradiation was determined by chromatography, electrophoresis and assay of the biological activity. The sterilizing effect of the gamma-irradiation was investigated for Bacillus pumilus as well as for artificial mixtures of lactose and several bacilli. It is concluded that the sterilizing dose for the investigated insulins was greater than or equal to 2.2 kGy. At doses up to 25 kGy at 0 degree C no specific radiolytic products were detectable, whereas the biological activity was fully retained. The content of dimers and the content of related peptides appeared to increase gradually with the irradiation dose absorbed. No effects of long-term storage could be demonstrated on biological and chemical properties of insulin after 2.2, 4.5 and 7.5 kGy.