Summary of the FDA virtual public workshop on spinal device clinical review held on September 17, 2021.

The mission of Food and Drug Administration (FDA)'s Center for Devices and Radiological Health is to protect and promote public health. It assures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products by providing meaningful and timely information about the products we regulate and the decisions we make. On September 17, 2021, an FDA workshop was held to provide information to stakeholders, including members of the spine community, device manufacturers, regulatory affairs professionals, clinicians, patients, and the general public regarding FDA regulations, guidance and regulatory pathways related to spinal device clinical review. It was not intended to communicate any new policies, processes, or interpretations regarding medical device marketing authorizations. This workshop consisted of individual presentations, group discussions, question and answer sessions, and audience surveys. Information-sharing included discussions related to patient-reported outcomes, clinician-reported outcomes, observer-reported outcomes, and performance outcomes. Discussions involving external subject matter experts covered topics related to spinal device clinical studies including definition of a target population, enrollment criteria, strategies for inclusion of under-represented patient groups, reporting of adverse event and secondary surgical procedures, clinical study endpoints, and clinical outcome assessments. A meeting transcript and webcast workshop link are currently posted on the FDA website. Important related issues and challenges were discussed, and an exciting range of new ideas and concepts were shared which hold promise to advance regulatory science, patient care and future innovation related to spinal devices.

Electrical Stimulation-Mediated Tissue Healing in Porcine Intervertebral Disc Under Mechanically Dynamic Organ Culture Conditions.

STUDY DESIGN: Porcine intervertebral discs (IVDs) were excised and then drilled to simulate degeneration before being electrically stimulated for 21 days while undergoing mechanical loading. The discs were then analyzed for gene expression and morphology to assess regeneration. OBJECTIVE: The purpose of this study was to investigate the effectiveness of the electrical stimulation of IVD treatment as an early intervention method in halting the progression of degenerative disc disease using an ex-vivo porcine model. SUMMARY OF BACKGROUND DATA: Treatments for degenerative disc disease are limited in their efficacy and tend to treat the symptoms of the disease rather than repairing the degenerated disc itself. There is a dire need for an early intervention treatment that not only halts the progression of the disease but contributes to reviving the degenerated disc. METHODS: Lumbar IVDs were extracted from a mature pig within 1 hour of death and were drilled with a 1.5 mm bit to simulate degenerative disc disease. Four IVDs at a time were then cultured in a dynamic bioreactor system under mechanical loading for 21 days, two with and two without the electrical stimulation treatment. The IVDs were assessed using histological analysis, magnetic resonance imaging, and quantitative reverse transcriptase polymerase chain reaction to quantify the effectiveness of the treatment on the degenerated discs. RESULTS: IVDs with electrical stimulation treatment exhibited extensive annular regeneration and prevented herniation of the nucleus pulposus (NP). In contrast, the untreated group of IVDs were unable to maintain tissue integrity and exhibited NP herniation through multiple layers of the annulus fibrosus. Gene expression showed an increase of extracellular matrix markers and antiinflammatory cytokine interleukin-4 (IL-4), while decreasing in pro-inflammatory markers and pain markers in electrically stimulated IVDs when compared to the untreated group. CONCLUSION: The direct electrical stimulation application in NP of damaged IVDs can be a viable option to regenerate damaged NP and annulus fibrosus tissues.

Iatrogenic muscle damage in transforaminal lumbar interbody fusion and adjacent segment degeneration: a comparative finite element analysis of open and minimally invasive surgeries.

PURPOSE: Lumbar procedures for Transforaminal Lumbar Interbody Fusion (TLIF) range from open (OS) to minimally invasive surgeries (MIS) to preserve paraspinal musculature. We quantify the biomechanics of cross-sectional area (CSA) reduction of paraspinal muscles following TLIF on the adjacent segments. METHODS: ROM was acquired from a thoracolumbar ribcage finite element (FE) model across each FSU for flexion-extension. A L4-L5 TLIF model was created. The ROM in the TLIF model was used to predict muscle forces via OpenSim. Muscle fiber CSA at L4 and L5 were reduced from 4.8%, 20.7%, and 90% to simulate muscle damage. The predicted muscle forces and ROM were applied to the TLIF model for flexion-extension. Stresses were recorded for each model. RESULTS: Increased ROM was present at the cephalad (L3-L4) and L2-L3 level in the TLIF model compared to the intact model. Graded changes in paraspinal muscles were seen, the largest being in the quadratus lumborum and multifidus. Likewise, intradiscal pressures and annulus stresses at the cephalad level increased with increasing CSA reduction. CONCLUSIONS: CSA reduction during the TLIF procedure can lead to adjacent segment alterations in the spinal element stresses and potential for continued back pain, postoperatively. Therefore, minimally invasive techniques may benefit the patient.

The Transverse Process Trajectory Technique: An Alternative for Thoracic Pedicle Screw Implantation-Radiographic and Biomechanical Analysis.

BACKGROUND: This study evaluates the accuracy, biomechanical profile, and learning curve of the transverse process trajectory technique (TPT) compared to the straightforward (SF) and in-out-in (IOI) techniques. SF and IOI have been used for fixation in the thoracic spine. Although widely used, there are associated learning curves and symptomatic pedicular breaches. We have found the transverse process to be a reproducible pathway into the pedicle. METHODS: Three surgeons with varying experience (experienced [E] with 20 years in practice, surgeon [S] with less than 10 years in practice, and senior resident trainee [T] with no experience with TPT) operated on 8 cadavers. In phase 1, each surgeon instrumented 2 cadavers, alternating between TPT and SF from T1 to T12 (n = 48 total levels). In phase 2, the E and T surgeons instrumented 1 cadaver each, alternating between TPT and IOI. Computed tomography scans were analyzed for accuracy of screw placement, defined as the percentage of placements without critical breaches. Axial pullout and derotational force testing were performed. Statistical analyses include paired t test and analysis of variance with Tukey correction. RESULTS: Overall accuracy of screw placement was comparable between techniques (TPT: 92.7%; SF: 97.2%; IOI: 95.8%; P = .4151). Accuracy by technique did not differ for each individual surgeon (E: P = .7733; S: P = .3475; T: P = .4191) or by experience level by technique (TPT: P = .1127; FH: P = .5979; IOI: P = .5935). Pullout strength was comparable between TPT and SF (571 vs 442 N, P = .3164) but was greater for TPT versus IOI (454 vs 215 N, P = .0156). There was a trend toward improved derotational force for TPT versus SF (1.06 vs 0.93 Nm/degrees, P = .0728) but not for TPT versus IOI (1.36 vs 1.16 Nm/degrees, P = .74). Screw placement time was shortest for E and longest for T for TPT and SF and not different for IOI (TPT: P = .0349; SF: P < .0001; IOI: P = .1787) but did not vary by technique. CONCLUSIONS: We describe the TPT, which uses the transverse process as a corridor through the pedicle. TPT is an accurate method of thoracic pedicle screw placement with potential biomechanical advantages and with acceptable learning curve characteristics. CLINICAL RELEVANCE: This study provides the surgeon with a new trajectory for pedicle screw placement that can be used in clinical practice.

Clinically relevant finite element technique based protocol to evaluate growing rods for early onset scoliosis correction.

OBJECTIVE: The emergence of distraction-based growing rods has provided the means to reduce the progression of spinal deformity in early onset scoliosis (EOS). The current protocols for evaluating spinal implants (ie, ASTM-F1717 and ISO-12189) were developed for fusion/dynamic devices. These protocols do not feature long unsupported rod lengths subjected to distraction. Due to the unsuitability of the existing guidelines for the evaluation of growing rods, a new distraction-based finite element protocol is presented herein for the first time. METHOD: A vertebrectomy (VO) model from current protocols was modified to accommodate multi-spinal segments (ie, MS model) in which springs with appropriate stiffness were simulated in between the plastic blocks. To assess the efficacy of the protocol, two different computational studies were conducted: (a) compression-bending (MS-CB) with no distraction, and (b) distraction followed by compression-bending (MS-D + CB). In each study, the model with no axial connector (rods-only) was modified to include a) 80-mm long tandem (LT) connectors, and b) side-by-side (SBS) connectors. Stiffness and yield loads were calculated as per ASTM-F1717 guidelines and compared with the corresponding VO models with no distraction. In the MS-D + CB models, distraction was applied at the top block, stretching the spring-block construct in a simulation of scoliosis surgery prior to locking the construct at the connector-rods' interface. RESULTS: MS-CB models predicted higher stiffness and yield loads, compared to the VO models. The locking mechanism produced pre-existing stresses on the rod-connector interface, which caused a shift in the location of high-stress regions to the distraction site. Distraction led to a decrease in the construct's stiffness and yield load. DISCUSSION: The proposed protocol enables the simulation of clinical parameters that are not feasible in the F1717 models and predicted stress patterns in the hardware consistent with observed clinical failures.

Spinal Balance/Alignment - Clinical Relevance and Biomechanics.

In the normal spine due to its curvature in various regions, C7 plumb line (C7PL) passes through the sacrum so that the head is centered over the pelvis-ball and socket hip joints and ankle joints. This configuration leads to the least muscular activities to maintain the spinal balance. For any reason like deformity, scoliosis, kyphosis, trauma, and/or surgery this optimal configuration gets disturbed requiring higher muscular activity to maintain the posture and balance. Several parameters like the thoracic kyphosis (TK), lumbar lordosis (LL), pelvic incidence (PI), sacral slope (SS), Hip- and leg position influence the sagittal balance and thus the optimal configuration of spinal alignment. Global sagittal imbalance is energy consuming and often painful compensatory mechanisms are developed, that in turn negatively influence the quality of life. This review looks at the clinical aspects of spinal imbalance, and the biomechanics of spinal balance as dictated by the deformities- ankylosing spondylitis, scoliosis and kyphosis; surgical corrections- pedicle subtraction osteotomies and long segment stabilizations and consequent postural complications like the proximal and distal junctional kyphosis. This review suggests several potential research topics as well.

Biomechanical Comparison of the Load-Sharing Capacity of High and Low Implant Density Constructs With Three Types of Pedicle Screws for the Instrumentation of Adolescent Idiopathic Scoliosis.

STUDY DESIGN: Biomechanical numerical simulation analysis of implant design and density in adolescent idiopathic scoliosis posterior instrumentation. OBJECTIVES: To evaluate the combined effect of pedicle screw design and density on deformity correction and construct load-sharing capacity. SUMMARY OF BACKGROUND DATA: Screw density is an area of popular study because of the impact of cost and potential patient morbidity of higher-density constructs. Using fewer screws raises concern about reduced correction and greater forces on each screw. METHODS: Personalized spinal numerical models were created for five patients. The correction techniques from five spine surgeons using both a high- and a low-density implant pattern (2 vs. 1.4 ± 0.22 screws/level) with uniaxial, multiaxial, and favored angle screws were simulated. The predicted correction and forces sustained by the implants were compared. The postoperative load-sharing capacity of a high- and a low-density construct, with or without crosslinks, was compared by simulating daily activities motions. RESULTS: The major coronal curve correction was similar with high- and low-density constructs (73% ± 10% vs. 72% ± 10%; p > .05) but was higher when using uniaxial (77% ± 8%) compared to multiaxial (69% ± 11%) and favored angle screws (71% ± 10%; p = .009). High- and low-density constructs sustained similar intraoperative peak forces (305 ± 61 N vs. 301 ± 73 N; p = .23) regardless of screw design (all p > .05). Multiaxial and favored angle screws reduced the peak axial force by 23% and 38% compared to uniaxial screws (p = .007). The high-density construct reduced the postoperative loads sustained by each implant by 31% (p = .006). Crosslinks had no effect on load sharing (p = .23). CONCLUSION: High- and low-density implant patterns achieved similar coronal correction with equivalent capacity to share corrective forces regardless of the screw design. Increased degrees of freedom of the screw head reduces the capacity to correct coronal deformity but generates lower bone-screw forces. The reduced number of screws increased the postoperative forces sustained by each screw, but its effect on potential complications requires further investigations. LEVEL OF EVIDENCE: Level 4.

Time Savings and Related Economic Benefits of Suction-Curette Device for Transforaminal Lumbar Interbody Fusion Discectomy.

BACKGROUND: Performing an adequate transforaminal lumbar interbody fusion (TLIF) discectomy requires numerous instrument passes, increasing surgical time and the risk of complications. The purpose of this study was to evaluate the efficacy and efficiency of discectomy and endplate preparation during TLIF using traditional manual instrumentation versus a novel suction discectomy curette. The direct economic benefit with use of the suction discectomy curette is calculated. METHODS: Three experienced, spine-fellowship-trained surgeons performed TLIF discectomies on 3 cadaveric specimens from T12 to S1 using either traditional manual discectomy instruments or CONCORD Clear (Xtool) devices supplemented with manual discectomy instruments. For each level in which a discectomy was performed, the following were measured: elapsed time, number of instrument passes and the number of instrument exchanges, and estimated tissue volume. RESULTS: Transforaminal lumbar interbody fusion discectomy times improved on average 11:32 minutes per level, which equates to an estimated procedural time savings of 15:85 minutes, using 1.4 levels per TLIF, the average number of levels in a large series. Usage of the CONCORD Clear significantly reduced instrument passes compared to traditional, with a mean of 62.0 for traditional versus 7.1 for CONCORD Clear, an 8.7-fold improvement. Instrument exchanges showed a 5.9-fold improvement, with means of 26.8 and 4.6, respectively. Wet discectomy tissue volume was measured for each discectomy, with a mean of 5.4 cc for traditional versus 12.9 cc for CONCORD Clear, a 2.4-fold improvement. CONCLUSIONS: This study estimates that, in a typical TLIF procedure, over 15 minutes should be saved by using the CONCORD Clear l device (a quarter of the time of a traditional discectomy), and by considering the direct cost-benefit associated with this time savings as well as reduced sterilization costs, it is estimated that a hospital could save approximately $1300 in operating room time and sterilization cost with the use of the CONCORD Clear device in a typical 1-level TLIF procedure.

Does Spanning a Lateral Lumbar Interbody Cage Across the Vertebral Ring Apophysis Increase Loads Required for Failure and Mitigate Endplate Violation.

STUDY DESIGN: Randomized Biomechanical Cadaveric Study-Level II. OBJECTIVE: We aimed to elucidate that placing lateral lumbar interbody cages that span the stronger ring apophysis will require increasing loads for failure, decreasing rates of subsidence, regardless of bone density or endplate integrity. SUMMARY OF BACKGROUND DATA: There are several reports regarding the rates and grades of cage subsidence when utilizing the lateral lumbar interbody fusion technique. However, there is limited data on how spanning the lateral cage across the ring apophysis can prevent it. METHODS: Eight fresh-frozen human spines (L1-L5) were utilized. Each vertebra was placed with their endplates horizontal in an MTS actuator. A total of 40 specimens were randomized into Groups:Load displacement data was collected at 5 Hz until failure. RESULTS: Longer cages spanning the ring apophysis provided more strength in compression with less subsidence relative to shorter cages, regardless of endplate integrity.Longer cages, spanning the ring apophysis, resting on intact endplates (G2) had a significant (P < 0.05) increase in strength and less subsidence when compared with the smaller cage group resting on intact endplates (G1) (P = 0.003).Longer cages spanning the ring apophysis of intact endplates (G2) showed a significant (P < 0.05) increase in strength and resistance to subsidence when compared with similar length cages resting on decorticated endplates (G4) (P = 0.028). CONCLUSION: Spanning the ring apophysis increased the load to failure by 40% with intact endplates and by 30% with decorticated endplates in this osteoporotic cadaveric model. Larger cages that span the endplate ring apophysis could improve the compressive strength and decrease subsidence at the operative level despite endplate violation or osteoporosis. LEVEL OF EVIDENCE: 2.

A Comparative Biomechanical Analysis of Stand Alone Versus Facet Screw and Pedicle Screw Augmented Lateral Interbody Arthrodesis: An In Vitro Human Cadaveric Model.

STUDY DESIGN: Cadaveric biomechanical study. OBJECTIVE: To investigate the kinematic response of a stand-alone lateral lumbar interbody cage compared with supplemental posterior fixation with either facet or pedicle screws after lateral discectomy. SUMMARY OF BACKGROUND DATA: Lateral interbody fusion is a promising minimally invasive fixation technique for lumbar interbody arthrodesis. The biomechanical stability of stand-alone cage placement compared with supplemental posterior fixation with either facet or bilateral pedicle screws remains unclear. METHODS: A 6-degree of freedom spine simulator was used to test flexibility in 7 human cadaveric specimens. Flexion-extension, lateral-bending, and axial-rotation were tested in the intact condition, followed by destabilization through a lateral discectomy at L2-L3 and L4-L5. Specimens were then reconstructed at both operative segments in the following sequence: (1) lateral interbody cage placement; (2) either Discovery facet screws or the Viper F2 system using a transfacet-pedicular trajectory randomized to L2-L3 or L4-L5; and (3) removal of facet screw fixation followed by placement of bilateral pedicle screw instrumentation. Acute range of motion (ROM) was quantified and analyzed. RESULTS: All 4 reconstruction groups, including stand-alone interbody cage placement, bilateral Discovery facet screws, the Viper F2 system, and bilateral pedicle screw-rod stabilization, resulted in a significant decrease in acute ROM in all loading modes tested (P<0.05). There were no significant differences observed between the 4 instrumentation groups (P>0.05). Although not statistically significant, the Viper F2 system resulted in greatest reduction of acute ROM in both flexion-extension and axial rotation versus all other treatments (P>0.05). CONCLUSIONS: Stand-alone interbody cage placement results in a significant reduction in acute ROM at the operative segment in the absence of posterior supplemental fixation. If added fixation is desired, facet screw placement, including the Viper F2 facet screw system using an integrated compression washer and transfacet-pedicular trajectory, provides similar acute stability to the spinal segment compared with traditional bilateral pedicle screw fixation in the setting of lateral interbody cage deployment.

Biomechanical Comparison of 2 Different Pedicle Screw Systems During the Surgical Correction of Adult Spinal Deformities.

STUDY DESIGN: A biomechanical spine model was used to evaluate the impact of screw design on screw-vertebra interface loading during simulated surgical corrections of adult scoliosis. OBJECTIVES: To evaluate differences in screw-vertebra interface forces during adult scoliosis correction between favored angle (FA) screws with extension tabs and standard polyaxial screws while varying deformity severity and curve rigidity. SUMMARY OF BACKGROUND DATA: Pedicle screws enable surgeons to safely and effectively realign spinal deformities. The risk of perioperative screw pullout increases when presented with adult deformities that have less flexible spines and lower bone mineral density. An FA screw with reduction tabs is believed to enable surgical techniques permitting load distribution on multiple screws, thereby reducing screw pullout potential. METHODS: The researchers constructed 3 finite element spine models from adult scoliosis patients. Mechanical properties of intervertebral discs were modeled to reflect less flexible adult spines and their stiffness was varied to evaluate impact on screw-vertebra forces. Models simulated scoliosis surgery according to clinical data using FA or polyaxial screws. Forces measured at the screw-vertebra interface were monitored and compared for each patient with FA and then polyaxial screws. RESULTS: Simulations using FA screws reduced screw-vertebra interface forces significantly compared with polyaxial screws. Favored angle screws caused 18%, 14%, and 16% reductions in peak forces and 29%, 35%, and 22% reductions in average forces compared with polyaxial screws for patients 1, 2, and 3, respectively. Favored angle screws also provided consistent relative reduction in average forces by 28% when varying properties of intervertebral discs among 8, 10, and 12 MPa. CONCLUSIONS: Using a virtual finite element platform, FA screws reduced screw-vertebra interface forces encountered during simulated correction of less flexible adult scoliosis compared with standard polyaxial screws. These results show a potential benefit of using this modified screw design to reduce screw-vertebra forces and potential intraoperative pullout failures.

Comparative in vitro biomechanical analysis of a novel posterior cervical fixation technique versus conventional posterior-based constructs.

STUDY DESIGN: Comparative in vitro, cadaveric biomechanical study. OBJECTIVE: To compare the kinematic response of a new posterior cervical midline surgical technique versus that of conventional fixation techniques. SUMMARY OF BACKGROUND DATA: A new method was designed using alternating bilateral intralaminar screws connected with a single midline rod. This technique provides the theoretical benefits of less operative dissection and reduced implant cost, but the acute flexibility properties remain unknown. Using an in vitro cadaveric model, the study objective was to define the operative level(s) changes in multidirectional flexibility after posterior destabilization/reconstruction from C3 to C6. METHODS: A 6 degree of freedom spine stimulator was used to test flexibility in 7 human cadaveric specimens. Flexion-extension, lateral bending, and axial rotation were tested in the intact condition, followed by destabilization by a simulated posterior column injury from C3 to C6. Specimens were then reconstructed from C3 to C6 and tested in the following sequence: sublaminar hook rod (SH), lateral mass screw rod (LMR), midline laminectomy from C3 to C6 with LMR (MLR), and midline posterior fixation from C3 to C6 (SMF). Range of motion (ROM) and neutral zone were quantified and analyzed. RESULTS: Significant increases in ROM and neutral zone at C3 to C6 were found under all loading conditions for the destabilized condition and intact spine versus all other treatments (P<0.05). The conventional treatments: SH, LMR, and MLR resulted in significantly less ROM than the proposed SMF in flexion-extension and lateral bending (P<0.05). Axial rotation provided similar results; however, no differences were observed between the SH and SMF (P>0.05). Notably, LMR and MLR provided significantly more stability than SH in axial rotation (P<0.05). CONCLUSIONS: Data produced suggest that the new, midline rod fixation approach provides less biomechanical stability than conventional posterior cervical reconstruction techniques. In addition, the high incidence of laminar fracture during screw placement and close proximity of the screw trajectory and polyaxial heads to the dura suggest a practical limitation as well.

Managing design excellence tools during the development of new orthopaedic implants.

Design excellence (DEX) tools have been widely used for years in some industries for their potential to facilitate new product development. The medical sector, targeted by cost pressures, has therefore started adopting them. Numerous tools are available; however only appropriate deployment during the new product development stages can optimize the overall process. The primary study objectives were to describe generic tools and illustrate their implementation and management during the development of new orthopaedic implants, and compile a reference package. Secondary objectives were to present the DEX tool investment costs and savings, since the method can require significant resources for which companies must carefully plan. The publicly available DEX method "Define Measure Analyze Design Verify Validate" was adopted and implemented during the development of a new spinal implant. Several tools proved most successful at developing the correct product, addressing clinical needs, and increasing market penetration potential, while reducing design iterations and manufacturing validations. Cost analysis and Pugh Matrix coupled with multi generation planning enabled developing a strong rationale to activate the project, set the vision and goals. improved risk management and product map established a robust technical verification-validation program. Design of experiments and process quantification facilitated design for manufacturing of critical features, as early as the concept phase. Biomechanical testing with analysis of variance provided a validation model with a recognized statistical performance baseline. Within those tools, only certain ones required minimum resources (i.e., business case, multi generational plan, project value proposition, Pugh Matrix, critical To quality process validation techniques), while others required significant investments (i.e., voice of customer, product usage map, improved risk management, design of experiments, biomechanical testing techniques). All used techniques provided savings exceeding investment costs. Some other tools were considered and found less relevant. A matrix summarized the investment costs and generated estimated savings. Globally, all companies can benefit from using DEX by smartly selecting and estimating those tools with best return on investment at the start of the project. For this, a good understanding of the available company resources, background and development strategy are needed. In conclusion, it was possible to illustrate that appropriate management of design excellence tools can greatly facilitate the development of new orthopaedic implant systems.

Would CoCr rods provide better correctional forces than stainless steel or titanium for rigid scoliosis curves?

STUDY DESIGN: Comparative in vitro, biomechanical study. OBJECTIVE: Compare the effect of rod curvature and material properties on rod flattening and correctional forces. SUMMARY OF BACKGROUND DATA: Traditional methods of correction for large progressive deformities involve 3-dimensional correction, performed with an attempt to reach a balanced correction in all planes, spinal instrumentation, and fusion. Increasing attention to the transverse plane correction has developed after the introduction of segmental pedicle screws into the treatment of idiopathic scoliosis. Approximation of the spine (pedicle screws or hooks) to the rods remains the heart of many deformity procedures. Therefore, it is crucial that the instrumentation used provide and maintain the initial correction of the spinal deformity while minimizing potential intraoperative failures. METHODS: Two experiments were performed using 80 rods made from 4 different materials namely: stainless steel (SS), titanium (Ti), cobalt chromium (CoCr), and ultrahigh strength stainless steel (UHSS). Half of the rods were contoured to 20 degrees, whereas the reaming contoured to 30 degrees. Half of the rods were approximated to a synthetic spine models to measure the flattening of the rods when approximated to highly rigid spine. The other half was used to measure the correctional forces produced by each rod type and curvature. RESULTS: For the 20-degree pre-bend rods, Ti was the best in maintaining its original shape followed by UHSS, SS, and CoCr of 90%, 77%, 62.5%, and 54.4%, respectively. The 30-degree pre-bend showed exactly a similar trend with 80.7% for Ti, 71% for UHSS, 54.6% for SS, and 48.1% for the CoCr rods. For 30-degree pre-bend CoCr and UHSS rods, the intraoperative reduction forces were almost 42% and 10% higher than the Ti and SS rods, respectively. The correctional force produced by the Ti 30-degree pre-bend rod was approximately 67% that of a CoCr and UHSS rods. CONCLUSIONS: CoCr and UHSS rods have the ability to produce the highest correction forces, however, both can plastically deform in a very rigid curves. Therefore, it is critical to have sense of the quality of the bone fixation as well as the curve flexibility when selecting for appropriate rod size material and contouring the rod to the desired shape.

Would an anatomically shaped lumbar interbody cage provide better stability? An in vitro cadaveric biomechanical evaluation.

STUDY DESIGN: A biomechanical cadaveric study of lumbar spine segments. OBJECTIVE: To compare the immediate stability provided by parallel-shaped and anatomically shaped carbon fiber interbody fusion I/F cages in posterior lumbar interbody fusion (PLIF) and transforaminal lumbar interbody fusion (TLIF) constructs with posterior pedicle screw instrumentation. SUMMARY OF BACKGROUND DATA: Few biomechanical data are available on the anatomically shaped cages in PLIF and TLIF constructs. METHODS: Twenty human lumbar segments were tested in flexion-extension (FE) (8 N m flexion, 6 N m extension), lateral bending (LB) (± 6 N m), and torsional loading (± 5 N m). Each segment was tested in the intact state and after insertion of interbody cages in one of 3 constructs: PLIF with 2 parallel-shaped or anatomically shaped cages and TLIF with 1 anatomically shaped cage. All cages received supplementary pedicle screw fixation. The range-of-motion (ROM) values after cage insertion and posterior fixation were compared with the intact specimen values using analysis of variance and multiple comparisons with Bonferroni correction. RESULTS: All constructs significantly reduced segmental motion relative to intact (P < 0.001). The motion reductions in FE, LB, and axial rotation were 85 ± 15%, 83 ± 18%, and 67 ± 6.8% for the PLIF construct using parallel cages, 79 ± 5.5%, 87 ± 10%, and 66 ± 20% for PLIF using anatomically shaped cages, and 90 ± 6.8%, 87 ± 12%, and 77 ± 22% for TLIF with an anatomically shaped cage. In FE and LB, the reductions in the ROM caused between the 3 constructs were equivalent (P > 0.05). In axial rotation, the TLIF cage provided significantly greater limitation in the ROM compared with the parallel-shaped PLIF cage (P = 0.01). CONCLUSIONS: The parallel-shaped and anatomically shaped I/F cages provided similar stability in a PLIF construct. The greater stability of the TLIF construct was likely due to a more anterior placement of the TLIF cage and preservation of the contralateral facet joint.

Direct lateral approach to lumbar fusion is a biomechanically equivalent alternative to the anterior approach: an in vitro study.

STUDY DESIGN: A human cadaveric biomechanical study of lumbar mobility before and after fusion and with or without supplemental instrumentation for 5 instrumentation configurations. OBJECTIVE: To determine the biomechanical differences between anterior lumbar interbody fusion (ALIF) and direct lateral interbody fusion (DLIF) with and without supplementary instrumentation. SUMMARY OF BACKGROUND DATA: Some prior studies have compared various surgical approaches using the same interbody device whereas others have investigated the stabilizing effect of supplemental instrumentation. No published studies have performed a side-by-side comparison of standard and minimally invasive techniques with and without supplemental instrumentation. METHODS: Eight human lumbosacral specimens (16 motion segments) were tested in each of the 5 following configurations: (1) intact, (2) with ALIF or DLIF cage, (3) with cage plus stabilizing plate, (4) with cage plus unilateral pedicle screw fixation (PSF), and (5) with cage plus bilateral PSF. Pure moments were applied to induce specimen flexion, extension, lateral bending, and axial rotation. Three-dimensional kinematic responses were measured and used to calculate range of motion, stiffness, and neutral zone. RESULTS: Compared to the intact state, DLIF significantly reduced range of motion in flexion, extension, and lateral bending (P = 0.0117, P = 0.0015, P = 0.0031). Supplemental instrumentation significantly increased fused-specimen stiffness for both DLIF and ALIF groups. For the ALIF group, bilateral PSF increased stiffness relative to stand-alone cage by 455% in flexion and 317% in lateral bending (P = 0.0009 and P < 0.0001). The plate increased ALIF group stiffness by 211% in extension and 256% in axial rotation (P = 0.0467 and P = 0.0303). For the DLIF group, bilateral PSF increased stiffness by 350% in flexion and 222% in extension (P < 0.0001 and P = 0.0008). No differences were observed between ALIF and DLIF groups supplemented with bilateral PSF. CONCLUSION: Our data support that the direct lateral approach, when supplemented with bilateral PSF, is a minimally invasive and biomechanically stable alternative to the open, anterior approach to lumbar spine fusion.

Do design variations in the artificial disc influence cervical spine biomechanics? A finite element investigation.

Various ball and socket-type designs of cervical artificial discs are in use or under investigation. Many artificial disc designs claim to restore the normal kinematics of the cervical spine. What differentiates one type of design from another design is currently not well understood. In this study, authors examined various clinically relevant parameters using a finite element model of C3-C7 cervical spine to study the effects of variations of ball and socket disc designs. Four variations of ball and socket-type artificial disc were placed at the C5-C6 level in an experimentally validated finite element model. Biomechanical effects of the shape (oval vs. spherical ball) and location (inferior vs. superior ball) were studied in detail. Range of motion, facet loading, implant stresses and capsule ligament strains were computed to investigate the influence of disc designs on resulting biomechanics. Motions at the implant level tended to increase following disc replacement. No major kinematic differences were observed among the disc designs tested. However, implant stresses were substantially higher in the spherical designs when compared to the oval designs. For both spherical and oval designs, the facet loads were lower for the designs with an inferior ball component. The capsule ligament strains were lower for the oval design with an inferior ball component. Overall, the oval design with an inferior ball component, produced motion, facet loads, implant stresses and capsule ligament strains closest to the intact spine, which may be key to long-term implant survival.

Models that incorporate spinal structures predict better wear performance of cervical artificial discs.

BACKGROUND CONTEXT: Wear simulators and their corresponding wear predictive models provide limited information on wear characteristics of artificial discs. Analyses in previous studies that controlled loading profiles according to International Standards Organization (ISO)/American Society for Testing and Materials standards did not account for factors such as the influence of anatomic structures. Retrieval analyses reveal failure modes that are not observed in benchtop simulations and thus indicate deficiencies associated with existing approaches. PURPOSE: To understand the impact of the adjoining spinal structures of a ligamentous segment on the wear of an artificial cervical disc. STUDY DESIGN: Prediction of wear in artificial disc implants (total disc replacement [TDR]) in situ using finite element modeling. METHODS: A novel predictive finite element model was used to evaluate wear in a simulated functional spinal unit (FSU). A predictive finite element wear model of the disc alone (TDR Only) was developed, along the lines of that proposed in the literature. This model was then incorporated into a ligamentous C5-C6 finite element model (TDR+FSU). Both of these models were subjected to a motion profile (rotation about three axes) with varying preloads of 50 to150 N at 1 Hz, consistent with ISO 18192. A subroutine based on Archard law simulated abrasive wear on the polymeric core up to 10 million cycles. The TDR+FSU model was further modified to simulate facetectomy, sequential addition of ligaments, and compressive load; simulations were repeated for 10 million cycles. RESULTS: The predicted wear patterns in the isolated disc (TDR Only) and in TDR+FSU were completely inconsistent. The TDR+FSU model predicted localized wear in certain regions, in contrast to the uniformly distributed wear pattern of the TDR-only model. In addition, the cumulative volumetric wear for the TDR-only model was 10 times that of the TDR+FSU model. The TDR+FSU model also revealed a separation at the articulating interface during extension and lateral bending. After facetectomy, the wear pattern remained lopsided, but linear wear increased eightfold, whereas volumetric wear almost tripled. This was accompanied by a reduction in observed liftoff. The addition of anterior longitudinal ligament/posterior longitudinal ligament did not affect volumetric or linear wear. On the removal of all ligaments and facet forces, and replacement of follower load with a compressive load, the wear pattern returned to an approximation of the TDR-only test case, whereas the cumulative volumetric wear became nearly equivalent. In this case, the liftoff phenomenon was absent. CONCLUSIONS: Anatomic structures and follower load mitigate the wear of an artificial disc. The proposed model (TDR+FSU) would enable further study of the effects of clinical parameters (eg, surgical variables, different loading profiles, different disc designs, and bone quality) on wear in these implants.

Biomechanical comparison of anterior, posterior, and circumferential fixation after one-level anterior cervical corpectomy in the human cadaveric spine.

STUDY DESIGN: In vitro biomechanical study of cadaveric cervical spine. OBJECTIVE: To compare the rigidity of the cervical spine after anterior, posterior, and circumferential fixation after 1-level corpectomy, and evaluate the effects of the integrity of the facet capsules and posterior ligaments (PL). SUMMARY OF BACKGROUND DATA: Anterior cervical corpectomy is commonly used for decompression of the spinal canal in the treatment of different pathologic conditions. The effect of the integrity of the facet capsules and PLs on the biomechanical stability provided by anterior, posterior, or circumferential fixation following 1-level corpectomy has not been investigated. METHODS: Nine cadaveric cervical spines were potted rostrally at C2, and caudally at T1-T2, and were tested in 6 directions with pure moment application, in 5 conditions: In the intact spine, after a C5 corpectomy and anterior fixation, after anterior fixation and disruption of the C4-C5 and C5-C6 facet capsules and PL, after circumferential fixation, and after posterior fixation alone without anterior cage. Angular motion of C4 relative to C6 was measured. RESULTS: Despite C5 corpectomy, anterior grafting and plate fixation was more rigid than the intact spine with all loads in flexion, at loads of 0.5 Nm and 1.0 Nm in right axial rotation and right lateral bending, and at all loads in left lateral bending. Posterior ligamentous disruption increased motion in the coronal and axial planes, but not in the sagittal plane. Circumferential instrumentation resulted in a significant reduction in motion of the spine compared with anterior instrumentation in both the coronal and axial planes but not in the sagittal plane. Posterior fixation without anterior cage failed to limit cervical spine motion in the sagittal plane, but was restrictive in axial rotation and lateral bending when compared with circumferential fixation. CONCLUSION: After C5 corpectomy, with intact PLs and facet capsules, anterior instrumentation is sufficient for spinal stabilization as the resultant construct is more rigid than the intact state. In the presence of C5 corpectomy with PL and bilateral facet capsule disruption, anterior plus posterior instrumentation is more rigid than anterior instrumentation alone in the axial and coronal planes and more rigid than posterior instrumentation without anterior cage in the sagittal plane.

Motion-preserving technologies for degenerative lumbar spine: The past, present, and future horizons.

Over the past few decades, remarkable advancements in the understanding of the origin of low-back pain and lumbar spinal disorders have been achieved. Spinal fusion is generally considered the "gold standard" in the treatment of low-back pain; however, fusion is also associated with accelerated degeneration of adjacent levels. Spinal arthroplasty and dynamic stabilization technologies, as well as the continuous improvement in diagnosis and surgical interventions, have opened a new era of treatment options. Recent advancements in nonfusion technologies such as motion-preservation devices and posterior dynamic stabilization may change the gold standard. These devices are designed with the intent to provide stabilization and eliminate pain while preserving motion of the functional spinal unit. The adaption of nonfusion technologies by the surgical community and payers for the treatment of degenerative spinal conditions will depend on the long-term clinical outcome of controlled randomized clinical studies. Although the development of nonfusion technology has just started and the adoption is very slow, it may be considered a viable option for motion preservation in coming years. This review article provides technical and surgical views from the past and from the present, as well as a glance at the future endeavors and challenges in instrumentation development for lumbar spinal disorders. © 2011 SAS - The International Society for the Advancement of Spine Surgery. Published by Elsevier Inc. All rights reserved.