Current benchtop protocols are not appropriate for the evaluation of distraction-based growing rods: a literature review to justify a new protocol and its development.

PURPOSE: Although distraction-based growing rods (GR) are the gold standard for the treatment of early onset scoliosis, they suffer from high failure rates. We have (1) performed a literature search to understand the deficiencies of the current protocols, (2) in vitro evaluation of GRs using our proposed protocol and performed a finite element (FE) model validation, and (3) identified key features which should be considered in mechanical testing setups. METHODS: PubMed, Embase, and Web of Science databases were searched for articles published on (a) in vivo animal, in vitro cadaveric, and biomechanical studies analyzing the use of GRs as well as (b) failure mechanisms and risk factors for GRs. Both FE and benchtop models of a proposed TGR test construct were developed and evaluated for two cases, long tandem connectors (LT), and side-by-side connectors (SBS). The test construct consisted of five polymer blocks representing vertebral bodies, joined with springs to simulate spinal stiffness. The superior and inferior blocks accepted the pedicle screw anchors, while the three middle blocks were floating. After the pedicle screws, rods, and connectors were assembled onto this construct, distraction was performed, mimicking scoliosis surgery. The resulting distracted constructs were then subjected to static compression-bending loading. Yield load and stiffness were calculated and used to verify/validate the FE results. RESULTS: From the literature search, key features identified as significant were axial and transverse connectors, contoured rods, and distraction, distraction being the most challenging feature to incorporate in testing. The in silico analyses, once they are validated, can be used as a complementing technique to investigate other anatomical features which are not possible in the mechanical setup (like growth/scoliosis curvature). Based on our experiment, the LT constructs showed higher stiffness and yield load compared to SBS (78.85 N/mm vs. 59.68 N/mm and 838.84 N vs. 623.3 N). The FE predictions were in agreement with the experimental outcomes (within 10% difference). The maximum von Mises stresses were predicted adjacent to the distraction site, consistent with the location of observed failures in vivo. CONCLUSION: The two-way approach presented in this study can lead to a robust prediction of the contributing factors to the in vivo failure.

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.

Toward spinal cord injury repair strategies: peptide surface modification of expanded poly(tetrafluoroethylene) fibers for guided neurite outgrowth in vitro.

Expanded poly(tetrafluoroethylene) fibers were surface modified using an ultraviolet-activated mercury/ammonia reaction to yield amine-functional groups for the coupling of laminin-derived cell adhesive peptides CYIGSR, CDPGYIGSR, CIKVAV, and CQAASIKVAV. Surface elemental composition, determined by X-ray photoelectron spectroscopy, and radiolabeling data indicated that the amount of peptide introduced was approximately equivalent regardless of peptide type, yet mixed peptide surfaces had approximately 60% YIGSR and 40% IKVAV. The peptide-modified surfaces were compared in terms of the response of dorsal root ganglia with neurite length and number of cells attached to each fiber measured. All peptide-functionalized surfaces had a greater cellular response than the aminated ePTFE and ePTFE controls. Surfaces modified with extended peptide sequences CDPGYIGSR and CQAASIKVAV demonstrated a greater cellular response than those modified with the shorter peptide sequences CYIGSR and CIKVAV, respectively, likely because the extended peptides more closely mimic the three-dimensional conformation that the peptides maintain in laminin. Differences in neurite extension were evident among the peptide-functionalized surfaces, with the longest neurites observed on surfaces modified with both CQAASIKVAV and CDPGYIGSR. The "guidance capacity" of the fibers as a function of fiber diameter was investigated in terms of length and directionality of neurite outgrowth. As fiber diameter decreased (from 100+ to 10 microm), the neurites tended to grow to a greater degree down the length of the fiber. The thinnest fibers (with diameters <20 microm) extended shorter neurites than the fibers with a wider diameter. Combining neurite length with guidance indicated that of the fiber diameters investigated, the optimal fiber diameter for neurite guidance was between 30 and 50 microm.