Biomechanical evaluation of a novel fenestrated pedicle screw augmented with bone cement in osteoporotic spines.

STUDY DESIGN: Comparative biomechanical study was conducted in osteoporotic human cadaveric spines. OBJECTIVE: Determine the influence of the volume of polymethyl methacrylate injected through a fenestrated pedicle screw on the pullout strength and on the ability to safely remove the implant. SUMMARY OF BACKGROUND DATA: Pedicle screw fixation in the osteoporotic spine can be improved by the addition of bone cement. Various injection techniques have been used. While improvement has been shown for the pullout strength, the optimal volume of cement to inject has not been previously studied. METHODS: Seven osteoporotic spines were instrumented with a standard and a fenestrated pedicle screw augmented with polymethyl methacrylate at each level (T7-L5). Three volumes of bone cement were randomly injected and stratified to the thoracic (0.5 cc, 1.0 cc, and 1.5 cc) and lumbar spine (1.5 cc, 2.0 cc, and 2.5 cc). Axial pullout strength and removal torque of the pedicle screws were quantified. RESULTS: The pullout strength of the fenestrated screw was normalized with respect to its contralateral control. Student paired t tests were conducted and a statistically significant increase was noted for 1.0 cc (186 ± 45%) and 1.5 cc (158 ± 46%) in the thoracic spine and for 1.5 cc (264 ± 193%), 2.0 cc (221 ± 93%), and 2.5 cc (198 ± 42%) in the lumbar spine. There was no significant difference with higher volumes of cement. The median removal torque was 0.34 Nm for the standard and 1.83 Nm for the augmented screws. When the augmented implants were removed, the bone cement sheared completely off at the fenestrations in 15 of the 17 cases. CONCLUSION: Significant increases in pullout strength can be accomplished by injecting a limited quantity of bone cement through a fenestrated screw while minimizing the risks associated with higher volume. The majority of implants were removed without damaging the vertebra as the bone cement sheared off at the fenestrations.

Surface slide track mapping of implants for total disc arthroplasty.

Total disc arthroplasty has recently become a potential alternative to spinal arthrodesis. Until recently, there has been no standardized method for evaluating the wear of an artificial disc and myriad testing conditions have been used. The American Society for Testing and Materials (ASTM) and International Organization of Standardization (ISO) recently published guidance documents for the wear assessment of intervertebral spinal disc prostheses; however, various kinematic profiles are suggested, leading to different wear paths between the articulating surfaces of the implants. Since the wear between materials is influenced by the type of relative motion, it is important to select test conditions that lead to clinically realistic results. The purpose of this study was to characterize the slide tracks generated by 7 test conditions allowed for by the ISO and ASTM guidance documents and in Euler sequences consistent with 4 commercially available spine wear simulators. The analysis was performed for a ball-in-socket articulation under both lumbar and cervical motion test conditions. Results were generated analytically using a mathematical algorithm and then validated experimentally. Four tests resulted in elliptical sliding tracks of similar geometries for both the lumbar and cervical conditions. Curvilinear and ribbon-shaped wear paths were generated for 3 tests. With the data normalized for implant diameter, the sliding distance was similar between the lumbar and cervical conditions allowed for in the ASTM guidance. This distance differed compared with the results for the ISO guidance document where the lengths of cervical slide tracks were twice those for the lumbar conditions. Slide tracks were also found to be insensitive to the type of simulator under all testing conditions.

The fundamentals of biotribology and its application to spine arthroplasty.

The biological effect of wear of articulating surfaces is a continued concern with large joint replacements and, likewise, of interest for total disc replacements. There are a number of important biotribological testing parameters that can greatly affect the outcome of a wear study in addition to the implant design and material selection. The current ASTM and ISO wear testing standards/guides for spine arthroplasty leave many choices as testing parameters. These factors include but are not limited to the sequence of kinematics and load, phasing, type of lubricant, and specimen preparation (sterilization and artificial aging). The spinal community should critically assess wear studies and be cognizant of the influence of the selected parameters on the test results.

A novel ultra high molecular weight polyethylene-hyaluronan microcomposite for use in total joint replacements. II. Mechanical and tribological property evaluation.

The mechanical and tribological properties of a new biomaterial, an ultra high molecular weight polyethylene-hyaluronan (UHMWPE-HA) microcomposite, were investigated in this article, which is Part II of a two-part study. Part I presented the synthesis and physical/chemical characterization of the novel microcomposites. The microcomposite was developed for bearing surfaces of total joint replacements and was designed to enhance lubrication and improve wear resistance compared to noncrosslinked UHMWPE. Pin-on-flat wear tests with cross-path motion demonstrated significant decreases for both the wear and wear rate of UHMWPE with the presence of hyaluronan (HA) within and on the microcomposite. Compared to noncrosslinked UHMWPE, a maximum decrease of 56% in wear and a maximum decrease of 31% in wear rate were observed at 1.0 million cycles. Inferior tensile properties were observed for the microcomposites when compared to noncrosslinked UHMWPE, which resulted from poor intermolecular entanglement of the UHMWPE caused by low remolding temperature throughout microcomposite manufacturing. Similar results were observed for the sham control, which was processed in the same way as the microcomposite, except for the addition of HA.

Comparison of multistage versus one-stage destabilization of a type II external fixator used to stabilize an oblique tibial osteotomy in dogs.

OBJECTIVE: To compare the biomechanical effects of multistage versus one-stage destabilization of a type II external skeletal fixator (ESF) used to stabilize an oblique unstable tibial osteotomy in dogs. STUDY DESIGN: In vitro, in vivo, and ex vivo experimental study. ANIMAL POPULATION: Twelve healthy adult dogs. METHODS: The biomechanical characteristics of the type II ESF used in this study were determined. This fixator was applied to both tibiae of two groups of 6 dogs to stabilize a 2-mm-wide oblique osteotomy. One fixator on each dog remained unchanged throughout the 11-week study (control group). The fixator on the opposite limb was destabilized late and acutely in one group of dogs (single-stage) and early and progressively in the other (multistage). Clinical examination, radiographic examination, and force-plate analysis were used to evaluate the results. All dogs were euthanatized at 11 weeks. All tibiae were scanned to determine the cross-sectional area of the callus in the center of the osteotomy and subjected to biomechanical tests to determine mean pull-out strength of pins and callus strength and stiffness. RESULTS: Stiffness of the type II ESF used in this study was 578 N/mm in axial compression, 0.767 Nm/deg in torsion, 261 N/mm in medio-lateral bending, and 25 N/mm in cranio-caudal bending. Peak vertical forces of the hindlimbs were significantly lower at 2.5 and 5 weeks than before surgery. Peak vertical forces of the hindlimbs did not change before and after destabilization. No significant differences could be detected between the two destabilization sequences or between all control tibiae and pooled destabilized tibiae with regards to radiographic evaluation of the healing osteotomy, cross-sectional periosteal callus area, mean pull-out strength of transfixation pins, callus strength, and callus stiffness. CONCLUSIONS AND CLINICAL RELEVANCE: Bone healing of unstable osteotomies stabilized with a type II ESF is not significantly enhanced by staged destabilization of the fixation as performed in this study.