Biomechanical evaluation of the Total Facet Arthroplasty System® (TFAS®): loading as compared to a rigid posterior instrumentation system.

PURPOSE: To gain insight into a new technology, a novel facet arthroplasty device (TFAS) was compared to a rigid posterior fixation system (UCR). The axial and bending loads through the implants and at the bone-implant interfaces were evaluated using an ex vivo biomechanical study and matched finite element analysis. Kinematic behaviour has been reported for TFAS, but implant loads have not. Implant loads are important indicators of an implant's performance and safety. The rigid posterior fixation system is used for comparison due to the extensive information available about these systems. METHODS: Unconstrained pure moments were applied to 13 L3-S1 cadaveric spine segments. Specimens were tested intact, following decompression, UCR fixation and TFAS implantation at L4-L5. UCR fixation was via standard pedicle screws and TFAS implantation was via PMMA-cemented transpedicular stems. Three-dimensional 10 Nm moments and a 600 N follower load were applied; L4-L5 disc pressures and implant loads were measured using a pressure sensor and strain gauges, respectively. A finite element model was used to calculate TFAS bone-implant interface loads. RESULTS: UCR experienced greater implant loads in extension (p < 0.004) and lateral bending (p < 0.02). Under flexion, TFAS was subject to greater implant moments (p < 0.04). At the bone-implant interface, flexion resulted in the smallest TFAS (average = 0.20 Nm) but greatest UCR (1.18 Nm) moment and axial rotation resulted in the greatest TFAS (3.10 Nm) and smallest UCR (0.40 Nm) moments. Disc pressures were similar to intact for TFAS but not for UCR (p < 0.04). CONCLUSIONS: These results are most applicable to the immediate post-operative period prior to remodelling of the bone-implant interface since the UCR and TFAS implants are intended for different service lives (UCR--until fusion, TFAS--indefinitely). TFAS reproduced intact-like anterior column load-sharing--as measured by disc pressure. The highest bone-implant moment of 3.1 Nm was measured in TFAS and for the same loading condition the UCR interface moment was considerably lower (0.4 Nm). For other loading conditions, the differences between TFAS and UCR were smaller, with the UCR sometimes having larger values and for others the TFAS was larger. The long-term physiological meaning of these findings is unknown and demonstrates the need for a better understanding of the relationship between spinal arthroplasty devices and the host tissue as development of next generation motion-preserving posterior devices that hope to more accurately replicate the natural functions of the native tissue continues.

Off-label use of bone morphogenetic proteins in the United States using administrative data.

STUDY DESIGN: Epidemiological study using national administrative data. OBJECTIVE: To evaluate the temporal trends in on-label and off-label bone morphogenetic protein (BMP) usage in primary and revision spine fusion by spine region and surgical approach, and nonspine applications in the United States from 2002 to 2007. SUMMARY OF BACKGROUND DATA: The prevalence of BMP usage for spine fusion has been on the rise, but its use has not been stratified by surgical approach, particularly for lumbar fusion where it has only been Food And Drug Administration-approved for anterior lumbar interbody fusion (ALIF). METHODS: The prevalence of BMP usage in the United States was evaluated using the Nationwide Inpatient Sample between October 1, 2002 and December 31, 2007. The Nationwide Inpatient Sample is the single largest all-payer inpatient care database in the United States. The principal procedure associated with BMP use was determined, and the prevalence of BMP use was calculated for various population subgroups. RESULTS: A total of 340,251 inpatient procedures with BMP usage were identified. Between 2003 and 2007, the annual number of procedures involving BMP increased by 4.3-fold from 23,900 to 103,194. Spine fusion accounted for the vast majority (92.8%) of principal procedures with BMP. The predominant use of BMP was in primary posterior lumbar interbody fusion or transforaminal lumbar interbody fusion (PLIF/TLIF) (30.0%), followed by primary posterolateral spine fusion (20.4%), primary ALIF (16.6%), primary cervical fusions (13.6%), and primary thoracolumbar fusions (3.9%). Of primary ALIF with BMP, 19.3% did not involve the implantation of an interbody device. CONCLUSION: At least 85% of principal procedures using BMP were for off-label applications. With uncertainty regarding the risks of using BMP in certain off-label applications, further research will be needed to better define the appropriate indications. Our study also demonstrates that disparities in the differential rates of BMP use exist in the spine fusion population.

Quality of motion considerations in numerical analysis of motion restoring implants of the spine.

BACKGROUND: Motion restoring implants function in a dynamic environment that encompasses the full range of spinal kinematics. Accurate assessment of the in situ performance of these devices using numerical techniques requires model verification and validation against the well-established nonlinear quality of motion of the spine, as opposed to the previous norm of matching kinematic endpoint metrics such as range of motion and intervertebral disc pressure measurements at a single kinematic reference point. METHODS: Experimental data was obtained during cadaveric testing of nine three-functional spinal unit (L3-S1) lumbar spine segments. Each specimen was tested from 8 Nm of applied flexion moment to 6 Nm of applied extension moment with an applied 400 N compressive follower preload. A nonlinear kinematic curve representing the spinal quality of motion (applied moment versus angular rotation) for the index finite element model was constructed and compared to the kinematic responses of the experimental specimens. The effect of spinal soft tissue structure mechanical behaviors on the fidelity of the model's quality of motion to experimental data was assessed by iteratively modifying the material representations of annulus fibrosus, nucleus pulposus, and ligaments. FINDINGS: The present work demonstrated that for this model, the annulus fibrosus played a small role in the nonlinear quality of motion of the model, whereas changes in ligament representations had a large effect, as validated against the full kinematic range of motion. An anisotropic continuum representation of the annulus fibrosus was used, along with nonlinear fabric representations of the ligaments and a hyperelastic representation of the nucleus pulposus. INTERPRETATION: Our results suggest that improvements in current methodologies broadly used in numerical simulations of the lumbar spine are needed to fully describe the highly nonlinear motion of the spine.

Polyethylene wear and rim fracture in total disc arthroplasty.

BACKGROUND CONTEXT: Polyethylene (PE) has been used in total disc replacements (TDRs) in Europe since the 1980s. However, the extent of surface damage of PE, including rim fracture and wear, after long-term implantation remains poorly understood. PURPOSE: The purpose of this study was to evaluate the magnitude and rate of PE wear and surface damage in TDRs. STUDY DESIGN: TDR components were retrieved from patients undergoing revision TDR surgery and conversion to fusion. PATIENT SAMPLE: Twenty-one implants (SB Charité III; DePuy Spine, Raynham, MA) were analyzed from 18 patients (12 female, 6 male) undergoing TDR revision surgery. The components were implanted between 1.8 and 16.0 years (average: 7.8 years) at L2-L3 (n=1), L3-L4 (n=1), L4-L5 (n=11), and L5-S1 (n=8). They were removed due to pain (in all cases) and were associated with subsidence (n=6), anterior migration (n=2), core dislocation (n=2), lateral subluxation (n=1), wear with wire marker fracture (n=1), end plate loosening (n=2), and osteolysis (n=1). OUTCOME MEASURES: Clinical information was collected from medical records and radiographs. Retrieval analysis included dimensional measurements and assessment of the extent and severity of PE surface damage mechanisms. METHODS: MicroCT scanning was used to identify the presence of internal cracks in the PE core and to scan the geometry of the retrievals. Light microscopy, coupled with white light interferometry, was used to evaluate the surface damage mechanisms at the dome and rim. RESULTS: The dominant wear mechanism was adhesive/abrasive wear at both the dome and rim. End plate penetration (dome wear) ranged from 0.1 to 0.9 mm (average: 0.3 mm), and was correlated with implantation time (Spearman's rho=0.48, p=.03). There was also evidence of macroscopic rim damage, including radial and transverse cracking, fracture, plastic deformation, and third-body damage. End plate penetration measured at the rims ranged from 0.02 to 0.8 mm (average: 0.3 mm). Cracks in the core were oriented transversely in 11 of 21 implants (52%), and radially around the rim in 11 of 21 implants (52%). Radiographic wire marker fracture, observed in 9 of 21 implants (43%), was always associated with deformation, cracking, or fracture of the PE rim. In two cases, a fractured wire marker became lodged in the articulating surface between the PE and the metallic end plate. CONCLUSIONS: This is the first study to quantitatively analyze the long-term PE damage mechanisms in contemporary TDRs. The TDRs displayed surface damage observed previously in both hip and knee replacements. Because of the evidence of increasing wear with implantation time, along with the demonstrated potential for osteolysis in the spine, regular long-term follow-up for patients undergoing TDRs is warranted.

Wear and corrosion in retrieved thoracolumbar posterior internal fixation.

STUDY DESIGN: Posterior thoracolumbar spine implants retrieved as part of routine clinical practice over a 2-year period were analyzed to identify wear and corrosion. OBJECTIVE: Engineering analyses of retrieved posterior instrumentation for indications of performance and failure and correlation of this information with clinical factors. SUMMARY OF BACKGROUND DATA: Recent studies have reported spinal instrumentation particulate wear debris and have noted the importance of design considerations at implant connector interfaces. METHODS: A total of 57 implants were analyzed from patients (39 female, 18 male) whose average age at implantation was 43.9 years (range, 13.7-77.4 years). Time of implantation ranged from 2 months to 13.5 years. The top 3 implantation diagnoses were radiculopathy (33%), scoliosis (30%), and back pain (25%). Metallurgical analyses were performed to characterize the wear and/or corrosion, and fractures of the implants. RESULTS: Wear was present in 75%, corrosion in 39%, and fractures in 7% of the retrieved implants. Wear and/or corrosion was more prevalent, with respect to the total number of implants retrieved, in implants that had been in service at least 1 year. There was no evidence of corrosion in any of the Ti implants, whereas corrosion was present (with wear) in 58% of the stainless steel (SS) implants. Wear and corrosion were more frequently observed in long rods than in short rods. Implantation times were longer for SS implants than for Ti implants. CONCLUSIONS: Retrieved rods exhibited corrosion, wear, and fracture, with wear and corrosion mainly located at the interfaces with hooks, screws, or cross-connectors. The mechanisms causing this material loss in situ, as well as what local or systemic responses it may stimulate are of clinical significance and should be studied further.

Analysis of a retrieved polyethylene total disc replacement component.

BACKGROUND CONTEXT: Although total disc replacements have been performed in Europe since the 1980s, this type of surgery is still new in the United States. The clinical performance of polyethylene in total disc replacements is still not well understood. PURPOSE: To describe the wear, surface damage, oxidation and mechanical properties in an explanted polyethylene total disc replacement component. STUDY DESIGN/SETTING: Case report, analysis of retrieved implant. PATIENT SAMPLE: Case report. OUTCOME MEASURES: Analysis of wear, oxidation and mechanical properties in the retrieved total disc replacement. METHODS: A 49-year-old female patient was implanted at L5-S1 with an SB Charite total disc prosthesis (DePuy Spine, Raynham, MA). After 1.6 years, the patient underwent a posterior, instrumented fusion because of intractable low back, left buttock and radicular left leg pain. Preoperative diagnostics revealed loosening at the bone implant interface at L5 and S1, anterior migration of the L5 base plate and severe degeneration of the L5-S1 facet joints. The retrieved polyethylene core showed evidence of damage around the periphery or rim. Transverse, subsurface cracks in the polyethylene, which initiated near the rim and penetrated into the interior of the component, were imaged using thin-film optical microscopy and micro-computed-tomography imaging. Analysis using Fourier transform infrared spectroscopy (American Society for Testing and Materials [ASTM] F2102) documented low levels of oxidation within 1 mm of the articulating surface. Miniature specimen mechanical testing (ASTM F2183), conducted near the surface where the oxidation was greatest, demonstrated that the mechanical properties were not substantially degraded. CONCLUSION: In this case, the anterior revision surgery was difficult and potentially life-threatening. The revision strategy of an instrumented posterior fusion to salvage a failed SB Charite disc replacement may be unpredictable and, in this case, ultimately unsuccessful. Despite the small size of the retrieved polyethylene core, ASTM standard test techniques developed for analysis of retrieved hip and knee replacements were readily adapted for the total disc prosthesis.

The biomechanical effects of kyphoplasty on treated and adjacent nontreated vertebral bodies.

It remains unclear whether adjacent vertebral body fractures are related to the natural progression of osteoporosis or if adjacent fractures are a consequence of augmentation with bone cement. Experimental or computational studies have not completely addressed the biomechanical effects of kyphoplasty on adjacent levels immediately following augmentation. This study presents a validated two-functional spinal unit (FSU) T12-L2 finite element model with a simulated kyphoplasty augmentation in L1 to predict stresses and strains within the bone cement and bone of the treated and adjacent nontreated vertebral bodies. The findings from this multiple-FSU study and a recent retrospective clinical study suggest that changes in stresses and strains in levels adjacent to a kyphoplasty-treated level are minimal. Furthermore, the stress and strain levels found in the treated levels are less than injury tolerance limits of cancellous and cortical bone. Therefore, subsequent adjacent level fractures may be related to the underlying etiology (weakening of the bone) rather than the surgical intervention.

Modeling of the naked facet sign in the lumbar spine.

The study design is a computer visualization model that simulated flexion deformities about the lumbar spine for evaluation of the naked facet sign (NFS). The objectives were to ascertain the angles of rotation required for NFS to occur in the lumbar spine with various centers of rotation about the vertebral body and to assess whether NFS correlates with unstable flexion-distraction injuries in the lumbar spine. The presence of the NFS on axial computed tomography (CT) images occurs when the inferior articulating facet of the cephalad vertebra is not paired with an adjacent superior articulating facet of the caudal vertebra. This sign, when evidenced in the lumbar spine, is suggestive of significant injury secondary to a flexion-distraction force. A previous study using a computer-generated spine model challenged the utility of the NFS in the thoracolumbar spine. The NFS may prove to be more diagnostic of an unstable injury in the lumbar spine because of its normal lordotic resting position. A commercial spine computer visualization model was used to simulate various degrees of flexion injury in the lumbar spine. Lumbar functional spinal units (FSU) L2-L5 were each examined separately. The model simulated two CT scan slices (each 2 mm thick), which were created parallel to the inferior endplate of the cephalad vertebra of each FSU. The cephalad vertebra was rotated in 0.5 degrees increments until NFS was produced. The appearance of NFS required >/=11 degrees kyphotic angulation in more than two thirds of simulated centers of rotation about the lumbar vertebral bodies. The NFS was produced between a range of 8-24.5 degrees. For rotations about a point located 3 cm anterior to the vertebral body (to simulate seat-belt-type flexion-distraction injuries), the minimum angle required for NFS was 7.5 degrees. Our data correlate well with previously published results from in vitro and cadaveric studies. As opposed to the thoracolumbar spine, which normally rests in a neutral position, the lumbar spine normally rests in a lordotic position. Therefore, NFS in the lumbar spine may be more suggestive of an unstable injury and would warrant closer examination of the patient and additional radiographic studies.